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Expert Financial Analysis and Reporting

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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Update on Currently Recommended Stocks of SmithOnStocks.com

Report Overview

I periodically update my recommendations and that is the objective of this report. I also spend some time on…
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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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Novartis Releases Three Month Interim Data for JULIET Trial of CTL-019 in r/r DLBCL

Key Points:

Comparison of three month data for CTL-019 in the JULIET trial with  Axi-Cel in ZUMA-1 indicates that safety…
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FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Neutral, $80.25) and Cryoport (CYRX, Buy, $3.89)

The FDA has announced that there will be an AdCom meeting for Novartis’ CTL-019 for the treatment of pediatric r/r…
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Northwest Biotheraputics to Make Presentation at ASCO Today Monday June 5, 2017

Northwest issued a press release announcing a presentation at ASCO today by the Company’s Chief Technical Officer, Dr. Marnix Bosch.…
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Key Investment Considerations Relating to Much Anticipated CAR-T Product Launches By Kite and Novartis Later This Year

Investment Conclusions:

Cryoport: My recommended best way to invest in CAR-T launches (CYRX, Buy, $3.60)
Kite Pharma: Seems priced for…
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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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Cytokinetics: Comments on the Upside Move Today (CYTK, Buy, $12.90)

Cytokinetics is up $1.15 or 10% to $12.90 in a poor market environment. The only news is that the Company…
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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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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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SmithOnStocks Investment Recommendations Summarized; September 12, 2016

PURPOSE OF REPORT

Biotechnology investing is characterized by long periods of steady, sometimes frightening declines followed by periods of euphoria. We…
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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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Bristol-Myers Squibb: Checkmate-026 Trial Fails to Reach Primary Endpoint (BMY, $62.85); A Buying Opportunity

Perspective

Bristol-Myers Squibb Company announced today that Opdivo had failed to reach its primary endpoint of progression free survival in the…
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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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Updates on My Investment Opinion for 15 Stocks I Follow Closely

Report Overview

This blog gives a quick update on my thinking on the 15 stocks which I cover. In most cases,…
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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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Northwest Biotherapeutics (NWBO): Some Thoughts about the Appointment of Two New Board Members

Purpose of the Report

Northwest Biotherapeutics announced on January 25 that it is adding two new members to its current…
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My Current Thoughts on 13 Stocks I Cover and the Investment Outlook for the Market

Purpose of This Report
This report is being written at a time of panic in the market in which a sharp…
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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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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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