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Smith on Stocks Blog

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

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

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

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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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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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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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 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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