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Expert Financial Analysis and Reporting

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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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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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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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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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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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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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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Martin Shkreli Arrested; This Could Be A Major Catalyst for Small Biotechnology Stocks

Bloomberg reported that Martin Shkreli was arrested at his home this morning (December 17) on charges of securities fraud; his lawyer…
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Why Biotechnology Investing is So Difficult: Cytokinetics is a Case Study (free article)

Overview

I just finished publishing a detailed article for subscribers to my website detailing my view that Cytokinetics offers asymmetric upside potential.…
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KaloBios: The Fascinating Story of the Takeover of the Company by Martin Shkreli and His Hedge Fund Buddies (KBIO, $18.25, I would not touch this stock)

Investment Thesis and Overview

KaloBios (KBIO) announced on November 13 that it was ceasing operations and had engaged a restructuring firm…
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Valeant Pharmaceuticals: What A Sordid Story (VRX, $93.77)

My View on Valeant

I have been asked about my feelings on Valeant. I would start out by saying that I…
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Review of SmithOnStocks Recommendations; August 17, 2015

Purpose of Report

I am leaving on vacation and will be back on August 27, 2015; you won’t hear from me…
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Comments on Agenus, ImmunoCellular, Discovery Laboratories, Neuralstem, Kite and Juno

SmithOnStocks Mailbox
 Comments on Agenus, ImmunoCellular, Discovery Laboratories, Neuralstem, Kite and Juno
About the Mailbox:

My mailbox comments are brief notes on stocks…
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Implication of the Juno Celgene Deal for Emerging Immuno-Oncology Biotechnology Stocks in General and Northwest Biotherapeutics in Particular

The Terms of the Juno Celgene Deal

Celgene and Juno announced a ten year collaboration for drug development using CAR-T therapy…
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Illegal Naked Short Selling Appears to Lie at the Heart of an Extensive Stock Manipulation Scheme

Investment Consequences of Naked Shorting

Only a motivated enforcement agency with subpoena power and an accompanying powerful enforcement infrastructure can prove…
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Comments on Agenus and Antares

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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Comments on Antares, Kite Pharma and Northwest Biotherapeutics

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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Comments on Agenus, Neuralstem and Celldex

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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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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Comments on Antares, Agenus, Cytokinetics, Discovery Laboratories and ZS Pharma

SmithOnStocks Mailbox
April 28, 2015
A Quick Take on Recent Events
If you have a question for the mailbox, contact me.
Purpose of this…
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Effective Treatment of Hyperkalemia Promises to be a Multi-billion Opportunity

Key Points

There are no effective treatment options for long term treatment of hyperkalemia (high potassium levels).
My research suggests that the…
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SmithOnStocks Mailbox, January 31 Edition: My Take on News Events Relating to Companies I Follow

Introduction

A number of subscribers have suggested that I write more on recent news events that relate to companies that I…
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Advaxis: A Look at the Dizzying Trading Activity over the Past Month (ADXS, No opinion, $9.70)

Introduction

My approach to my website in the two years I have been publishing is to in-depth research on a limited…
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Northwest Biotherapeutics: Some Thoughts about the Upcoming Presentation by CEO Linda Powers on Monday, January 26th. (NWBO, Buy, $6.28)

Ms. Powers will present at 10:30 AM.
She will then participate in a discussion panel with representatives from Amgen, Roche Diagnostics,…
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Immuno-Oncology Promises to be the Next “Big Thing” In Biotechnology

Immuno-Oncology Promises to be the Next “Big Thing” In Biotechnology
Purpose of the Report

Immuno-oncology has been the hottest area in biotechnology…
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Antares Pharmaceuticals: Highlights of Presentation at JP Morgan Conference (ATRS, $2.36. Buy)

Investment Overview

Antares has hit a somewhat dis-settling stretch as Otrexup prescriptions have recently flattened and the FDA recommended that additional…
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Notes from Neuralstem Presentation at Biotech Showcase Conference, January 13, 2015 (CUR, Buy, $3.09)

Richard Gar, CEO of Neuralstem (CUR), made a presentation at Biotech Showcase Conference in San Francisco on January 13, 2015.…
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Delay in Quick Shot Testosterone Clinical Program is Not a Major Setback for the Stock (ATRS, Buy, $2.53)

Antares sent out a press release today about a new development in the Quick Shot Testosterone phase 3 program. The Company…
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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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Repligen: Revenues for 2014 are Above Expectations and Guidance for 2015 is for Strong Growth (RGEN, Hold/ Buy, $23.84)

Repligen reported preliminary, unaudited revenue of $63-$63.5 million for 2014. Product revenues came in at $60 to $60.5 million which…
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Neuralstem: An Update on Potential Catalysts for 2015 (CUR, Buy, 3.38)

Overview and Investment Thinking

I wrote a report on Neuralstem on August 26, 2014 in which I projected the timing of important…
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Cytokinetics: Takeaways from January 5, 2014 Conference Call (CYTK, Buy, $7.82)

Cytokinetics held a conference call on January 5th in which they added some detail on the collaboration with Astellas on…
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Cytokinetics: With the Stock Up 63% in the Last Seven Trading Days, What Do We Do Now? (CYTK, $8.01, Buy)

The strength followed the announcement of a new collaboration agreement with Astellas on CYTK’s unique skeletal muscle activators program
This added…
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Current Investment Recommendations for Stocks Covered by SmithOnStocks; A Yearend Review

Overview

This has been a tough year for many small emerging biotechnology firms. Many have been in a bear market while…
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Neuralstem: Some Encouraging, But Very Early, Information on Chinese Ischemic Stroke Trial Using NSI-566 Stem Cells (CUR, Buy, $2.59)

Purpose of This Blog

I received this e-mail communication from a SmithOnStocks subscriber who has a good insight into the Chinese…
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Antares: Responding to Two Questions on Teva’s AB Rated Competitor to EpiPen (ATRS, Buy, $2.44)

Purpose of the Blog

I very much appreciate questions and feedback from subscribers to my website. I have had two recent…
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Antares: Highlights of CEO’s Presentation at Piper Jaffray Conference (ATRS, Buy, $2.46)

Overview

I tuned in to the Antares presentation at the Piper Jaffrey conference on December 2, 2014 to listen to what…
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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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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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Weakness in Neuralstem Caused by Seeking Alpha Article Presents a Buying Opportunity (CUR, $2.69, Buy)

This is an updated version of a blog that was published on October 20th.
A Seeking Alpha article on results from…
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Cytokinetics Is Planning for a Phase 3 Trial in 2015 for Tirasemtiv in ALS (CYTK, $3.26, Buy)

Cytokinetics (CYTK) has announced   that it is planning a phase 3 trial for tirasemtiv using sustained vital capacity-SVC- as…
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Discovery Laboratories Has Formed an Important Collaboration with Battelle to Develop Aerosurf (DSCO, Buy, $1.69)

This agreement partners Discovery with a world class medical device developer and meaningfully de-risks development of Aerosurf.
It also gives meaningful…
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Trying To Find Those Technologies and Emerging Biotechnology Companies That Could Be The Big Winners of Coming Decades

 
Purpose of Report
I attended the Rodman conference on September 9th and 10th and listened to 29 company presentations and then…
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My Dialogue with Adam Feuerstein on Northwest Biotherapeutics

Perspective
I think that all investors in Northwest Biotherapeutics (NWBO) would concur that Adam Feuerstein has a vendetta against NWBO and…
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Neuralstem: Investigators are Very Positive on NSI-566 Results in ALS (CUR, Buy, $3.27)

Investment Perspective

The key investigators for the treatment of ALS with Neuralstem’s NSI-566 neural stem cells have been extremely positive in…
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Derma Sciences: Second Quarter Results Were Disappointing; Going From a Buy to a Hold (DSCI, $9.72)

Derma Sciences released second quarter results this morning and this is my quick take. I will have a more detailed…
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My Rebuttal to Richard Pearson's Attack Article on Me Is Now On Seeking Alpha

After a week of effort in trying to post a rebuttal to Richard Pearson's attack article on me, I finally…
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Northwest Biotherapeutics (NWBO, Buy $6.75): Responding to Serious Unsubstantiated Allegations by Richard Pearson

Who Is Richard Pearson?

On July 7, I was the subject of a vicious and libelous article that was published on…
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Cytokinetics: Tirasemtiv May Still Be Successfully Developed in ALS (CYTK, Buy, $4.77)

I think that there is a strong possibility that Cytokinetics (to the surprise of Wall Street) could announce sometime in…
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Antares: More On Paul Wotton’s Departures as CEO (ATRS, Buy, $2.77)

This is a follow-up on Paul Wotton’s decision to leave his position as CEO of Antares (ATRS) to become CEO…
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Antares: Thoughts on the Resignation of the CEO (ATRS, $2.76, Buy)

The resignation of Paul Wotton as CEO of Antares came as a surprise to me and I think most other…
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Northwest Biotherapeutics: Sixteenth Feuerstein Attack on the Company (NWBO, Buy, $8.11)

Adam Feuerstein has just  launched its 16th negative blog on Northwest Biotherapeutics since the beginning of March and this has…
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Neuralstem: Encouraging Phase 1b Data on NSI-189 (CUR, Buy, $4.35, Free content)

On June 17 at the American Society of Clinical Psychopharmacology Neuralstem reported phase 1b data for its small molecule drug…
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Northwest Biotherapeutics: The Perfect Storm May Be Brewing for Short Sellers (NWBO, $7.66, Buy, Free Content)

I wrote on June 12th  that NWBO stockholders may be seeing a changing in the tide of investor opinion. The…
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Discovery Laboratories: A Look at the Surfaxin Launch and the Phase 2a Trial of Aerosurf (DSCO, Buy, $1.79, free content)

Launch of Surfaxin

The launch of Surfaxin has begun and initial results were below expectations causing the Company a few months…
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Northwest Biotherapeutics to Host Conference Call This Afternoon, May 27th (NWBO, Buy, $6.25)

Northwest Biotherapeutics announced today that the Company will host a conference call and webcast  with CEO Linda Powers today, May…
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Northwest Biotherapeutics Releases Promising Early Results in DCVax Direct Phase 1 Trial (NWBO, $6.20, content of this note is not limited to subscribers)

Overview

Northwest Biotherapeutics told investors that it would discuss initial results of the phase 1/2 trial of DCVax-Direct in inoperable solid…
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Northwest Biotherapeutics: Update On DCVax-Direct Based on ASCO Abstract and Positive, Early Results for First Patient Reported On (NWBO, Buy, and $5.94)

Investment Conclusion

The ASCO abstract on DCVax-Direct was released last night. It contains only a description of the drug and the…
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ImmunoCellular Therapeutics: Comments on ASCO Abstract on ICT-107 (IMUC, Trading Buy, $1.20)

Investment Overview

The abstract on ICT-107 was released last night and is just a brief summary of the trial results as…
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Cytokinetics: There Yet May Be a Path Forward to Develop Tirasemtiv in ALS (CYTK, Buy, $4.49, Paid Subscribers)

Overview

Cytokinetics held a conference call on the results of the BENEFIT-ALS trial on the morning of April 30. The Company…
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Cytokinetics Announces that Tirasemtiv Phase 2b Trial in ALS Failed (CYTK, Buy, $5.01)

Cytokinetics announced that tirasemtiv failed to reach the primary endpoint in the phase 2b BENEFIT-ALS trial in ALS. The mean…
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ImmunoCellular Therapeutics Trading Opportunity (IMUC, Not rated, $1.19, Paid Subscribers)

ImmunoCellular Therapeutics just announced that an abstract describing the phase II trial of its dendritic cell-based cancer vaccine ICT-107 in…
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Thoughts on the Market Correction in Biotechnology Stocks

This Has Been a Tough Correction

The recent sharp market correction and rotation out of growth stocks like biotechnology and technology…
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Northwest Biotherapeutics: Just Announced Financing Signals High Expectations for Use of DCVax-L under German Hospital Exemption Program (NWBO, $6.75, Paid Subscribers)

Purpose of New Financing

Northwest Biotherapeutics just announced a financing in which a single institutional investor bought $15 million of stock…
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Cytokinetics: The Critical Phase 2b Results for Tirasemtiv Should be Released on April 29th (CYTK, $8.88, Buy, Paid Subscribers Only)

Phase 2b Data on Tirasemtiv will be Presented on April 29th

Cytokinetics has an extremely important binary event upcoming as the…
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Refuting Feuerstein’s Latest Negative Blog on Northwest Biotherapeutics (NWBO, Buy, $7.56)

Before I Get Into This Article, a Word to My Subscribers

I want to apologize to my subscribers for a software…
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Northwest Biotherapeutics (NWBO, Buy, $7.59) What the 2014 10-K Had to Say about the Approval of DCVax-L under the German Early Access Program

Purpose of This Blog

The approval of DCVax-L under the hospital exemption early access program was a stunning positive in my…
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My Investment Thinking on Biotechnology Stocks in the Aftermath of the Recent Correction

Introduction

The biotechnology stocks have gone through a correction over the last few days that has shaken investor confidence. Traders are…
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Some Thoughts on Short Selling of Biotechnology Stocks (Paid Subscribers)

I am a fundamentalist and am long term oriented. However, there is a darker side to the market that requires…
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Northwest Biotherapeutics (NWBO, Buy, $7.90): DCVax-L Is Approved in Germany under Hospital Exemption Early Access Program

Introduction

Please read this report very carefully. This is the first time that any systemic drug has been approved under the…
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Northwest Biotherapeutics (NWBO, $6.06, Buy): Comments on First Interim Look at DCVax-L Trial and Recent Weakness in the Stock

Reason for Stock Weakness

The stock of Northwest Biotherapeutics (NWBO) has been under pressure that appears largely to have been caused…
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Current Recommended Stocks and an Analysis of Past Recommendations, March 5, 2014)

Current Recommended Stocks

I only started offering research on my website on a subscription basis in early December, 2013 so that…
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SmithOnStocks Mailbox February 25, 2014

I have found that there are some very smart people out there who have interesting questions and perspectives concerning my…
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Cytokinetics: Institutional Investors Give BENEFIT-ALS Potential Results a Vote of Confidence (CYTK, $9.06)

Cytokinetics (CYTK) announced that it has completed an equity offering in which it issued 4.375 million shares at a price…
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Cadence: A Post Mortem on a Successful Investment and What to Do with the Proceeds (CADX, $14.00)

Mallinckrodt (MNK) announced that one of its subsidiaries will start a tender offer to acquire all of the outstanding shares…
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Cadence: Patent Settlement With Sandoz Increases Confidence That Ofirmev Will Have Exclusivity Through December 6, 2020 (CADX, $10.98)

On January 30, 2014, Cadence (CADX) announced that it had entered into a settlement agreement with Sandoz to resolve pending…
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SmithOnStocks Mailbox January 28, 2014

In my writing, I have found that there are some very smart people out there who have interesting questions and…
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Agenda for BIO CEO Conference

I will be attending the annual BIO CEO Conference in New York on February 10 and 11. I have included…
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Agenus: Key Opinion Leader Support Builds for Prophage (AGEN, $3.27)

Can Cancer Vaccines Work?

The issue of whether cancer vaccines are viable therapeutic candidates has been hotly debated by investors. A…
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Thoughts on the Price Surge of Cytokinetics (CYTK, $8.75)

Cytokinetics has been on a tear this year. Is started the year at $6.72 and closed yesterday (January 10) at…
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If You’re Going to San Francisco

This has always been one of my favorite songs and I love the lyrics.

If you're going to San Francisco
Be sure…
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A Trading Call on a Stock That I Like for the Long Term

I want to bring to the attention of paid subscribers to my website an idea that is essentially a trading…
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Adam Feuerstein’s Views on Northwest Biotherapeutics (NWBO, $3.37)

Adam Feuerstein has consistently disagreed with authors who believe that there is a sound basis for Northwest Biotherapeutics (NWBO) conducting…
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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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What SmithOnStocks Is All About

Welcome to SmithOnStocks

I want to welcome newsubscribers to my website. SmithOnStocks.com has been a process two years in the making…
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Discovery Laboratories: An Asymmetric Opportunity (DSCO, $2.07)

I have just published the first of a series of reports on Discovery Laboratories.
Instead of publishing an extensive report (which…
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Cadence: Best Case Outcome on Ofirmev Patent Litigation (CADX, $7.88)

Patent Litigation on Ofirmev
Cadence just received the best possible news on a trial judge’s decision on a patent challenge against…
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Antares Marketing Agreement on Otrexup with Leo is a Nice Positive (ATRS, $3.93)

Antares is preparing to launch Otrexup for rheumatoid arthritis in the US in late January of 2014 with its own…
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Discovery Laboratories: Removal of Financing Overhang Is a Catalyst for the Stock (DSCO, $2.17)

Investment Thesis
I believe that the recent stock offering by Discovery Laboratories (DSCO) removes the financing overhang that has been holding…
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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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Antares: Thoughts on the Upcoming Otrexup Launch (ATRS, $3.64)

Investment Thesis
Antares is preparing to launch Otrexup in January 2014; it is the first product it has ever introduced and…
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Cadence Pharmaceuticals: The Ofirmev Launch is a Spectacular Success, but Investors are Focused on Patent Litigation (CADX, $4.99)

Investment Thesis
By every measure, the launch of Ofirmev which began in January 2011, has been a spectacular success and continues…
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Celldex (CLDX, $23.06): Previewing the Imminent Data Release on Rindopepimut

Note: Comprehensive reports are now available to paid subscribers and can be found in the Reports section.

Investment Background and Thesis
This post is the…
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Cytokinetics: 2014 Will Bring Critical Data Readouts on Tirasemtiv and Omecamtiv Mecarbil (CYTK, $6.03)

Key Takeaways From 3Q, 2013 Conference Call
The BENEFIT-ALS trial of tirasemtiv has nearly completed enrollment and Cytokinetics (CYTK) believes that…
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Celldex: Why Investors Are So Excited About the Company (CLDX, Hold, $24.39)

This post is an excerpt from the report: Celldex: Pipeline Promise Has Been Embraced by Wall Street

Comprehensive reports are now available…
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pSivida: Thoughts on pSivida in the Aftermath of the Complete Response Letter on Iluvien (PSDV, $2.87)

Background on the Complete Response Letter
This note focuses on the implications of the complete response letter (CRL) received by Alimera…
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Cytokinetics: Previewing the Release of Data from the ATOMIC-AHF Trial of Omecamtiv Mecarbil (CYTK, $9.95)

Investment Overview

In my last note, I wrote that I thought the ATOMIC-AHF, phase IIb trial of the intravenous dosage form…
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Cadence: Comments on Patent Office Re-examination of Key Cadence Patent

Cadence (CADX) announced that the US patent office has issued an initial action on the re-examination of one of two…
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Cadence: Ofirmev Sales Are Extremely Strong; Ofirmev Patent Decision Could Come by Yearend (CADX, $6.80)

Investment Thesis
Cadence (CADX) reported another strong quarter for Ofirmev and in my mind the only question about the launch is…
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Trius: Will there be a Higher Bidder and what is the CVR Worth? (TSRX; $14.10)

What is the CVR Worth?
I wanted to address some additional points in regard to the proposed acquisition of Trius (TSRX)…
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InSite Vision: DOUBle Trial Results are Disappointing-What Comes Next? (INSV.OB, $0.33)

Summary and Investment Thesis
InSite Vision (INSV.OB) just reported that topline results for AzaSite Plus and DexaSite in the DOUBle trial…
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Cytokinetics: Another Positive Deal for Shareholders, This Time with Astellas (CYTK, $11.81)

Cytokinetics (CYTK) has completed its second meaningful deal in two weeks. Today they announced a deal with Astellas (ALPMY) and…
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Cytokinetics (CYTK, $1.40) Receives a Vote of Confidence from Amgen

Cytokinetics (CYTK) has announced an expansion of the partnering agreement with Amgen (AMGN) for omecamtiv mecarbil, the Company’s lead product…
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Northwest Biotherapeutics ($3.44): M.D. Anderson’s Lead Role in DCVax Direct Trial is Encouraging

Northwest Biotherapeutics (NWBO) announced today that the phase I/II trial of DCVax Direct has been initiated at M.D. Anderson Cancer…
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Thoughts on the Growing Crisis of Bacterial Resistance to Antibiotics

Investment Overview
We hear constantly from the media about problems with bacterial resistance to antibiotics. I think that this is an…
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SmithOnStocks Opines on Biotechnology Stocks, June 10, 2013

Introduction
This week’s edition of SmithOnStocks Opines includes brief comments on news concerning ImmunoCellular Therapeutics (IMUC) and Cadence (CADX), last week…
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SmithOnStocks Opines on Biotechnology Stocks, June 2, 2013

Overview of This Week's Report
This week I published a major report on Alimera Sciences and pSivida which led to my…
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SmithOnStocks Opines on Biotechnology Stocks, May 28, 2013

Introduction
I have started to write a newsletter on a weekly or bi-weekly basis to supplement my reports and blogs. In…
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Neuralstem: Update on Phase I Trial of Neural Stem Cells in ALS is Encouraging (CUR, $1.45)

Purpose of Report
An encouraging update on the phase I trial of Neuralstem's (CUR) neural stem cells in ALS was just…
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SmithOnStocks Opines on Stocks May 19, Edition

One Approach for Investing in Emerging Biotechnology Stocks
I write on biotechnology and pharmaceutical companies of all sizes, but I have…
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Antares: Reiteration of My Buy Recommendation (ATRS, $4.00)

Investment Thesis
It has been some time since I have written on Antares (ATRS); in fact my last note was in…
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Neuralstem: Update on ALS Trial Could be a Catalyst for the Stock (CUR, $1.30)

Key Investment Summary
The lead investigator will give an important update on the ALS phase I trial on Friday, May 17…
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Trius Therapeutics: Newly Allowed Patent Provides Important New Dimension to Investment Outlook (TSRX, $8.50)

Investment Thesis

Trius announced an important new development today that bolsters my investment case for Trius (TSRX) and I continue with…
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SmithOnStocks Opines on Recent Biotech Events

Introduction
I am beginning a new approach in my writing on biotechnology companies. As those who have followed my writing may…
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ImmunoCellular Therapeutics: Marching Toward Top Line Data for ICT-107 in 4Q, 2013 (IMUC, $2.42)

Introduction
This note is based on comments made by management during the ImmunoCellular Therapeutics (IMUC) conference call of May 9, 2013.
 
Data…
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InSite Vision: An Over-looked Company with Two Interesting Drug Candidates and a Big Upcoming Catalyst (INSV.OB, $0.31)

Results of the Important DOUBle Trial Are Imminent
During the May 8th quarterly conference call, management said that enrollment in the…
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Transcept: Throwing in the Towel on Intermezzo (TSPT, $3.59)

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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Cadence Pharmaceuticals: Ofirmev Launch is Strong; Resolution of Patent Issues Could Be Soon (CADX, $6.86)

Investment Thesis
On May 31, 2012, I wrote a blog on Cadence entitled " Ofirmev Launch…
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A.P. Pharma: Management Change is a Positive for the Stock (APPA.OB, $0.39)

Introduction
This report deals with the just announced management change at A.P. Pharma (APPA.OB) and the positive impact that I believe…
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Discovery Laboratories: Still Another Delay in the Surfaxin Launch (DSCO, $2.00)

Overview
Discovery Laboratories just announced still another delay in the launch of Surfaxin. The Company received five Complete Response letters dating…
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Cytokinetics: Key Issues for Beginning Phase III for Omecamtiv Mecarbil in Congestive Heart Failure (CYTK, $1.15)

Overview and Investment Importance
Those who read my initiation report on Cytokinetics (CYTK) understand that the importance of successfully conducting…
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Trius: Clinical Trials Show Important Differentiation of Tedizolid from Zyvox (TSRX, $6.48)

Investment Summary and Opinion
I attended Trius' (TSRX) CEO Jeff Stein's presentation at the BioCentury Conference in New York on April…
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Besivance Royalty Deal Extends InSite’s Cash Runway (INSV.OB, $0.31)

InSite Vision(INSV.OB) announced that it agreed to sell its royalty stream on future sales of Besivance, a product that is…
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A.P. Pharma Receives Complete Response Letter on APF530 (APPA.OB, $0.34)

Overview
A.P. Pharma has just released the disappointing news that it has received a Complete Response Letter for APF530. The press…
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Investment Implications of the Acquisition of MAP Pharmaceuticals by Allergan

Allergan to Acquire MAP Pharmaceuticals
Allergan (AGN) has announced that it will acquire MAP Pharmaceuticals (MAPP) at a price of $25…
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Cadence: Management Guides to a Near Doubling of Ofirmev Sales in 2013 (CADX, $5.23)

My confidence in my long standing Buy recommendation on Cadence (CADX) has been strengthened by its pre-announcement that 4Q, 2012…
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InSite Vision: Upcoming Results on the DOUBle Trial May Not Be as Binary as I Have Been Thinking

I met with the CEO, Tim Ruane, and CFO, Lou Drapeau, of InSite Vision (INSV.OB) in early January during my…
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Discovery Laboratories Announces Changing of the Guard (DSCO, $2.21)

New Board and New CEO
There has been a significant leadership change at Discovery Laboratories (DSCO) which has appointed a new…
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Transcept: Direct to Consumer Advertising Campaign Could be the Tipping Point for Intermezzo

Investment Overview

The launch of Intermezzo began on April 4, 2012 and so far, it has been disappointing for investors. Purdue…
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My Buy Rating on Cadence Pharmaceticals is Bolstered by Ofirmev Patent Settlement with Perrigo

Investment Conclusion
Today’s announcement that Cadence (CADX) has entered into a settlement with Perrigo (PRGO) on patent litigation regarding Ofirmev is…
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Initiation of Coverage on NovaBay with a Buy

Introduction

I have just written a new report on NovaBay (NBY) called NovaBay’s Robust Clinical Pipeline Approaches Critical Clinical Trial Results…
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Northwest Biotherapeutics Stock Surges 94% on Perfect Storm Created by Short Squeeze and New Buying Interest (NWBOD, $10.75)

Investment Summary
Northwest Biotherapeutics’ (NWBOD) stock price increased 94% on Friday, September 28 to $10.95 per share and investors are asking…
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Thoughts on Northwest Biotherapeutics’ Reverse Stock Split

Northwest Biotherapeutics (NWBO.OB) announced a 1 for 16 reverse stock split. This is a first step in a planned public…
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Discovery Laboratories: The Street Is Getting on Board With Me

My Recent History on Discovery Laboratories

On February 22, 2012, I initiated coverage of Discover Laboratories with a Buy and at…
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Manish Singh Resigns as CEO of ImmunoCellular Therapeutics: Implications for Northwest Biotherapeutics and ImmunoCellular

ImmunoCellular (IMUC.OB) has issued a press release stating that Manish Singh has resigned as CEO. He will be succeeded in…
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Johnson & Johnson: A Core Holding for the Long Haul

 

I have just written a report on JNJ in which I reiterated my Buy recommendation. I don’t see a vibrant…
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Cadence Pharmaceuticals Ofirmev Has Gained Traction Producing Upside Surprise in 2Q, 2012

I reiterate my Buy recommendation on Cadence. The Ofirmev launch has now gained traction as just reported 2Q, 2012 revenues…
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Spectrum Pharmaceuticals: Fusilev Has Explosive Month in June

In my recent article Spectrum Pharmaceuticals: The Bull and the Bear Case, I wrote about the tug of war between…
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Northwest Biotherapeutics' DC Vax Cancer Vaccine May Be a Game Changer In Cancer

 

I am starting my coverage of Northwest Biotherapeutics (NWBO.OB) with a Buy. I became interested in this small bulletin board…
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Spectrum Pharmaceuticals: The Bear and Bull Case

At the request of some subscribers to my website, I have been asked to take a look at the bull…
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Issuance of Complete Response Letter for Eliquis Doesn’t Alter My Buy on Bristol-Myers Squibb

Investment Opinion

I believe that the issuance of a Complete Response Letter to Bristol-Myers Squibb (BMY) and Pfizer (PFE) for the…
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InSite Vision: Initiating Coverage on a Promising Company with a Robust Late Stage Product Portfolio

I have just published a new report and initiated coverage of InSite Vision (INSV, $0.30) with a Buy. The core…
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Initiating Coverage of A.P. Pharma with a Buy (APPA, $0.42)

I have just published a report initiating coverage on A.P. Pharma (APPA, $0.42) in which I recommend purchase; my 2015…
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Dendreon Turns Reins Over to New CEO

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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New Scientific Abstact Suggests That Median Overall Survival for Provenge is 7.8 Months, Not 4.1 (DNDN, $14.09)

Conclusions
I think that most physicians and investors were aware that the analysis of Dendreon's (DNDN) Provenge in the Phase III IMPACT…
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Johnson & Johnson's Turnaround Led by New Drug Products is Underway (JNJ, $65.15)

Investment Conclusion
JNJ has gone through three very difficult years as EPS increased only slightly from $4.63 in 2009 to $5.00…
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Investors' Concerns About the Intermezzo Launch Weighs on the Stock and Creates a Buying Opportunity

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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Cubist Makes Attractive Bid for Adolor

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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Contrave Is Given New Life as FDA Reverses its Position on Design of Cardiovacular Outcomes Trial (OREX, $2.45)

Investment Opinion
Orexigen’s (OREX) anti-obesity drug Contrave has been given new life as the FDA reversed a previous position that would…
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Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review

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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FDA Cardiovascular and Renal Advisory Committee Goes Against FDA View 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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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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Dapagliflozin is Voted Down 6 to 9 by Advisory Committee: What's Next (BMY, $28.77)

Overview of Advisory Committee Meeting
 
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 6-9 against approval of dapagliflozin for the…
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Santarus 2009 Analyst Day Highlights (SNTS, $1.98)

Management was quite optimistic about prospects for 2009 as both Zegerid and Glumetza are doing well. The company is looking…
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