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Expert Financial Analysis and Reporting

Cytokinetics: VITALITY-ALS Trial Fails (CYTK, Buy, $8.00)

CYTK announced today that the VITALITY-ALS trial in ALS failed which is obviously a significant disappointment. The stock is trading…
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Alimera : Changing from A Buy to Hold (ALIM, $1.20, Hold)

After four years of following Alimera and never having a Buy on the Company, I upgraded to a Buy in…
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Antares Pharma: My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval (ATRS. Buy, $1.63)

Investment Thesis

Xyosted is viewed by investors as the most important product in Antares” broad pipeline. In anticipation of approval…
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Portola: Management Guides to a Highly Probable US Launch of Bevyexxa in the December to February Timeframe (PTLA, Buy, $50.52)

Perspective on Stock Price Behavior

I began coverage of Portola with a Buy in a May 4, 2017 report at…
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Cryoport: This Unique Company is Poised for Explosive Sales Growth; Price Weakness is a Buying Opportunity (CYRX, Buy, $6.68)

Investment Thesis

By my analysis, Cryoport and its stock are coiled like a spring for future strong performance. My model is…
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Cytokinetics: Even if Tirasemtiv Were to Fail in Vitality-ALS. There is Great Long term Stock Potential (CYTK, $14.25, Buy)

Critical VITALITY-ALS Data Is Imminent

During the 3Q conference call, Cytokinetics said that the still unknown results of the VITALITY-ALS trial of…
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Antares: Approval of Xyosted is a Matter of When, Not If (ATRS, $2.12, Buy)

The Issue

Antares received a complete response letter for Xyosted that did not cite any questions relating to efficacy, manufacturing, quality…
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Antares Pharma: FDA Action to not Approve Xyosted on its October 20, 2017 PDUFA Date is Perplexing (ATRS, Buy, $2.23)

Overview

Investors have had high confidence that Xyosted would be approved by the FDA on its October 20, 2017 PDUFA date.…
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Repligen: More Detailed Analysis on GE Decision to Manufacture Protein A

Overview

GE Healthcare, announced plans to launch a new chromatography resin in the first half of 2018 which will not use…
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Portola: Reiterating Buy and Refuting Recent Negative Blog by Adam F-stein (PTLA, Buy, $54.12)

Introduction

Adam F-stein wrote an article on Portola on September 19, 2017 with the headline “Commercial launch of Portola’s new blood…
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Northwest Biotherapeutics: Thoughts on Why the Phase 3 Trial of DCVax-L is Ongoing (NWBO, BUY, $0.17)

Overview

The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS…
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Northwest Biotherapeutics, Bristol-Myers Squibb: Success for the Yervoy-Opdivo Combination in CHECKMATE-214 Trial Obviously is a Major Positive for BMY, but also has Important Implications for NWBO (NWBO, Buy, $0.19) (BMY, $60.80, Buy)

The stoppage at an interim analysis of Bristol-Myers Squibb’s’ CHECKMATE-214 trial provides meaningful information into assessing the potential fro success…
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Portola: September 4 Conference Call Provides Update on Potential Launch Date for Bevyxxa and Announces Price (PTLA, Buy, $57.29)

Investment Overview

Following approval of Bevyxxa, Portola stated that it expected to launch in the US in the September to November…
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Northwest Biotehrpeutics: How Does DCVax-L Clinical Data Compare to the CAR-T Therapy Axi-Cel? (NWBO, $0.18, Buy)

New Seeking Alpha Article on Seeking Alpha

An article on Seeking Alpha called Northwest Biotherapeutics: Statistically Satisfying was just published by…
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Antares Pharma: This Small, Emerging Biotechnology Company Is Poised for Explosive Growth Based on Five Major New Product Introductions by 2020 (ATRS, Buy, $3.02

Investment Thesis

Antares is one of my top recommendations based on its extremely impressive pipeline prospects. In a March 23, 2017…
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Alimera Sciences: Company Achieves Breakeven Pretax Cash Flow in 2Q, 2017 Despite Slow Unit Demand for Iluvien (ALIM, Buy, $1.50)

Investment Perspective

Alimera’s second quarter results threw investors (and me) a sweeping curve ball. I initiated coverage on May 31, 2013…
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Cryoport: As Its Clients Transition from Clinical Development to Commercial, Growth Could Be Explosive (CYRX, $6.89, Buy)

Investment Perspective

Cryoport is in the very early stages of corporate development and has only minimal sales ($9.8 million on a…
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Portola Pharmaceuticals: AndexXa BLA Resubmitted; Reiterating Buy (PTLA, $61.41, Buy)

Investment Thesis

Portola issued a press release on August 3, 2017 that reported it had just resubmitted the BLA for AndexXa,…
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Cytokinetics: Reiteration of My Long Standing Buy Recommendation Based on an Extraordinary Pipeline (CYTK, $12.90, Buy)

Investment Overview and Thesis

Investment Overview

Cytokinetics reported 2Q, 2017 sales and earnings results on Wednesday, August 2 but this was relatively…
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Cryoport: Upping 2020 Price Target from $14.50 to $20.00 (CYRX, Buy, $6.89)

Overview

Before reading this report, I would suggest reviewing my initriation report on Cryoport of April 12, 2017   and my update…
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My Approach to Investing in CAR-T Drug Development: Cryoport (CYRX, Buy, $5.67)); Kite (KITE, Neutral, $104.34); Juno (JUNO, Neutral, $27.87), Novartis, (NVS, No opinion, $84.85)

Report Highlights

The pending approval of Novartis’ Car-T drug tisagenlecleucel is the beginning of a new era of drugs based…
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Cryoport: Thoughts About FDA AdCom Meeting on Novartis’s CAR-T Drug Tisagenlecleucel (CYRX, Buy, $4.86)

An FDA advisory committee will consider the BLA for Novartis’s CAR-T product tisagenlecleucel tomorrow, July 12th for the treatment of…
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Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)

Overview

This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over…
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Windtree Therapeutics: Phase 2b Trial Fails Although There Was An Encouraging Signal of Activity (WINT, Take tax loss, $0.34)

Key Points:

The phase 2b trial failed, but there was an encouraging signal of activity.
The failure was related to…
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Portola Pharmaceuticals:  Betrixaban Approval Triggers Big Stock Move-Now What Do We Do? (PTLA, Buy, $55.42)

Investment Thesis

There was considerable uncertainty as to whether the FDA would approve betrixaban so that the approval caused a sharp…
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Repligen: Market Likes Spectrum Acquisition and So Do I  (RGEN, Buy, $43.20)

Investment Thesis

I view the acquisition of Spectrum, Inc. as a significant positive for Repligen as I will discuss shortly. I…
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Portola: Reiterating Buy Prior to June 24th PDUFA Date for Betrixaban (PTLA, Buy, $39.35)

Portola has two drugs in late stage development that I believe are likely to be approved in 2017 or early…
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Alimera Sciences: Iluvien Sales Seem to Have Caught Traction; It Is Time to Buy! (ALIM, Buy, $1.35)

Key Points

In 1Q, 2017 unit sales of Iluvien increased 34% in the US and foreign unit sales increased 32%.Management…
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Windtree Therapeutics: Discussion of Licensing Deal with Lee’s Pharmaceutical and Two Imminent Key Clinical Events (WINT, Buy, $0.90)

Introduction

This report discusses a new licensing deal with Lee’s Pharmaceutical and alerts investors to two upcoming catalysts for the stock.…
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Windtree Therapeutics: Thinking About the Stock Price After Phase 2b Results for Aerosurf in RDS Are Released In July (WINT, $0.92)

Investment Thesis

Windtree is facing the ultimate of binary events when it releases topline results in July for its critical phase…
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Cryoport: Observations on 1Q, 2017 Results (CYRX, Buy, $3.05)

Investment Section
 Overview

This report is a follow-up to my April 12, 2017 report “Cryoport: Initiating Coverage of this Highly Unique Health…
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Cytokinetics: What Are the Implications for Tirasemtiv Following the Approval of Radicava (Edaravone) for ALS? (CYTK, Buy, $15.40)

Key Points:

The surprising and unconventional approval of Radicava (edaravone) shows how desperate the FDA is to expedite the approval…
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Portola Pharmaceuticals: Initiating Coverage with a Buy (PTLA, $40.05)

 Overview of Report
I am initiating coverage of Portola Pharmaceuticals with a Buy and a 2021 price target of $426.This is…
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Thoughts on the Probable Launches of the First CAR-T Drugs; Cryoport is a Novel Way to Invest In This: Cryoport (CYRX, Buy, $2.36) and Kite (KITE, Neutral, $83.37)

Key Points:

I continue to think that first ever CAR-T drug approval will be for Novartis’ CTL-019 in r/r pediatric…
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Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)

AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with…
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Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)

Introduction

I am recommending purchase of Cryoport, which has developed a first mover, business model for providing cold chain logistics for…
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Repligen: A Business Update and Reiteration of Buy (RGEN, Buy, $34.11)

Investment Overview and Thesis

A Long Buy Recommendation of Mine

I first recommended Repligen in an initiation report in December 2012. At…
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Cytokinetics: Insights into Corporate Collaborations, Tirasemtiv, CK-107 and Hospitalization Caused by Heart Failure (CYTK, Buy, $11.25)

Introduction

I was just going though the most recently published slide deck of Cytokinetics and found some slides that I thought…
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Kite Pharma: Novartis and Kite File for Regulatory Approval of Their CAR-T Products; I Do Not Believe That KITE Has a Meaningful First Mover Advantage (KITE, Neutral, $82.19)

Key Points:

Novartis will almost certainly gain approval for CTL-019 in r/r pediatric ALL early in 4Q, 2017. This would…
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Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)

Acronyms Used in this Report

SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by…
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Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy)

Key Points:

Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next…
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Cytokinetics: A Look at the Clinical Trial Programs Underway (CYTK, Buy, $13.00)

The Investment Thesis Is Based on Three Drugs in Late Stage Development

In partnership with Amgen, Cytokinetics has advanced omecamtiv mecarbil…
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Cytokinetics: Estimating a Potential 2025 Price Target of $220 Based Only on the Potential for Tirasemtiv (CYTK, Buy, $13.00) and Ignoring Omecamtiv Mecarbil and CK-107

Key Points:

Cytokinetics is likely to report results from the phase 3 VITALITY-ALS trial in early December 2017. I believe…
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Cytokinetics: Estimating a Potential 2025 Price Target of $172 Based Only on the Potential for Omecamtiv Mecarbil and Ignoring Tirasemtiv and CK-107 (CYTK, Buy, $13.00)

Key Points:

Amgen and Cytokinetics have begun enrolling the phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure…
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Kite Pharma: Analysis of Six Month Data from ZUMA-1 That Led to 40% Price Increase (KITE, Neutral, $72.53)

Report Preface

In the event that you are unfamiliar with acronyms used widely in this report such as CAR-T, DLBCL, TFL,…
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Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)

Two Recent Cancer Vaccine Trial Failures Spurred this Report

On February 22, 2017, Argos reported that the Data Monitoring Committee for…
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Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)

Substance of 8-K Regulatory Document

Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been…
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Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)

Key Points:

Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18…
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AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)

Importance of Makena SC to AMAG?

AMAG is engaged in a high stakes clinical development program in which it is endeavoring…
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Cytokinetics: Discussion of Financing Deal with Royalty Partners (CYTK, Buy, $11)

Terms and Implications of This Deal

Cytokinetics announced that it had concluded a deal to sell a portion of the future…
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AMAG and Antares: Update on the Development of Makena SC (AMAG, Neutral, $24.40) (ATRS, Buy, $2.04)

Key Points:

Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of…
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Bristol-Myers Squibb: Disappointing Recent Press Release Causes Sharp Drop in Stock Price; I Remain at Buy (BMY, Buy, $49)

The New Press Release

Bristol-Myers Squibb’s stock declined from $55.49 at the close on Thursday January 19 to $49.23 at the…
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Bristol-Myers Squibb: Implications of Potentially Earlier than Expected Introduction of Keytruda Combined with Chemotherapy in the First Line Lung Cancer Setting (BMY, Buy, $56.31)

Investment overview

Yesterday, BMY traded down sharply due to President-elect Trump’s statements on drug pricing and Merck’s announcement that the FDA…
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SmithOnStocks Top Stock Picks for 2017, January 3, 2017

Purpose of this Report

I last summarized my stock recommendations in a September 12, 2016 report. There has been little change…
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Northwest Biotherapeutics: DCVax-L Viewed Through the Eyes of Dr. Linda Liau, Lead Investigator on the Phase 3 Trial of DCVax-L (NWBO, $0.35, Buy)

Principal Takeaway Messages  from This Report

Dr. Linda Liau believes that use of DCVax-L can result in 25% of glioblastoma patients…
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Updating My Investment Thinking on Kite (KITE, Neutral, $47.63) and Juno (JUNO, Neutrl, 17.86) in the Aftermath of the ASH Meeting

Introduction to Report

I was closely watching the Amercian Society of Hematology (ASH) meeting held during December 3 to 6 for…
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Immuno-Oncology is Probably The Most Explosive Commercial Opportunity in All of BioPharma; My Investment Picks are Bristol-Myers Squibb (BMY, Buy, $57.14) and Agenus (AGEN, Buy, $4.28))

Background Information on Checkpoint Modulation

Let me provide background information that shapes my views on immuno-oncology before I get into my…
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My Current Investment Thinking on Kite (KITE, Neutral, $50.02) and Juno (JUNO, Neutral, $20.14) and the CAR-T Space as a Whole

Key Investment Conclusions

I believe that Juno will cease development of JCAR-015 and turn to JCAR-017 as its lead CAR-T…
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Cytokinetics: Results of COSMIC HF Published in The Lancet; Phase 3 GALACTIC HF Trial Has Started (CYTK, Buy, $12.00)

Key Points

Results from the COSMIC HF phase 2 trial of omecamtiv mecarbil support the hypothesis that it improves heart…
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Northwest Biotherapeutics: Phase 2 Trial in Colorectal Cancer with Liver Metastases Announced (NWBO, Buy, $0.55)

NWBO is preparing for the start of a phase 2 trial combining DCVax-L with Merck’s Keytruda in late stage colorectal cancer with…
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Antares: Teva Projects Launch of AB Rated Generic to EpiPen in Early 2018 (ATRS, Buy, $1.87)

Eyal Desheh is the Chief Financial Officer of Teva. During the recent third quarter conference call, he answered a question…
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Antares: Some Key Points from 3Q, 2016 Conference Call (ATRS, Buy, $1.84)

Investment Opinion

In my opinion, Antares is substantially undervalued. My price target is $6 60 in 2018. The thinking behind this…
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Cytokinetics: My Relative Market Value Analysis Suggests that the Stock Should be Selling at More Than $20 (CYTK, Buy, $8.95)

Investment Thesis

Cytokinetics looks to me to be seriously undervalued when I contrast its market value (stock price multiplied by shares…
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Kite Pharma: Highlights of October 18, 2016 Analysts' Day- I Remain More Cautious on the Stock than Mainstream Wall Street Analysts (KITE, Neutral, $46.45)

Key Points;

The most important data point between now and yearend 2016 is release of data from ZUMA-1 that shows…
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Northwest Biotherapeutics: Recent Data Update on Phase 1/2 Trial of DCVax Direct is Encouraging (NWBO, Speculative Buy, $0.43)

Key Points:

Data for DCVax Direct recently was updated for its phase 1/2 trial in 40 patients having 13 different…
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Kite Pharma: Interpretation of Results from the Interim Look at ZUMA-1 (KITE, Neutral, $60.25)

Overview

Kite released a press release with topline data on the interim look at the ZUMA-1 trial. This note interprets information…
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Kite Pharma Part 5: Detailed Research That I Have Done In Coming to My Opinion on Kite (KITE, Neutral, $$54.06)

Investment Opinion

Kite will be reporting interim results of the phase 2, ZUMA-1 trial of its lead product KTE-C19 by the…
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Antares: Updates on QST and AB Generic to EpiPen; Reiteration of Buy Recommendation (ATRS, Buy, $1.65)

Overview and Investment Opinion

In my opinion, Antares is substantially undervalued. My price target is $6 60 $8 in 2018 and…
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Kite Pharma Part 4: A Preview of Highly Anticipated Results from Interim Look at ZUMA-1 (KITE, Neutral, $54.95)

Key Points:

I think that an imminent press release dealing with topline results from an interim look at the ZUMA-1…
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Kite Pharma Part 3: A Detailed Analysis of the Design of the All-Important ZUMA-1 Trial

Report Overview

This is the third part of the series of reports that I have written on Kite Pharmaceuticals. I…
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Kite Pharma Part 2: An Overview of CAR-T Cell Drug Development Efforts

Overview

This section tries to give a brief, layman’s overview on the potential role of CAR-T cells in treating certain hematological…
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Kite Pharma: Part 1- Glossary of Terms and Acronyms

Introduction

I have been working on a report on Kite for over three months and have in front of me a…
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Cytokinetics; Amgen and Servier Announce Decision to Move Omecamtiv Mecarbil into Phase 3 (CYTK, Buy, $12.07)

Amgen issued a press release today in which it announced that Servier had decided to exercise its option to commercialize omecamtiv…
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Antares; Are Mylan's Woes A Potential Positive for AB Rated Generic to EpiPen (ATRS, $1.37, Buy)

You cannot turn on the business news channels without hearing extensive comments and condemnation by pundits and politicians about Mylan's aggressive…
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Antares: Comment on Strength in the Stock Price (ATRS, $1.29, Buy)

A number of people have asked me if I know of any specific reason for the strength in Antares's stock…
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Cytokinetics: Tirasemtiv Completes Phase 3 Enrollment (CYTK, Buy, $11.89)

Cytokinetics has announced that the VITALITY-ALS trial of tirasemtiv has completed enrollment. The study includes three phases. The first is…
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Celldex: Update Based on 2Q, 2016 Conference Call (CLDX, Neutral, $4.45)

Investment View

Celldex has a broad array of clinical trials underway or in planning that involve five drugs. However, most of…
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Repligen: Very Strong Growth in Sales and Earnings Continues (RGEN, 29.37, Buy)

Investment Thesis

Repligen’s operating business results continue to be very strong as second quarter bioprocessing sales increased 36%. For perspective, full…
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Alimera: Iluvien Sales are Encouraging but the Company is Financially Stressed (ALIM, $1.79, Neutral)

Investment Perspective

I first started writing reports on Alimera in May of 2013, but have never recommended the stock. I thought…
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Agenus: Update on Drug Development Programs (AGEN; Buy, $5.65)

Investment Thesis

This report focuses on product development efforts discussed in Agenus’ 2Q, 2016 conference call. My most likely investment scenario…
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Cytokinetics: Collaboration with Astellas is Expanded and Will Bring in $65 Million of Cash (CYTK, $10.45, Buy)

Overview of Expanded Collaboration

Cytokinetics and Astellas announced on July 27th that they had expanded their collaboration for the development of…
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Galenica to Acquire Relypsa for $32 per Share (RLYP)

Galenica has announced a tender offer to acquire all shares of Relypsa for $32 per share which on a fully…
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A Non-Consensus, More Balanced Look at the CAR-T Development Efforts of Kite and Juno (Kite, $48.53: Juno, $30.42)

Definition of Key Terms Used in This Report

Engineered Autologous T-cells (eACTS): These are T-cells that are removed from a patient…
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Juno Therapeutics: FDA Quickly Lifts Its Clinical Hold on ROCKET

The FDA has decided to lift the clinical hold on the ROCKET trial. Lifting the hold is not a great…
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Juno Therapeutics: Comments on Deaths in the ROCKET CAR-T Clinical Trial of JCAR-015(JUNO, $27.87)

Investment Perspective

I have been watching Kite and Juno for nearly two years and have occasionally written on the companies. I…
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Cytokinetics: Phase 2 Trial of CK-2127107 in COPD Begins (CYTK, $9.37, Buy)

Overview of COPD

Cytokinetics announced today that it is beginning a phase 2 trial of CK-2127107 in chronic obstructive pulmonary disease…
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Antares Pharmaceuticals: Teva Launches AB Generic to Imitrex (ATRS, Buy, $1.06)

Teva announced today the launch of its AB rated generic to Imitex (sumatriptan). Remember that Antares books revenues from Teva…
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AMAG Pharmaceuticals: Initiation of Research on a Complex but Potentially Very Interesting Investment Situation (AMAG, Neutral, $24)

Organization of Report

The first five pages of this report (section 1) provide a quick summary of my view of AMAG’s…
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Northwest Biotherapeutics: Going Over My Thoughts (NWBO, $0.62)

Overview

The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the…
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Relypsa: Company Releases Veltassa Launch Metrics for May (RLYP, $18.14, Buy)

Investment Thesis

Veltassa continues its slow but steady launch. The May results were in line with my projections and I…
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Antares Pharmaceuticals: Highlights on Makena from AMAG Pharmaceuticals Analyst Day (ATRS, $1.14, Buy)

Report Overview

Antares and AMAG Pharmaceuticals are jointly developing a new subcutaneous formulation of AMAG’s key drug Makena which is currently…
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Relypsa: FDA Issuance of a CRL for ZS-9 is a Significant Positive (RLYP, Buy, $18.50)

Investment Thesis

The receipt of a CRL for ZS-9 delays its possible approval by perhaps one year or more which substantially…
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Relypsa: Comments on Possible Outcomes of ZS-9 PDUFA Date

I have previously written that the Veltassa launch sales figures are not likely to excite investors for some time. However,…
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Caladrius Biosciences: The Business Model is Intriguing, But the Cash Position Is Weak (CLBS, $0.57, No Opinion at this time)

Investment Overview

I am interested in Caladrius Biosciences primarily because of the potential for its PCT cell therapy manufacturing business. PCT has…
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Relypsa: Analyzing April Results of the Veltassa Launch (RLYP, Buy, $14.00)

Investment Overview

Investors are closely watching the launch progress of Veltassa following its December 2015 introduction. Medicare and managed care have set…
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Relypsa: Update Following 1Q, 2016 Conference Call (RLYP, Buy, $14.15)

Investment Thesis for Relypsa

The investment issues for Relypsa are complex. Its key drug Veltassa was launched in December of 2015…
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Windtree Therapeutics: Key Points from Conference Call on 1Q, 2016 Results (WINT, $2.04)

Investment Thesis

The current market valuation of Windtree is only $16 million. This seems extremely low for a Company that…
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Chimerix: Thinking on the Stock in the Aftermath of Results from the AdVise Trial (CMRX, $4.95)

Overview

In a report published on April 14th I recommended purchasing Chimerix at a price of $5.67. The catalyst for my recommendation…
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Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)

Report Overview

I usually start my reports with a summary and investment thesis. However, in this report I am putting this…
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Antares: Presentation Highlights from Deutsche Bank Conference (ATRS, Buy, $0.97)

Overview

I listened to CEO Bob Apple speak at the Deutsche Bank conference and wanted to pass along a few pieces…
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Antares: AMAG Issues Guidance on Timing of Subcutaneous Makena (ATRS, Buy, $1/05)

I recently wrote a report on Antares entitled Makena has the Potential to Make a Very Significant Contribution to EPS  that…
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Agenus: Its Market Leading Position in Immuno-Oncology Makes it A Compelling Investment Story (AGEN, Buy, $3.69)

Investment Thesis in Brief

I continue to recommend Agenus for its impressive technology platforms in immuno-oncology. It is difficult to assign…
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Antares: An Outstanding Product Pipeline Promises Dramatic Growth Through 2022 (ATRS, Buy, $0.92)

Investment Thesis in Brief

If you like numbers, you will like this report. It is a very detailed analysis of the…
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Relypsa: Analyzing March Results of the Veltassa Launch (RLYP, Buy, $17.60)

Investment Perspective

Investors are closely watching the launch progress of Veltassa following its December 2015 introduction. Medicare and managed care have…
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Chimerix: An Intriguing Near Term and Long Term Outlook for the Stock (CMRX, Buy, $5.67)

Investment Thesis in Brief
I am recommending purchase of Chimerix at the current price. The failure of brincidofovir in the phase…
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Antares: Makena Has the Potential to Make a Very Significant Contribution to EPS (ATRS, $0.85. Buy)

Investment Thesis
Investment Overview

The launch of Otrexup has been extremely disappointing in contrast to my high expectations. Medac launched a competitive…
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Relypsa: Comments on Takeover Rumors

Reason for Report

Relypsa shares surged from about $15.00 at 1 PM on Thursday April 7 to close at $24.34. This…
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Discovery Laboratories: Clinical Trial Data over Next Year Could Validate the Promise of Aerosurf (DSCO, Buy, $1.60)

Investment Overview

The Stock Market Has Written off Aerosurf

The current stock market valuation for Discovery Laboratories of $13 million (8 million…
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Cytokinetics: Amgen’s R&D Chief Expresses Great Optimism About Omecamtiv Mecarbil for Treating Congestive Heart Failure (CYTK, Buy, $6.53)

Purpose of This Report

I have written frequently about omecamtiv mecarbil, Cytokinetics’ extremely promising new drug for congestive heart failure…
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Northwest Biotherapeutics: A Comprehensive Evaluation of Its Lead Product DCVax-L (NWBO, $1.50)

Perspective and Overview on this Report

The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L…
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Relypsa: It Is Early Days in the Launch of Veltassa but the Momentum Seems Quite Strong (RLYP, Buy, $13.46)

Investment Perspective

Investors are closely watching the launch progress of Veltassa follwoing its December 2015 introduction. Medicare and managed care have…
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Northwest Biotherapeutics: Why the Failure of Celldex’s Rintega in Newly Diagnosed Glioblastoma Probably Has No Implications for the DCVax-L Trial

Investment Thesis

Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed…
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Cytokinetics: Comments on the Patent Situation of Omecamtiv Mecarbil (CYTK, Buy, $6.40)

Introduction

If you read my note of yesterday, there can be no question that Amgen views omecamtiv mecarbil as a major…
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Cytokinetics: Extremely Encouraging News from Amgen on Omecamtiv (CYTK, Buy, $6.54)

Introduction

The Cowen conference in Boston is going on this week. I consider Cowen to have the best and broadest coverage…
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Celldex: ACT IV Trial of Rintega in Newly Diagnosed Glioblastoma has Been Terminated (CLDX, Hold, $4.01)

ACT-IV Trial is Halted

The independent Data Safety and Monitoring Board (DSMB) just completed its second interim review of the phase…
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Antares: Disappointing News on AB Rated Version of EpiPen (ATRS, $0.95)

Investment Perspective

Teva filed a 6-K regulatory document last night that stated: “Teva received a complete response letter on February 23, 2016 relating…
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Relypsa: An In-depth Analysis of Early Results of the Veltassa Launch (RLYP, Buy, $13.26)

Investment Perspective

Relypsa is about two months into the launch of Veltassa, its first product. There was a time (several years…
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Relypsa: New Buy Recommendation on Relypsa (RLYP, Buy, $14.98)

Investment Thinking in Brief
I am beginning coverage of Relypsa (RLYP) with a Buy recommendation. At this point in time, the stock…
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pSivida: One Step Away from Upgrading the Stock (PSDV, Hold, $2.80))

Investment Overview

pSivida holds a unique, leading position in developing inserts that provide long acting delivery of drugs to the retina…
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Cytokinetics: An Update Based on CEO Robert Blum’s Comments at BIO CEO Conference on February 8, 2016 (CYTK, Buy, $6.57)

Summary

I attended the BIO CEO conference in New York City on February 8 and 9. I am writing a series…
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Discovery Laboratories: New CEO and Update on Aerosurf (DSCO, $2.26)

Upcoming Key Events

There are two very important events in the next year. The first is reporting of results in a…
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Neuralstem: An Update on Its Pipeline and Supporting Clinical Trials (CUR, Neutral, $1.00)

Purpose of this Report
Neuralstem has been silent for nearly three months on when the critical phase 2b trial of its…
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Chimerix: Upgrading the Stock to a Buy (CMRX. Buy, $6.10)

Definitions of Key Words

This section defines a number of words, phrases and acronyms that I have used in this report…
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Antares: Undeterred by the Poor Stock Performance I Continue to Pound the Table (ATRS. Buy, $1.30)

Upcoming Catalysts

This is a detailed note updating my thinking on Antares and discussing how I come up with my 2017…
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Derma Sciences: Close to Upgrading (DSCI, $4.54)

Investment Perspective

With the failure of its biotechnology drug candidate aclerastide, Derma Sciences is abandoning drug development efforts. The Company…
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Cytokinetics: An Update on Potential (Highly Probable) Phase 3 Trial of Omecamtiv Mecarbil in Heart Failure (CYTK, Buy, $11.29)

Purpose of this Report

I listened carefully to CEO Robert Blum speaking at the Piper Jaffrey conference on December 1. This…
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Repligen: A Detailed Update; Recent Price Drop Makes Me More Positive (RGEN, Buy, $28.50

Repligen’s Outstanding Business Model

Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment…
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Discovery Laboratories: Results for Aerosurf in Phase 2a Trial are Encouraging; Why Then Did the Stock Crash? (DSCO, Buy, $0.30)

Introduction

This report discusses the results of Discovery Laboratory’s first in human, phase 2a trial of Aerosurf. In writing this report,…
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Cytokinetics: I Predict Amgen Will Proceed to Phase 3 Trials with Omecamtiv Mecarbil (CYTK, Buy, $10.82)

Investment Thesis

I continue with my long standing buy recommendation on the stock. I think a Buy at this level is…
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ZS Pharma: Astra Zeneca to Acquire ZS Pharma at $90 per Share-DARN (ZSPH, $90)

On Friday, November 9, 2015 Astra Zeneca entered into a definitive agreement to buy ZS Pharma in an all-cash tender…
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Antares: An Update on My Investment Thinking (ATRS, Buy, $1.33)

Investment Thesis

This has been a very disappointing year for Antares investors; the stock closed at $2.57 on December 31, 2014…
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Northwest Biotherapeutics: Seeking Alpha Publishes Latest in a String of Attack Articles Authored by Short Sellers (NWBO, $4.92)

Seeking Alpha has published an extremely negative article by anonymous short sellers that alleges criminal misconduct on the part of management…
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Cytokinetics: Positive Topline Results of Omecamtiv in COSMIC-HF Trial Are a Major Positive (CYTK, Buy, $7.04)

There is a very high probability that omecamtiv will now be taken into phase 3 development. I await Amgen’s decision…
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Northwest Biotherapeutics: New Financing from Woodford was Much Needed (NWBO, $5.44)

Curses, Foiled Again; The Hedge Fund’s Lament

The clear intent of the recent short attack on Northwest was at a minimum…
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Northwest: Analysis of a Coordinated Short Selling Attack Against the Stock (NWBO, $4.69)

A Suspect Plunge in Price

On Friday October 16, 2015 a day in which the Dow Jones and S&P averages increased…
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Neuralstem: My Analysis of Phase 1 and Phase 2 Results for NSI-566 Neural Stem Cells in ALS Indicates Encouraging Signals of Efficacy (CUR, Buy, $1.25)

Putting This Report in Perspective 

This is an extensive report that goes over the aggregate results of the phase 1 and…
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Antares: The Stock Price Does Not Reflect the Fundamentals (ATRS, $1.60, Buy)

Introduction

Antares recently updated its corporate presentation on their website. .There were several slides in the presentation that reinforce my confidence…
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Neuralstem: Initial Thoughts on Just Released Encouraging Phase 2 Data on the Use of NSI-566 Stem Cells to Treat ALS. Neuralstem Will Proceed to a Potentially Registrational Trial in 2016 (CUR, Buy, $1.50)

Introduction

Neuralstem released this morning (September 29) new information from principal investigator Eva Feldman on phase 2 data from the use…
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Northwest Biotherapeutics: My Thoughts on the New Data from the Phase 1/2 Trial of DCVax Direct (NWBO, Buy, $6.91)

Critical Issue in Interpreting the Data
Northwest just recently presented length of survival data for 39 patients evaluated in its phase…
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Agenus (AGEN: Buy, $6.61) Royalty Deal for QS-21 Adjuvant Use in Two Glaxo Vaccines

Terms of the Royalty Deal

Agenus announced on September 9th that it had signed a royalty transaction with Oberlan Capital from…
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Northwest Biotherapeutics: Thoughts on Suspension of Screening of New Patients in the Phase 3 DCVax-L Trial

Reason for Report

On August 21, Northwest put out a press release that said that screening of new patients has been…
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Neuralstem: The 2015 Decline in the Stock is in Contrast to Encouraging ALS Data and an Impressive Pipeline (CUR, Buy, $1.38)

Investment Background

Neuralstem has been absolutely pummeled this year as the price has declined from a closing of $2.72 on December…
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Celldex: Meaningful Data on Two Lead Products, Rintega and glembatumumab, is not Likely Before 2017 (CLDX, Hold, $16.99)

Key Points;

The big news of the 2Q, 2015 conference call was that the FDA has discouraged Celldex from filing an…
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Discovery Laboratories: Update from the 2Q, 2015 Conference Call Provides Timelines for Important Aerosurf Phase 2 Trials (DSCO, Buy, $0.47)

Key Points

Phase 2 trials are enrolling rapidly.
Topline results from a trial involving babies of 29 to 34 weeks gestational age…
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Quick Take on Antares Following 2Q, 2015 Conference Call (ATRS, Buy, $2.10)

Investment Opinion

Antares stock has been pummeled by the “so far” disappointing launch of Otrexup and uncertainty as to when or…
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Chimerix: An Update (CMRX, $52.83, Neutral)

Company Description

Chimerix is focused on the development and commercialization of antiviral drugs. Its lead product brincidofovir is a phospholipid derivative…
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Cytokinetics: Comments on Sharp Price Decline After 2Q, 2015 Conference Call (CYTK, Buy, $6.28)

Key Points

The reasons for my buy recommendation on CYTK as detailed in previous reports remain the same. There was nothing…
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Cytokinetics: Phase 3 Trial of Tirasemtiv Has Begun (CYTK, Buy, $7.17)

Cytokinetics announced on July 14, 2015 the start of the phase 3 trial of tirasemtiv in ALS-VITALITY-ALS (Ventilatory Investigation of…
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Discovery Laboratories: What I Intend to Do in the Aftermath of a Disastrous Stock Offering (DSCO, Buy, $0.54)

Quick Summary
Discovery Laboratories has just completed a stock offering that was done at distressed prices. This was a disaster for…
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Repligen: Fundamentals Are Exceptional But The Stock Carries A Premium Valuation (RGEN, $39.97, For Paid Subscribers)

Investment Thesis

When I wrote my first report  on Repligen on December 4, 2012, I concluded that Repligen had one of the…
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Cytokinetics: Phase 3 Trial for Tirasemtiv About to Begin with Topline Results Possible in 2H, 2016; Successful Outcome Could Make the Stock a Homerun (CYTK, $6.35, Buy, For Paid Subscribers)

Introduction

Management has recently provided details of the upcoming phase 3 trial of tirasemtiv in the treatment of ALS; this trial…
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Discovery Laboratories: An Analysis of Phase 2a Results for Aerosurf and What to do with the Stock (DSCO, $0.81, for paid subscribers)

Glossary of Important Definitions

For those of you who are not familiar with terms used in neonatology, I am starting this…
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Antares: One of My Top Stock Picks for 2015 and 2016 (ATRS, Buy, $2.40, For Paid Subscribers)

Introduction to Report

One of my assets is also one of my biggest drawbacks. When I am writing on a Company…
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Observations from ASCO on Immuno-oncology with a Focus on Northwest Biotherapeutics’ (NWBO, Buy, $9.43) DC-Vax-Direct© and the Checkpoint Inhibitors of Bristol-Myers Squibb and Merck

Key Investment Points Stemming from ASCO

I have been going over data presented at ASCO on immune-oncology products and have been…
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Comments on Alimera (ALIM, $4.46, Neutral) and pSivida (PSDV, $3.97, Neutral)

SmithOnStocks Mailbox
About the Mailbox:

My mailbox comments are brief articles on stocks in which I am involved. These can come from…
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Cytokinetics: Takeaways from Recent R&D Day and Reiteration of Buy (CYTK, $6.14, Buy)

Investment Overview

I find the recent stock weakness in Cytokinetics perplexing. The Company has a market value of about $300 million…
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Agenus: Its R&D Day Presentation Puts a Focus on the Great Promise of Cancer Vaccines and Checkpoint Modulators (AGEN, Buy, $6.73)

Overview of Report

I found the Agenus R&D day to be extremely interesting as it showcased the impressive immunotherapy technology base…
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Cytokinetics: Update and Reiteration of My Buy Recommendation (CYTK, $5.54, Buy)

Investment Thesis in Brief
By the end of 2015, Cytokinetics (CYTK) will have tirasemtiv in a phase 3 trial in ALS…
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CAR-T Companies-Kite (KITE, $55.09) and Juno (JUNO, $47.30): Is The Bloom Coming Off The Rose? Are Investor Expectations Unrealistic?

Introduction to This Thought Piece

Emerging biotechnology stocks obviously are very hard to value on an absolute basis because they usually…
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Initiation Report on ZS Pharma (ZSPH, Buy, $40.97, Subscribers only)

ZS Pharma Investment Thesis
The Hyperkalemia Market Opportunity is Huge; There Are No Good Current Drugs

The most important piece of the…
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Antares: Teva Offer to Buy Mylan Should Have No Effect on Launch of AB Rated Generic to EpiPen (ATRS, $2.76, Buy)

Overview

Subsequent to my posting of my recent update on Antares, I have seen that Teva has made an offer to…
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Antares: Detailed Sales and Earnings Projections for 2015 and 2016 (ATRS, Buy, $2.77, subscription required)

Investment Thesis
I continue with my long standing recommendation on Antares. Last year was a disappointing year for the stock, but…
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Discovery Laboratories: Focus is Totally on Aerosurf Development (DSCO, $1.43, Hold)

Investment Thesis

During the conference call on March 16, 2015 discussing 4Q, 2014 results, management announced that it had decided to…
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Northwest Biotherapeutics: Comments on Two AACR Posters (NWBO, $8.62, Buy)

Introduction

I have included an abstract on DCVax Direct and another on DCVax-L that will be presented in poster presentations at…
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Celldex Pipeline Update and Investment Thesis (CLDX, Moving from Buy to Hold, $28.56)

Overview
This report updates my investment thinking on Celldex and also provides a brief overview of its two late stage products.…
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Northwest Biotherapeutics: The $40 Million Woodford Financing is A Major Positive (NWBO, Buy, $7.76)

The $40 million will fund the Company through the end of 2015.
CEO Linda Powers indicates that this is the cornerstone…
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Northwest Biotherapeutics: Still Another Rebuttal to a Feuerstein Attack Is Called For

Introduction

Adam Feuerstein just published a blog that attacks the results and conclusions drawn from the paper summarizing results from the…
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Northwest Biotherapeutics: Promising New Data Was Just Presented on DCVax-L in Recurrent Glioblastoma Multiforme (NWBO, Buy, $7.29)

Executive Summary
Northwest Biotherapeutics has just presented data on 51 patients whom investigators originally intended to enroll in the ongoing, critically…
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Neuralstem: A Closer Look at Encouraging Phase 2 Results for NSI-566 Neural Stem Cells in Treating ALS (CUR, Buy, $2.36)

Observations about the Phase 2 Trial Results

I spent the weekend thinking about the data released in the phase 2 trial…
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Neuralstem: Initial Take on Top Line Results of Phase 2 ALS Trial of NSI-566 Neural Stem Cells (CUR, Buy, $3.08)

The topline data for the phase 2 trial of NSI-566 stem cells were released today. The initial stock reaction indicates…
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Cytokinetics: Updates on Tirasemtiv and Omecamtiv (CYTK, Buy, $7.77)

Investment Overview
I have listened to management presentations at recent brokerage conferences and have then followed up with questions. There are…
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Neuralstem: When Will We See the Phase 2 Data for NSI-566 in ALS? (CUR, Buy, $3.75)

Management has guided that the phase 2 data on 15 patients treated in the phase 2 trial of NSI-566 neural…
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Northwest Biotherapeutics: How Much Will It Cost to Manufacture DCVax-L (NWBO, Buy, $7.26)

There has been a lot of speculation about how much it costs to manufacture one course of individualized therapy of…
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ImmunoCellular Therapeutics: Is There an Investment Case to be Made? (IMUC, $0.57)

Investment Background

The purpose of this report is to get investors re-engaged with ImmunoCellular Therapeutics (IMUC). On December 11, 2013 the…
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Cytokinetics: Key Catalysts for 2015 Strongly Support My Buy Recommendation (CYTK, $7.85)

Catalysts for 2015
During the conference call on February 12, 2015 discussing 4Q, 2014 results Cytokinetics discussed key catalysts for 2015…
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Alimera Sciences: Some Thoughts on the Upcoming US Launch of Iluvien (ALIM, Neutral, $5.29)

Investment Thesis

I have been speaking with ophthalmologists, investors and Alimera (ALIM) management about the upcoming Iluvien launch. As I…
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The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology Landscape (NWBO, Buy, $6.19)

Investment Overview

Linda Powers was invited to the 7th Annual Phacilitate Immunotherapy Forum in Washington D.C. to speak on the potential…
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Alimera Sciences: Will The Launch of Iluvien Be Disappointing to Investors? (ALIM, Neutral, $5.53)

Investment Issues
The investment outlook for Alimera (ALIM) is completely dependent on the commercialization of Iluvien, an ophthalmic implant for the…
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Notes from Linda Powers Presentation in San Francisco, January 12, 2015 (NWBO, Buy, $6.00)

Overview

Linda Powers spoke at the Biotech Showcase Conference in San Francisco on January 12, 2015. My Buy recommendation on Northwest Biotherapeutics…
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Agenus: The Collaboration with Incyte is Transformative and Creates Great Shareholder Value (AGEN, Buy, $4.99)

Incyte’s expertise in clinical development and commercialization of cancer drugs is a perfect complement to Agenus’ product development capabilities for…
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Derma Sciences: Sales Guidance for 2014 is Lowered Again; 2015 Sales Guidance is Given for the First Time (DSCI, Hold, $9.40)

Derma Sciences announced preliminary sales results for 2014 of $83.7 million which represents a 5% increase over 2013. This was…
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Cytokinetics (CYTK, Buy $5.52) New Collaboration with Astellas on CK-2127107 Greatly Improves Investment Outlook

This deal adds a third leg to the development pipeline at Cytokinetics along with omecamtiv for congestive heart failure and…
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Possible Impact of Merck Acqusition of Cubist on the Trius CVR

I was just asked about the potential impact on the value of the Trius CVR of the Merck acquisition of…
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Discovery Laboratories: Delay in Completion of Aerosurf Phase 2a Trial and Continued Disappointing Sales of Surfaxin Weigh on the Stock (DSCO, $1.53, Hold)

Phase 2a Aerosurf trial completion has been pushed back to 1Q, 2015 from 4Q, 2014.
All important topline results from Aerosurf…
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Northwest Biotherapeutics: Putting Recent Clinical Data on DCVax Direct in Perspective (NWBO, Buy, $5.37)

Immuno-oncology is one of the most exciting areas for cancer research and cancer vaccines should be considered as a promising…
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Antares: 2015 Could Be the Breakout Year for the Stock (ATRS, $2.24, Buy)

I project 2015 sales of Otrexup at $22 million; if so, it would be generating profit in the latter half…
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Northwest Biotherapeutics: Capital Raise of $35 Million could be a Positive Catalyst for the Stock (Buy, $5.14)

Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company…
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Celldex, Moving to A Buy (CLDX, $14.16)

Investment Thesis

Celldex held a conference call after the close on Friday, November 14, 2014 to discuss the interim results of…
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Cytokinetics: An Update on Tirasemtiv and Omecamtiv Mecarbil (CYTK, Buy, $3.67)

Investment Thinking

Cytokinetics could announce the decision on whether it will advance tirasemtiv into a pivotal phase 3 trial by the…
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Chimerix: A Review of Recent Analyst Day Presentations with a Focus on Adenovirus and Ebola (CMRX, $31.31, Neutral)

The fundamental outlook for Chimerix is very attractive in my opinion. My model suggests that sales of its lead drug…
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Northwest Biotherapeutics: Exciting News on Potential for Early Patient Access for DCVax-L in the UK

UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program.
Earlier this year,…
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Northwest Biotherapeutics: National Geographic Special Features DCVax Direct Treatment of Stage 4 Pancreatic Cancer Patient (NWBO, Buy, $5.90)

DCVax Direct was used in a patient with stage 4 pancreatic cancer whose chemotherapy was stopped.
The patient, a Nat Geo…
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Antares: Thoughts on FDA Briefing Documents for September 17th Advisory Committee Meeting on Testosterone Replacement Products (ATRS, $2.14, Buy)

The FDA does not appear to be concerned about cardiovascular risk with testosterone replacement products so this is a major…
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ImmunoCellular Therapeutics LTD: Thoughts on Management’s Plan to Move ICT-107 into Phase 3 (IMUC, Neutral, $1.02)

Investment Overview

ImmunoCellular and its dendritic cell cancer vaccine ICT-107 were written off as failures in December of 2013 after it…
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Neuralstem: Previewing Upcoming Important Events and Some Thoughts on the StemCell Patent Infringement Lawsuit (CUR, $3.62 Buy, August 26, 2014)

Key Points

The phase 2 trial of NSI-566 in 15 ALS patients has completed enrollment (surgeries) and final topline data could…
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Antares Pharmaceuticals: An Update on Key Issues (ATRS, Buy, $2.14)

Investment Thesis

Antares (ATRS) common has been hit with a storm of concerns that has caused the stock to decline from…
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Discovery Laboratories: My Current Thinking on the Surfaxin Launch and Aerosurf Phase 2 Trials (DSCO, Buy/Hold, $1.62)

Investment Thesis

At the time of launch of Surfaxin on November 8, 2013 Discovery Laboratory’s (DSCO) stock was selling at $2.00.…
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Northwest Biotherapeutics: Independent Chairman of the DMC Committee for DCVax-L Phase 3 Trial Chastises Adam Feuerstein for Inaccurate Articles (NWBO, Buy, $6.43)

 

The Data Monitoring Committee (DMC) is charged with monitoring the safety and efficacy results of clinical trial. The committee and…
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Cytokinetics: More Thoughts on the Potential for a Phase 3 Trial of Tirasemtiv in ALS (CYTK, Buy, $4.20)

Investment Thesis

In listening carefully to Cytokinetics’ (CYTK) comments over the last three months, I am convinced that the Company will…
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CREW Alleges That Adam Feuerstein is Involved in Stock Manipulation Scheme in Regard to Northwest Biotherapeutics

Citizens for Responsibility and Ethics in Washington (CREW) have gone after Adam Feuerstein of The Street.com. They have accused him…
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Inovio: Successful Phase 2 Trial in Cervical Dysplasia Provides Proof of Concept for the Technology Base (INO, $12.98, Neutral, Subscribers Only)

Inovio’s Immunotherapy Technology Base

Over two decades ago, the creation of naked DNA vaccines gave the promise of a significant advance…
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Northwest Biotherapeutics: Market Research Firm Evaluate Pharma Projects 2020 Worldwide Sales of $2.0 billion for DCVax-L (NWBO, Buy, $5.92)

One of the basic charges made against me by Richard Pearson and other short sellers is that they maintain that…
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Agenus: Encouraging Data on Prophage, But What is the Path Forward (AGEN, Buy, $3.28)

Introduction

On July 1, Agenus announced results from a non-randomized, phase 2 study of its therapeutic cancer vaccine Prophage in newly…
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Antares; My View of How Otrexup and Medac’s New Product Rasuvo May Compete (ATRS, Buy, $2.54)

Investors Are Concerned About Rasuvo’s Impact on Otrexup

Investors have been concerned about the potential effect on Otrexup if the private…
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Cubist Pharmaceuticals: An Overview Based on a Recent Company Presentation (CBST, No Opinion)

Introduction

I recently was invited to attend a broker sponsored conference for biotechnology companies. Altogether, there were 116 companies presenting at…
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Neuralstem: Phase 1b Results for NSI-189 are Very Encouraging but It Is Early Days (CUR, Buy, $4.38, For paid subscribers)

Investment Thesis on Neuralstem

I continue with my long standing buy on Neuralstem that is almost entirely based on the potential…
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Derma Sciences: Highlights of the June 17th Analysts’ Meeting (DSCI, Buy, $11.07, Free content)

Price Target Thinking

In my initiation report of January 31, 2014, I argued for a 2018 price target of $20 to…
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Cytokinetics: I Think That the Company May Decide to Do A Phase 3 Trial with Tirasemtiv (CYTK, $4.70, Buy, For Subscribers Only)

Overview on Clinical Status of Tirasemtiv

I believe that Cytokinetics (CYTK) will decide to move tirasemtiv into phase 3 registration trials…
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Northwest Biotherapeutics: The Investment Tide May be Turning Positive (NWBO, Buy, $6.41, free content)

Purpose of Report

This report goes over recent news on the company in regard to DCVax Direct and DCVax-L and then…
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Repligen Makes An Excellent Acquisition (RGEN, Hold/ Buy, $19.04, free content)

The Bioprocessing Business of Refine Technology

Repligen (RGEN) has just announced the acquisition of Refine Technology. The primary reason for the…
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ImmunoCellular; Thoughts on Its Plan to Move ICT-107 Forward into Phase 3 Trials Based on Data Presented at ASCO (IMUC, $1.34, Neutral, Free Content)

Investment Overview

ImmunoCellular (IMUC) presented an update on the phase 2 results of ICT-107in glioblastoma multiforme or GBM at ASCO in…
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Discovery Laboratories: An Update on the Surfaxin Launch and the Phase 2 Clinical Trial Program for Aerosurf (DSCO, Buy, $1.72)

Introduction and Overview

This note updates recent progress of the company along with my detailed investment outlook which I break into…
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Northwest Biotherapeutics: Management Discusses Interim Data on Phase 1/2 Trial of DCVax-Direct (NWBO, Buy, $6.00, free content)

Introduction

Northwest Biotherapeutics held a conference call on May 27th to discuss interim results of its phase 1/2, first in human,…
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Antares: Although it is Still Early, I Think That Otrexup Launch is Going Very Well (ATRS, Buy, $2.93, Paid subscribers)

Investment Thesis

The broad based business model of Antares results in its receiving revenues from numerous products that are marketed by…
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Chimerix: Moving to a Buy (CMRX, $14.22, Paid subscribers)

Investment Thesis

I wrote a major report on Chimerix on March 13, 2014. I had been working on the report for…
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ImmunoCellular Has Plans to Move ICT-107 Forward into Phase 3 Trials; Should It? (IMUC, $1.19 Trading Buy, For Paid Subscribers)

Investment Overview

ImmunoCellular (IMUC) and its dendritic cell cancer vaccine ICT-107 were written off as failures late last year after the…
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Derma Sciences: An Update and Re-iteration of Buy Recommendation (DSCI, Buy $9.50, For Paid Subscribers)

Investment Perspective in Brief

I am re-iterating my Buy recommendation on Derma Sciences (DSCI) as I believe that it presents an…
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Neuralstem: An In-Depth Look at NSI-189, A Novel Small Molecule Drug Being Studied in Major Depressive Disorder (CUR, Buy, $3.60, For Paid Subscribers)

Investment Thesis

My recommendation of Neuralstem (CUR) has been based primarily on the potential for its neural stem cells NSI-566 in…
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Neuralstem: Dr. Eva Feldman’s Latest Presentation on The Use of CUR’s Stem Cells in ALS (CUR, Buy, $4.04)

Overview
Dr. Eva Feldman is the lead investigator for the clinical trials of Neuralstem’s (CUR) NSI-566 spinal cord stem cells in…
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Repligen Has an Outstanding, Stable Business and Excellent Long Term Growth Potential (RGEN, Hold/ Buy, $14.07, Paid Subscribers Only)

Investment Background and Company Overview
I think that Repligen’s (RGEN) bioprocessing business is one of the best business models that I…
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Ed Quilty, CEO of Derma Sciences, Outlines His Strategy to Build the Premier Wound Healing Company (DSCI, $12.00)

Investment Thesis

I published an extensive report on Derma Sciences (DSCI) on January 31, 2014 in which I recommended purchase. I…
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Linda Powers, CEO of Northwest Biotherapeutics, Attacks and Debunks the Weak Bear Case in a Presentation on March 27

Overview

Northwest Biotherapeutics CEO Linda Powers made a presentation yesterday in which she addressed the bear case that has resulted in…
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Antares (ATRS, Buy, $4.00) Why I Think That the Otrexup Launch Will Be A Success (Paid Subscribers Only)

Recent Price Behavior

Antares’ (ATRS) price has drifted down since the approval of Otrexup for the treatment of rheumatoid arthritis and…
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Agenus (AGEN, Buy, $3.73) Thoughts on the Stock and Company in the Aftermath of Trial Failure of MAGE-A3 Cancer Vaccine

Agenus (AGEN) and GlaxoSmithKline (GSK) announced that the MAGRIT phase 3 study of GSK’s MAGE-A3 cancer vaccine in non-small cell…
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Neuralstem (CUR, Buy, $4.48) Publishing of Phase 1 Results in Annals of Neurology Causes Price Surge (Paid Subscribers Only)

Introduction

The final results of the phase 1 trial of Neuralstem’s (CUR) NSI-566 spinal cord stem cells in the treatment of…
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Chimerix is A Company Focused on Infectious Viral Diseases that Has Investment Characteristics Similar to Trius (CMRX, Neutral, $25.48) (Subscribers Only)

Report In Brief
This report is an in-depth analysis of Chimerix (CMRX). I like the fundamental outlook of this company very…
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Agenus: There Has Been a Positive,Transformational Change in the Investment Thesis (AGEN, $3.67)

This note is based on a presentation that was made by Bob Stein at the BIOCEO conference: he is the…
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Cytokinetics: An In-Depth Look at the Potential for Success of Tirasemtiv in the BENEFIT-ALS Trial in ALS Patients (CYTK, $9.50) (Subscribers Only)

Purpose of This Report

The biggest clinical trial event in all of biotechnology for 2014 could be the reporting of phase…
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The BIO CEO Conference: Highlights from the Meeting and New Investment Perspectives (Subscribers Only)

Back From BIO CEO Conference

I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria…
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Derma Sciences: An In-Depth Look at An Emerging Growth Stock (DSCI, $12.77) (Subscribers Only)

Investment Perspective in Brief

Derma Sciences presents an unusual and attractive biotechnology investment situation. We are all aware of the binary…
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San Francisco Trip Is the Basis for a Preview of 2014 (Subscribers Only)

What SmithOnStocks Is All About
It is traditional at the start of the year to go over stock picks for the…
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pSivida: Why I Think the Stock Could Do Very Well in 2014 (PSDV, $4.12) (Subscribers Only)

Highlights of Dinner
Last night, January 9, pSivida held a dinner for analysts and investors in New York. The audience had…
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Neuralstem: Sizing Up Potential Key Events of 2014 (CUR, $3.42)

Investment Thesis and Overview
Neuralstem’s clinical trial programs and accompanying results for its two key drugs, the neural stem cell product…
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Senesco Offers a New Approach to Cancer Treatment and Dr. Phillip Frost Is Now With the Company (SNTI, $5.31) (Subscribers Only)

Investment Overview

Progress in the treatments of most cancers is a gradual and incremental process in which very few therapies can…
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pSivida: Game On for Iluvien (PSDV, $4.29)

Alimera (ALIM) and pSivida (PSDV) released some extremely encouraging news on Iluvien. They said that Alimera had entered into labeling…
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Agenus: Encouraging Phase II Results for Prophage in Recurrent Glioblastoma (AGEN, $3.00)

Purpose of This Report

Agenus issued a press release on December 16, 2013 in regard to the final results of a…
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ImmunoCellular: Post Hoc Analysis of Disappointing Phase II Trial of ICT-107 (IMUC, $1.02)

Investment Conclusion on ImmunoCellular

The results of the phase II trial of ImmunoCellular's (IMUC) ICT-107 were disappointing as they did not…
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Celldex: I View the Recent Data on Rindopepimut as Encouraging (CLDX, Hold, $22.52) (Subscribers Only)

Report Overview
Celldex released interim data on the ReACT trial of rindopepimut in recurrent glioblastoma at the Society for Neuro-Oncology (SNO)…
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Northwest Biotherapeutics: An Analysis of Its Transforming Balance Sheet Restructuring (NWBO, $4.14)

Key Takeaway Points of this Report
Northwest (NWBO) restructured much of its debt in 4Q, 2012 and also has raised significant…
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Celldex: Equity Offering is a Positive for the Stock (CLDX, Hold, $25.88)

Celldex (CLDX) has just announced a financing in which the Company has issued 7.0 million shares and will receive net…
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Celldex Stay Tuned for Monday’s Conference Call on Rindopepimut (CLDX, Hold, $28.31)

Investment Significance of Upcoming Conference Call
Celldex (CLDX) has raised expectations for positive results for rindopepimut in recurrent glioblastoma. It will…
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Repligen: Looking At 2014 and Beyond- Potential for EPS Growth (RGEN, $12.78) (Subscribers Only)

Investment Thesis

I think that Repligen's (RGEN) bioprocessing businesses is one of the best business models that I have seen in…
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Discovery Laboratories (DSCO, $2.07): An Asymmetric Opportunity

 
Purpose of This Report
This is the first of a series of reports on Discovery Laboratories. Instead of publishing an extensive…
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ImmunoCellular Thoughts on Potential Outcomes for the Phase II Trial of ICT-107 in Newly Diagnosed Glioblastoma (IMUC, $2.31) (Subscribers Only)

Investment Viewpoint
ImmunoCellular has extremely important data upcoming on the phase II trial of ICT-107 in newly diagnosed glioblastoma; topline results…
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Celldex (CLDX, $23.06): Previewing the Imminent Data Release on Rindopepimut

Investment Background and Thesis
In my initial report on Celldex, I highlighted four interesting products that the Company has in development.…
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Celldex Initiation Report: Pipeline Promise Has Been Embraced by Wall Street (CLDX, Hold, $22.79)

Review of Amazing and Volatile Stock Price Performance
From the closing price on December 30, 2011 through October 1, 2013 Celldex’s…
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Agenus and Glaxo: Sizing Up the Potential for the RTS,S Malaria Vaccine (AGEN, $2.94)

Putting Malaria Vaccine Results in Perspective for Agenus
Glaxo (GSK) has just released interim (18 month) results on its phase III…
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pSivida: Previewing the October 17th PDUFA Date for Iluvien (PSDV, $5.07)

Investment Scenarios: The Positive and Negative Case
pSivida (PSDV) has a very important binary event upcoming on October 17, 2013; this…
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Discovery Laboratories: What the Marketing Approval of Surfaxin Could Mean to the Stock (DSCO, $2.72)

Surfaxin is Finally Cleared for Commercialization in the US
The long saga for Discovery Laboratories (DSCO) that began with the first…
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Cytokinetics: Presentation at Heart Failure Society Suggests Myocardial Infarctions Are Not Likely Associated with Omecamtiv Mecarbil (CYTK, $7.61)

Investment Background
Cytokinetics and Amgen first presented data from the ATOMIC HF trial at the European Society of Cardiology Congress (ESC)…
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Agenus: Rebuttal To Attack By Adam Feuerstein on the Company (AGEN, Buy, $2.85)

Report Overview
Adam Feuerstein launched a withering attack on Agenus (AGEN) and me in his column. The gist of the article…
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Neuralstem: Evidence Increasingly Suggests its Neural Stem Cells are Effective in ALS (CUR, $2.57)

Thoughts on the Stock Price
I have been recommending Neuralstem (CUR) since my initiation report of November 5, 2012 at a price of…
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Agenus: Thoughts on Phase II Results for Prophage in Glioblastoma (AGEN, $2.91)

Reason for This Report
Agenus (AGEN) just issued an update on a phase II trial of Prophage G-100 combined with current…
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NovaBay: Phase II Topline Results for Auriclosene in UCBE are Very Encouraging (NBY, $1.52)

Investment Overview
I first recommended NovaBay (NBY) as a small company that fit my asymmetric investment strategy in an initiation report…
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NovaBay: Data from Phase II Trial of Auriclosene in Urinary Catheter Blockage and Encrustation is Imminent (NBY, $1.40)

Company Overview and Purpose of the Report
NovaBay (NBY) will be reporting the results of three Phase II clinical trials involving…
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Agenus: Assessing Stock Prospects in the Aftermath of MAGE A-3 Cancer Vaccine Missing Primary Endpoint in Melanoma (AGEN, $2.81)

Investment Thesis
Glaxo (GSK) announced today that the trial of their MAGE A-3 cancer vaccine in the DERMA trial in stage…
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Cytokinetics: Clinical Investigators’ Take on ATOMIC-AHF Trial Results (CYTK, $8.01)

Introduction
Cytokinetics issued a press release on the results of the phase II trial of ATOMIC-AHF and then held a conference…
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Agenus: Upcoming Clinical Trial Results for the MAGE A-3 Cancer Vaccine Will Have a Major Impact on the Stock (AGEN, $3.42)

Investment Overview
I initiated coverage of Agenus (AGEN) with a Buy on July 17, 2013 based on the pending release of…
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Antares: An In-Depth Look at Otrexup and Re-iteration of My Buy Recommendation (ATRS: $4.45) (Paid Subscribers Only)

Investment Overview and Thesis
Antares has carved out an interesting niche in the pharmaceutical industry through building a drug delivery business…
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Repligen: A Buy and Hold Stock: OPUS Promises to be a Dynamic New Product (RGEN; $9.87)

Report Summary
In this report, I go through a detailed sales, earnings and cash flow projections for the period 2013 through…
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Cytokinetics: A Preview of Key Upcoming Clinical Trial Results (CYTK, $10.17)

Introduction
This report is an update on my thinking on Cytokinetics. It should be read in conjunction with earlier reports, especially…
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Trius Therapeutics to be Acquired by Cubist (TSRX: $13.66)

Implications for Trius Shareholders
Cubist Pharmaceuticals (CBST) and Trius Therapeutics, Inc. (TSRX) announced that they have signed a definitive agreement under…
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Agenus: Key Clinical Events are Imminent (AGEN, $3.91)

Key Value Drivers for Agenus Through 2015
I am initiating coverage of Agenus with a Buy. This basic report goes into…
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How Iluvien May Benefit Alimera and pSivida (PSDV, $3.25)

Investment Perspective on Iluvien

The investment outlooks for pSivida (PSDV) and Alimera (ALIM) in 2013 will be driven by issues related…
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Transcept: Throwing in the Towel on Intermezzo (TSPT, $3.56)

Intermezzo was launched by Transcept’s marketing partner Purdue in April 2012. I believed then and now that it is a…
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Northwest Biotherapeutics: Moving DC Vax-L Rapidly Forward and Starting DC Vax Direct Trials (NWBO, $3.63)

Investment Thesis
This report is an update based on a number of recent events. I discuss encouraging long term survival results…
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Neuralstem: Anticipating More Efficacy Data from ALS Trial (CUR, $1.18)

Investment Opinion and Thesis
I am continuing to recommend purchase of Neuralstem. The Company has completed its first trial in humans,…
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Repligen Promises To Be a Cash Flow Machine (RGEN, $6.88)

Investment Overview
Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment outlook. For many…
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ImmunoCellular Therapeutics: A Close Look at Key Issues for the Ongoing Phase II Trial of ICT-107 (IMUC, $2.69)

Investment Thesis
It is my hypothesis that dendritic cell cancer vaccines have the promise to be a major advance in cancer…
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Cytokinetics: Critical Phase IIB Data is Upcoming in 2013 for Omecamtiv Mecarbil and Tirasemtiv (CYTK, Buy. $6.30)

Key Investment Considerations
 

Cytokinetics Has Two Key Drugs in Phase IIb Development

Cytokinetics (CYTK) has been the pioneer in developing new drugs…
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Discovery Laboratories: The Surfaxin Launch and Beyond (DSCO, $2.38)

Investment Thesis
We are now nearing the long awaited launch of Surfaxin. During the recent conference call on results for 4Q,…
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InSite Vision: Positive Phase III Trial Results for BromSite Reduces Much of Downside Risk in the Stock (INSV.OB, $0.30)

BromSite Results are Strikingly Positive in First Phase III Trial
InSite Vision (INSV.OB) just announced top-line results from its first phase…
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NovaBay: Topline Data from Two Phase IIb Trials Presents an Asymmetric Investment Opportunity in 2013 (NBY, $1.24)

Introduction
NovaBay (NBY) is focused on the development of novel anti-microbial products that are topically applied as gels, liquid solutions and…
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Trius: Topline Data of Second Phase III Trial of Tedizolid is Eminent (TSRX, $6.76)

Investment Summary and Conclusion

I began recommending Trius (TSRX) with an initiation of coverage report that was published in May of…
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Cadence: Potential Near Term Catalyst for the Stock (CADX, $5.34)

Investment Thesis

I continue with my buy recommendation on Cadence Pharmaceuticals (CADX). I believe that there is a high probability for…
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Northwest Biotherapeutics: My Rationale for Having a Buy Recommendation (NWBO; $3.29)

Crossing Swords
Adam Feuerstein of The Street.com and I crossed swords after I wrote an article in response to a very…
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Northwest Biotherapeutics: A Critique of Adam Feuerstein of TheStreet's Recent Analysis (NWBO, $3.50)

Purpose of this Report
I have undertaken a point by point examination of a negative blog on Northwest Biotherapeutics (NWBO) by…
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Transcept: The Prescription Trend Watch for Intermezzo is On (TSPT, $6.63)

Introduction
Over the last year, I have written seven articles on Transcept (TSPT) and if you would like to have a…
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Discovery Laboratories: Innovative Financing is a Catalyst to Buy the Stock (DSCO, $2.16)

Investment Perspective
Discovery's (DSCO) stock has languished since it announced before the opening on October 24, 2012 that it was delaying…
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Athersys: The Coming Year Will Define Its Adult Stem Cell Product MultiStem (ATHX, $1.63)

Investment Perspective
This is my initial report on Athersys (ATHX) and its adult stem cell therapy product MultiStem. There are important…
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Sangamo: Paradigm Shifting Approach to Gene Altering Leads to Unique Product Opportunities (SGMO, $9.56)

I have followed the progress of Sangamo for over seven years. I listened to a presentation by Edward Lanphier, CEO…
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A.P. Pharma: PDUFA Date on APF530 Looms and I Am a Buyer (APPA.OB, $0.70)

Investment Opinion and Background
I initiated coverage of A.P. Pharma (APPA.OB) in April of 2012 with a Buy. I am anticipating…
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MELA Sciences: In This Put Up or Shut Up Year, I Think the Company Will Succeed with its Launch of MelaFind (MELA, $1.70)

MelaFind
MELA Sciences (MELA) is in the early stage of rolling out MelaFind, an FDA approved handheld optical scanning device for…
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Trius: Why Last Friday’s Equity Offering is good for the Stock (TSRX, $4.90)

Investment Opinion

Trius (TSRX) completed an equity offering on Friday January 19 in which it sold 6.3 million shares at $4.465.…
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Transcept: Purdue Fires Big Marketing Guns and FDA Issues Insomnia Drug Guidelines That Help Intermezzo (TSPT, $5.72)

Investment Opinion
The launch of Intermezzo has been disappointing to investors thus far. Now, Transcept's (TSPT) marketing partner, Purdue Pharmaceuticals, is…
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This Could Be the Coming Out Year for Inovio (INO, $0.72)

I had the opportunity to meet with some of Inovio's (INO) management team- Joseph Kim (Chief Executive Officer), Peter Kies…
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Northwest Biotherapeutics: Transformed from an Ugly Duckling Bulletin Board Company to a Promising NASDAQ Company (NWBO, $3.20)

Investment Update
In my July 19, 2012 report Northwest Biotherapeutics' DCVax Cancer Vaccines May Be a Game Changer in Cancer Therapy,…
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Trius Therapeutics: In an About Face, Congress is Helping Biotech Companies That Are Developing Antibiotics (TSRX, $5.54)

Investment Opinion
In this report, I present my hypothesis as to why I believe that antibiotics development is in the rapid…
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Cadence Pharmaceuticals: Sentiment is Shifting from Bearish to Bullish (CADX, $4.90)

Investment Perspective and Opinion
I continue with my buy recommendation on Cadence Pharmaceuticals.
Cadence introduced its first and only product, the hospital…
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InSite Vision: Upcoming Topline Results from Clinical Trials Presents a Buying Opportunity (INSV.OB, $0.34)

Investment Overview and Opinion
In the first half of 2013, InSite Vision (INSV.OB) will release significant topline data from two phase…
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Discovery Laboratories: Disappointment with the Delay in the Surfaxin Launch Has Created a Buying Opportunity (DSCO, $2.24)

Introduction
I had the opportunity to meet with the management of Discovery Laboratories (DSCO) recently and focused on several issues:


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OncoSec Medical Initiation of Coverage

Introduction
OncoSec Medical is an emerging immunotherapy and drug delivery company with unique and interesting products and encouraging clinical data. Those…
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Repligen: Initiating Coverage with a Buy (RGEN, Buy, $6.13)

Investment Opinion

Repligen (RGEN) has gone through a metamorphosis that has dramatically changed its business model and investment outlook. For years,…
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NovaBay Swings for the Fences with NVC-422 Trial In Viral Conjunctivitis

Investment Thesis
Although NovaBay is a small company as judged by its $43 million market capitalization, it is complex to analyze.…
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Initiating Coverage of Neuralstem with a Buy (CUR, $0.92)

Product Development Overview
This report provides an introduction to stem cells and the cells that comprise the central nervous system. Basic…
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Focusing on the Impetigo Indication for NVC-422 (NBY, $1.29)

Investment Thesis
Although NovaBay(NBY) is a small company as judged by its $37 million market capitalization, it is complex to analyze.…
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NovaBay's Robust Clinical Pipeline Approaches Critical Clinical Trial Results in 2013

Investment Thesis
NovaBay has just received approval in the US for its first product NeutroPhase and will be commercializing it throughout…
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Settlement Between Pfizer and Teva on Generic Zyvox is a Significant Positive for Trius Therapeutics

The Issue
On May 31, 2012, Pfizer Inc. (PFE) and Teva (TEVA reached a settlement that licenses to Teva a generic…
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Northwest Biotherapeutics and ImmunoCellular Therapeutics Can Both Be Winners with their Cancer Vaccines (NWBOD, $5.50)

Investment Perspective
I think that some investors are incorrectly viewing the investment outlook for Northwest Biotherapeutics and ImmunoCellular Technologies (IMUC.OB). Both…
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Recently Added Board Member Brings Great Expertise to the Potential Launch of APF530 (APPA, $0.64)

Investment Thesis and Price Target
I initiated coverage of A.P. Pharma (APPA.OB) with a buy at $0.42 per share on April…
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Confidence for Success of Ofirmev Launch is Bolstered by Very Strong August Results; Buy is Reiterated (CADX; $4.07)

Ofirmev Sales Are on a Strong Growth Track
Cadence just reported a strong increase in sequential vial sales of Ofirmev; they…
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Hitting Major Milestones is Driving InSite's Price (INSV.OB, $0.40)

Investment Summary
InSite Vision (INSV.OB) has an aggressive and capable management team that continues to impressively execute on its game plan,…
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Antares' Pipeline is Bursting with New Products; Vibex MTX is the Star (ATRS)

Investment Opinion
I am reiterating my Buy recommendation on Antares which was initiated on December 6, 2011 at a price of…
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Cadence Strengthens on Positive News Flow

Recent Positive News
Cadence's stock has strengthened recently on the basis of two new pieces of information. The first deals with…
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An Update on Trius Therapeutics’ Tedizolid; a Potential Blockbuster for Treating MRSA Infections (TSRX, $5.41)

Investment Recommendation
I am reiterating my buy recommendation on Trius Therapeutics (NASDAQ: TSRX). This note is follow-up to a 35 page…
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Johnson & Johnson: A Buy and Core Holding for the Long Haul (JNJ, $68.35)

Investment Overview
Johnson & Johnson (JNJ) is a colossus among health care companies with an estimated $68 billion of revenues in…
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Cadence Pharmaceuticals: Ofirmev Launch Has Gained Traction; Reiterate Buy

Investment Overview and Opinion
I reiterate my Buy recommendation on Cadence. The Ofirmev launch has now gained traction as just reported…
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Bristol-Myers Squibb: Side Effect Issue with Hepatitis C Drug Creates a Buying Opportunity (BMY, $32.55)

Side Effect Issue Leads to Sharp Price Drop
Bristol-Myers disclosed on August 1, 2012 that it has suspended a phase II…
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Bristol-Myers Squibb: Best Positioned for Growth of the Four Big US Pharma Companies

Bristol-Myers (BMY), Eli Lilly (LLY), Merck (MRK) and Pfizer (PFE) were out of favor for many years based on concerns…
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Northwest Biotherapeutics’ DCVax Cancer Vaccines May Be a Game Changer In Cancer Therapy (NWBO, $0.22)

Northwest Biotherapeutics' DC Vax Cancer Vaccine May Be a Game Changer
In Cancer Therapy

Report Outline
Investment Thesis and Opinion
Introduction
Phase I Trial…
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Spectrum Pharmaceuticals: The Bull and the Bear Case (SPPI, $15.72)

Reason for Report
At the request of some subscribers to my website, I have been asked to take a look at…
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Bristol-Myers Squibb: Acquisition of Amylin is a Mild Posiitve (BMY, $35.89)

Investment Opinion
I prefer growth through internal product development over growth through acquisition. It is the product pipeline that drives my…
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A.P. Pharma: Ondansetron’s Link to QT Interval Prolongation is a Huge Positive for APF530 (APPA, $0.68)

Investment Thesis
The FDA issued a safety communication on June 29, 2012 further advising physicians on the link of ondansetron (Zofran)…
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Cadence Pharmaceuticals: Ofirmev Sales are Likely to Surprise on the Upside in the Second Quarter and Fears of Generic Competition are Overblown (CADX; $2.91)

Investment Summary and Thesis
In my report of May 31, 2012, I stated that management guidance for Ofirmev sales of $10.0…
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InSite Vision: Initiation of Coverage on Promising Late Stage Ophthalmology Company (INSV, $0.30)

Report Overview
The core technology of InSite Vision is its DuraSite delivery system that delivers drugs more effectively to the eye.…
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Discovery Laboratories: Surfaxin Is Superior to Animal Surfactants (DSCO, $2.74)

Purpose of Report
Discovery Laboratories (DSCO) held a quarterly conference call on May 3 to update investors on the pending launch…
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Cadence Pharmaceuticals: The Ofirmev Launch Has Gained Traction (CADX, $2.72)

Cadence Pharmaceuticals: The Ofirmev Launch is Gaining Traction (CADX, $xx)
Investment Thesis I believe that Ofirmev, an intravenous formulation of acetaminophen,…
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Trius Therapeutics' Tedizolid has Blockbuster Potential for MRSA Infections (TSRX, $5.05)

Introduction Trius Therapeutics is in late stage clinical development of its new antibiotic, tedizolid, for treatment of MRSA infections that…
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Antares: Settlement of Litigation on EpiPen is a Positive (AIS, $3.08)

Conclusion
I believe that the settlement on the EpiPen litigation is a positive for Antares. It pushes the launch date for…
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The Rationale Behind Dendritic Cell-Based Cancer Vaccines and How They are Manufactured (NWBO.OB, $0.22)

Dendritic Cell-Based Cancer Vaccines Could Be a Major Advance
In October of 2011, Dr. Ralph Steinman was post-humously awarded one-half of…
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Savient: Recommending A Switch Into Discovery Laboraratories (SVNT, $2.31)

I have decided to go the sidelines on Savient (current price of $2.31) and I am recommending a switch into…
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A.P. Pharma: Initiating Coverage with a Buy (APPA.OB, $0.42)

Key Investment Conclusions
In this report, I have made projections for sales, earnings and cash flow for A.P. Pharma (APPA.OB) through…
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The Launch of Transcept's Intermezzo by Purdue Has Begun (TSPT, $10.92)

Investment Opinion and Overview
Now is the moment of truth for Transcept (TSPT) as the launch of Intermezzo has begun. I…
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Levadex Receives Complete Response Letter, What Does This Mean for the Stock? (MAPP, $16.44)

Summary
I think that it is a question of when and not if Levadex is approved. The complete response letter or…
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Levadex Has a Good Chance for Approval on its March 26th PDUFA Date (MAPP, $17.09)

Investment Opinion, In Brief
The PDUFA date for Levadex, MAP Pharmaceutical's lead product, is looming on March 26, 2012. I believe…
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There are Good Reasons to Remain Positive on Dendreon (DNDN, $11.14)

When I was in high school I played the trombone in the marching band. I could never stay in step,…
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Generic Challenge to Pfizer's EpiPen by Teva and Antares (AIS, $2.70)

EpiPen is a self-administered injection of epinephrine used to avert anaphylactic shock following a severe allergic reaction, as with a…
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Equity Offering Provides Discovery Laboratories Much Needed Financial Strength (DSCO, $2.81)

Report Summary
With a number of cash infusions from a public offering, an ATM drawdown and warrant exercises, Discovery Laboratories (DSCO)…
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Surfaxin Should Be Approved on its March 6th PDUFA Date (DSCO, $2.82)

Investment Thesis and Valuation
The transformation of a biotechnology company from development stage to commercial can be the catalyst for a…
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Cadence: Product Recall Doesn't Alter Sales Projections (CADX, $4.19)

I was somewhat alarmed to see a press release entitled “Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV®…
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Vibex MTX is the Most Exciting Component of the Antares Investment Outlook (AIS, $2.74)

Investment Thesis
I initiated coverage of Antares (AIS) on December 8, 2011 with a buy rating. Important factors driving my recommendation…
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John Johnson Resigns as CEO, After Thinking It Over, I Continue with My Buy Recommendation (SVNT, $2.27)

The decision of John Johnson to go to Dendreon as CEO and Chairman after only one year at the helm…
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Dendreon Turns Reins Over to New CEO (DNDN, $14.18)

Key Points
Dendreon has made a sweeping change in management by bringing in John Johnson, who was serving as a board…
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Quarterly Sales Show That Both Provenge and Zytiga Are Doing Very Well (DNDN, $13.58)

Investment Conclusion
Both Zytiga and Provenge have had very successful launches in the US. Fears that Zytiga would negatively impact sales…
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The Promise of the Antares Pipeline is the Basis of my Buy Recommendation (AIS, $2.40)

Investment Opinion
The failure of the Libi-Gel trial rocked the stock of Antares (AIS) and caused it to drop from around…
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Expanding on Clinical Trials of CPP-109 in Cocaine Addiction and Pre-Clinical Studies of CPP-115 (CPRX, $1.14)

Purpose of Report
I recently initiated coverage of Catalyst Pharmaceutical Partners (CPRX). This report is a follow-on to that report which…
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Many Investors Rate Ofirmev Launch a Failure-Not So Fast (CADX, $4.06)

Investment Opinion
Many or most investors have written off the launch of Ofirmev as either disappointing or an outright failure. I…
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Now That Pharmasset and Achillion Have Received Takeover Bids; Is Achillion Next? (ACHN, $9.72)

Following the announcement that Gilead was proposing to acquire Pharmasset (VRUS), I postulated in a note written on November 11,…
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Investors' Concern About Launch of Intermezzo Weighs on the Stock and Creates a Buying Opportunity (TSPT, $8.21)

Investment View
I believe that Transcept’s (TSPT) Intermezzo is an important new drug for insomnia and will be a commercial success.…
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Initiating Coverage Based on Interest in CPP-109 for Treating Cocaine Addiction (CPRX,$1.18)

Company Overview
The US Department of Health and Human Services estimates that there are about 1 million Americans addicted to cocaine…
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Antares Is Initated As A Buy Based On Broad, Promising Pipeline (AIS, $2.59)

Investment Opinion
I am recommending purchase of Antares (AIS) at the current level of $2.59. My 2015 price target is $6.70.…
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Initiating Coverage of MAP Pharmaceuticals with A Buy Based On Potential for Levadex (MAPP, $13.35)

Investment Opinion
Map Pharmaceuticals is poised to introduce its first commercial product, Levadex (inhaled dihydroergotamine) that is indicated for treating acute…
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Libi-Gel Phase III Trial Results Should Be Released Shortly (AIS, $2.73)

Investment Overview
One of the eleven products that Antares has in late stage development is Libi-Gel for treating female sexual dysfunction…
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Collaboration with Teva on Self-Injected Drugs Is the Major Driver of the Investment Thesis (AIS, $2.68)

Investment Thesis
In my initial report on Antares, I recommended purchase based importantly on the potential for its self-injection technology. One…
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Approval of Anturol Is Significant Positive (AIS, $2.68)

Anturol Approval is A Major Positive

Recently, I wrote a note about Anturol discussing its therapeutic profile and the commercialization agreement…
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Anturol's December 8th PDUFA Date Is Looming (AIS, $2.77)

Introduction
I recently began coverage of Antares with a buy. The basis of my recommendation was the exceptional pipeline of drugs…
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How Big is the Chronic Refractory Gout Market Addressed by Krysrexxa? (SVNT, $2.28)

Introduction
The size of the chronic refractory gout market that Krystexxa targets have been a concern to investors and some believe…
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Initiating Coverage of Savient Pharmaceuticals with a Buy: Initial Launch of Krystexxa Has Been Disappointing but I Believe That This is a Breakrhrough Drug with Great Potential (SVNT, $2.35)

Investment Opinion
I am recommending purchase of Savient Pharmaceuticals at the current price of $2.35. My recommendation is based on the…
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Are Investors So Pessimistic On Provenge That They Are Ignoring Some Positive Trends (DNDN, $8.78)

Key Investment Issues
Investment sentiment on Dendreon has deteriorated so much that investors seem to be only focusing on what has…
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Achillion Could Be On Big Pharma's Acquisition List (ACHN, $6.00)

Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11…
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Will Inhibitex Be The Next Big Acquisition in the HCV Space ? (INHX, $10.69)

Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11…
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Gilead Makes Bid for Pharmasset: Could Achillion Be Next in Big Pharma's Acquisition Gun Sights (ACHN, $6.00)

Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11…
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Gilead's Acquisiton of Pharmasset Is Expensive But Great Strategic Move (GILD, $35.57)

Gilead (GILD) is certainly paying up for Pharmasset with its offer to buy the company at $137 per share ($11…
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Physician Survey on Provenge is Encouraging, Upgrading Dendreon to Buy (DNDN, $6.55))

Introduction
Over the last few months, I have been speaking to physicians and researchers who are using and studying Provenge. Based…
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Cubist Makes Attractive Takeover Bid for Adolor (ADLR, $1.91)

Investment View of the Proposed Acquisition
Cubist announced today that it had signed a definitive agreement to acquire Adolor.
Adolor has been…
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Santarus Jumps Last Hurdle for Submitting NDA on Key Blockbuster Drug Budesonide MMX (SNTS, $2.79)

Investment Opinion and Overview
For those of you who read my recent reports on Santarus, you will recall that I believe…
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Management Guidance On Issues Key to Provenge's Outlook (DNDN, $9.00)

Investment Opinion
In the aftermath of the 70% meltdown in the price of Dendreon stock caused by sharp lowering in expected…
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An In-Depth Look at Santarus as it Develops a Promising Pipeline to Offset Patent Challenges to Existing Products (SNTS, $3.14)

Investment Overview
Santarus was founded to commercialize Zegerid for the treatment of gastrointestinal reflux disease (GERD) and ulcers. It competed in…
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Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review (TSPT, $6.63)

Resubmission of Intermezzo NDA
Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA…
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Check with Adolor Management on Entereg Marketing Transition and Progress of Partnering Discussions on ADL 5945 (ADLR, $2.05)

Investment Thesis
I upgraded Adolor to a BUY after the company announced that it had reacquired all rights to Entereg from…
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Budesonide MMX's Potential in Ulcerative Colitis (SNTS, $3.18)

Investment Thesis
This report focuses on the ulcerative colitis market and particularly on budesonide MMX, an important new drug being developed…
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FDA Advisory Committee Recommendation for Approval of Xarelto Bodes Well for Approval of Eliquis (apixaban)

The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in…
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FDA Advisory Committee Goes Against FDA and Recommends Approval of Xarelto

The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in…
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Rhucin in the Hereditary Angioedema Market Can Be A Meaningful New Product for Santarus (SNTS, $3.14)

Investment Thesis
This report is intended to highlight the potential for four current products and one in development for the treatment…
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Kalbitor Prospects Are Not Good in Hereditary Angioedma (DYAX, $1.61)

Investment Thesis
This report is intended to highlight the potential for four current products and one in development for the treatment…
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Firazyr Has Excellent Potential in the Hereditary Angioedema Market (SHPGY, $96.48)

Investment Thesis
This report is intended to highlight the potential for four current products and one in development for the treatment…
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ViroPharma's Cinryze is Well Positioned for Growth in the Hereditary Angioedema Market (VPHM, $18.99)

Investment Thesis
This report is intended to highlight the potential for four current products and one in development for the treatment…
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Xarelto's Problems are Eliquis' Opportunities (BMY. $29.90)

Investment Opinion
I have been on the fence in deciding whether to upgrade Bristol-Myers (BMY) to a Buy. The issues now…
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How Effective is Provenge (DNDN, $12.15)

A criticism that is heard over and over from lay people is that Provenge provides only marginal benefit with an…
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Initiation of Coverage of ImmunoCellular Therapeutics (IMUC.OB)

Investment Overview
ImmunoCellular Therapeutics (IMUC.OB) lead product ICT-107 is a dendritic cell vaccine for treating glioblastoma multiforme (GBM). Its technology is…
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An Introduction to Sangamo's Gene Altering Technology (SGMO, $4.50)

Sangamo: An Introduction to Its Gene Altering Technology
 
Investment Perspective
This report tries to present the technology of Sangamo in terms that…
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Orexigen Revisited: Chances for Contrave Approval Seem Slim (OREX, $1.37)

Orexigen reported second quarter results on August 8, 2011 in a press release, but did not hold a conference call.…
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Phase II Data for ADL 5945 in Opiod Induced Constipation is Excellent (ADLR, $2.23)

On a first quick review of the data from the phase II trial of ADL 5945 in chronic non-cancer pain…
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Prospects for Entereg May Justify $4.50 Price Target for 2013 (ADLR, $2.20)

Overview
I recommended the purchase of Adolor in a report issued on June 19. This followed my initiation report of February…
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Previewing Dendreon's 2Q Results to be Reported on August 3: It's All About Provenge (DNDN, $36.13)

Dendreon is scheduled to report second quarter results on August 3 and will hold a conference call at 4:30 to…
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New Product Potential is Outstanding But Patent Cliff is Looming (BMY, $29.28)

Investment Position
My position on BMY is that patient investors can buy the stock for the dividend yield and wait for…
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Eliquis Could Be A Blockbuster (BMY, $29.46)

Introduction and Purpose of this Report
I believe that the anti-coagulant drug market is poised to become the next blockbuster category…
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Xarelto Could Be Another Blockbuster (JNJ, $66.64)

Introduction and Purpose of this Report
I believe that the anti-coagulant drug market is poised to become the next blockbuster category…
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Second Quarter Report Was Modestly Disappointing But New Pharmaceutical Products are the Key to the Investment Outlook (JNJ, $66.26)

Investment Thesis
There was modest investor disappointment with Johnson & Johnson’s second quarter results reported on July 19, 2011. The stock…
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Five Questions Posed by the FDA to Its Advisory Committee on Dapagliflozin (BMY, $28.96)

Overview of Five Briefing Questions Posed by FDA on Dapagliflozin
On Friday, July 15, 2011 the FDA published on its website…
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Dapagliflozin's Date with the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (BMY, $29.17)

Overview and Investment Thesis
The strong Bristol-Myers pipeline story is key to the investment thesis and is driven by three potential…
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Intermezzo is Likely to be Approved on its July 14, 2011 PDUFA Date; Then What (TSPT, $7.98)

Investment Thesis
Transcept’s new drug for insomnia, Intermezzo, received a Complete Response Letter on October 26, 2009 in which the FDA…
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ANDA Filing Aganist Ofirmev Is Not Unduly Concerning (CADX, $9.25)

Investment Opinion
I believe that the Ofirmev approval is a game changer that can propel Cadence into a successful, medium tier,…
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Provenge Receives Final CMS Reimbursement Approval (DNDN, $41.40)

CMS Approval Removes Investor Concern
CMS issued its final national coverage decision on Provenge yesterday and confirmed the preliminary decision that…
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Yervoy Was A Star at American Society of Oncology: Commercial Potential Is Enormous (BMY, $29.15)

Investment Overview
I have previously written about Bristol-Myers Squibb (BMY) as having possibly the best pipeline among the major pharmaceutical firms.…
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The Bull and Bear Case for Anadys (ANDS, $1.00)

The investment thesis for Anadys is almost totally based on the prospects for its lead drug, ANA 598, which is…
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Upgrading to Buy Based On Regaining Glaxo's Rights in Entereg (ADLR, $1.65)

Investment Thesis
Adolor has gained back Glaxo’s rights to Entereg (alvimopan) in a transaction that I regard as a highly positive,…
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Implications Stemming From FDA Requirement for Extremely Large Cardiovascular Outcomes Study for Orexigen's Contrave (VVUS, $8.00)

Stock Opinion
The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17,…
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Implications for Lorquess From FDA Request for Extremely Large Cardiovascular Outcomes Study for Orexigen's Contrave (ARNA, $1.31)

Stock Opinion
The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17,…
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Orexigen Receives Crushing News That FDA Will Require Extremely Large Cardiovascular Outcomes Study In Order for Contrave To Gain Approval (OREX, $1.83)

Stock Opinion
The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17,…
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Thoughts on Recent Poor Stock Performance (ANDS, $1.09)

Meeting With CEO Steve Worland

Anadys' CEO Steve Worland was in town for the Piper Jaffrey conference along with Investor Relations…
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Investment Negatives and Positives (ANDS, $2.06)

I had a telephone conversation with CEO Steve Worland to discuss the negatives and positives for Anadys over the next…
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Initial Meeting with Anadys' CEO Steve Worland (ANDS, $2.33)

I met with CEO Steve Worland and IR contact Amy Conrad at their offices in San Diego. This was my…
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Update on Anadys' Lead Drug, ANA-598 for Hepatitis C (ANDS, $2.06)

I had a phone conversation with CEO Steve Worland in which he gave me an update on the company’s lead…
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Transcept Releases Results of Highway Driving Study for Intermezzo and Plans to Re-Submit NDA in the First Quarter of 2011 (TSPT, $6.61)

Transcept believes that the results of the highway driving study of Intermezzo reasonably answer the concerns of the FDA that…
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Company Reports Success in Four Phase III Trials (OREX, $4.23)

Orexigen has just reported success in four phase III trials for Contrave in obesity.

Contrave Overview
The key efficacy measure in these…
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Going Over the Outlook with the New CEO, Mike Narachi (OREX, $5.32)

I have met numerous times with CFO, Graham Cooper. This was an opportunity to meet with the new CEO, Michael…
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Thoughts on Upcoming Advisory Meeting on Contrave (OREX, $5.40)

On December 3, 2010, an FDA advisory panel will review the NDA submitted by Orexigen Therapeutics for its new anti-obesity…
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FDA Advisory Committee Vote on Lorcaserin is Negative (ARNA, $3.74)

Yesterday, the FDA advisory committee voted 9 to 5 against approval of Lorcaserin. I listened to the day long proceedings…
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Trying to Define Path Forward for Lorcaserin with FDA (ARNA,$1.49)

Arena held a conference call on March 11, 2011 to update investors on the possible regulatory path forward for lorcaserin.…
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Initial Buy Recommendation (JNJ, $62.69)

I believe that Johnson & Johnson will experience an acceleration in earnings based on an outstanding pipeline of new drugs.…
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Preview of 1Q, 2011 (DNDN, $41.78)

Dendreon will be hosting its first quarter conference call on May 2, 2011 at 4:30 EST. I anticipate that Provenge…
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CMS May Issue Provenge Reimbursement Decision on March 31 (DNDN, $32.92)

CMS may issue on March 31, its draft guidance for the national coverage analysis of Provenge for use in asymptomatic…
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Building a New Company on Zegerid's Ashes (SNTS, $2.24)

Investors are evaluating the impact on the earnings of Santarus following the recent launch of a generic to its key…
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Zegerid's Patents Are Ruled Invalid (SNTS, $5.36)

On April 14th, Santarus announced that a Court has ruled that five patents covering Santarus’ ZEGERID® (omeprazole/sodium bicarbonate) prescription products…
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Par Launches Generic Zegerid At Risk (SNTS, $4.55)

Par Pharmaceutical’s launched at risk a its generic version of Zegerid capsules, Santarus responded by launching its own authorized generic,…
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Details on Par's Challenge to Zegerid Parents (SNTS, $3.30)

Santarus has just anounced that Par has filed a paragraph IV challenge to Zegerid's patents. Depending on the outcome there…
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Update on Santarus (SNTS, $1.78)

Overview
I recently met with Debbie Crawford, Chief Financial Officer, and Martha Hough, Head of Investor Relations. I continue to feel…
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Initiation Report (MDVN, $17.09)

I am initiating coverage of Medivation based on my interest in their new drug for prostate cancer MDV 3100, which…
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Highlights of 1Q, 2011 (DNDN, $42.81)

Summary and Stock Opinion
The 1Q sales of Provenge were exactly in line with my estimate of $28 million. There was…
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Manufacturing and Logistics Issues (DNDN, $32.57)

Dendreon intends to increase manufactruing capacity in 2011 to ten times the level of December 31, 2010. This should be…
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Initiating Coverage With A Buy (DNDN, $34.98)

I am recommending puchase of Dendreon. The investment thesis is almost entirely dependent on the success of Provenge.
 
Summary and Overview
Dendreon…
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Provenge's European Opportunity (DNDN, $33.59)

The European Union represents a large pool of hormone resistant prostate cancer patients and could be a commercial opportunity for…
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Interview with Two Key Opinion Leaders In Prostate Cancer About Provenge (DNDN, $35.89)

I spoke with two key opinion prostate cancer opinion leaders about their views on the potential for Dendreon's Provenge.
 
Investment Issues…
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2011 Is The Crucial Year for Provenge and Dendreon (DNDN, $34.59)

Summary and Overview
Dendreon began the marketing of Provenge, its cancer vaccine for prostate cancer in May of 2010. Enthusiasm following…
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Telaprevir Has Significant Therapeutic and Blockbuster Sales Potential for Hepatitis C (JNJ, $64.95)

The landscape for treating hepatitis C virus is on the verge of dramatic change due to the development of new…
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Abiraterone is Significant Advance in Prostate Cancer Treatment (JNJ, $64.11)

I recently recommended purchase of Johnson & Johnson (JNJ) in a report on April 24, 2010 called Johnson & Johnson…
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An Analysis of 4Q, 2010 and A Look Forward (BDSI, $3.41)

BioDelivery Sciences is making steady progress in advancing its pipeline and also has set the stage for a pickup in…
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Initial Report (BDSI, $3.50)

I have just recently begun to follow BioDelivery Sciences International (BDSI) and I am encouraged by the research that I…
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Initial Report (CRIS, $1.92)

Summary and Overview
Curis has demonstrated impressive drug development capability in the oncology space. However, it has followed a policy of…
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1Q, 2011 Overview: Ofirmev is Experiencing Exceptionally Good Formulary Acceptance (CADX, $7.72)

I continue to recommend purchase of Cadence based on trends seen in the 1Q, 2011 period. The details of my…
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Initial Report: Ofirmev Potential is the Basis for a Buy Recommendation (CADX, $7.10)

I am recommending purchase of Cadence Pharmaceuticals based on the promise of its recently launched intravenous analgesic, Ofirmev.
Stock Opinion
Cadence Pharmaceuticals…
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Ipilimumab's March 26 PDUFA Date Is Looming (BMY, $26.00)

The PDUFA date for ipilimumab is coming up on March 26th. This is an important component of BMY's outstanding pipeline.…
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Ipilimumab's Approved Indications Exceed Expectations (BMY, $26.93)

I was expecting approval of ipilimumab for patients who had failed prior therapy. I was surprised that the FDA also…
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Initiating With Buy: Weighing an Excellent New Product Outlook Against the Pending Patent Cliff (BMY, $25

I think that Bristol-Myers Squibb has one of the most attractive drug pipelines of the big pharma companies. Although it…
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Initiation Report on a Cheap Lumbering Stock (PFE, $20.78)

Pfizer is entering a patent cliff period in which sales will decline over the next two years. The drug pipleline…
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Onsite Meeting with Anadys' CEO Steve Worland (ANDS, $1.77)

I met with Anadys’ CEO Steve Worland and IR contact Amy Conrad at their offices in San Diego for an…
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Analysis of Adolor's 1Q, 2011 and A Look Forward (ADLR, $1.39)

Entereg Results in the Quarter Were Excellent
Entereg achieved sales of $7.5 million which was an increase of 41% from 1Q,…
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Initial Report on Adolor (ADLR, $1.38)

Adolor as a Stock

While I am currently neutral on Adolor, it is a stock that I am watching closely. To…
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Hopes for Rivaroxaban Are Dashed (JNJ, $65.00)

Investment Opinion
The FDA problems encountered with rivaroxaban are a significant, but not crushing negative for the investment thesis of Johnson…
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