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Expert Financial Analysis and Reporting

Post archive for ‘LinkedIn’

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 3 ACT IV study of Rintega (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma. The analysis concluded that the trial will not achieve statistical significance for its primary endpoint of overall survival. Celldex received […]

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 to its epinephrine ANDA in which the FDA identified certain major deficiencies. Teva is evaluating the CRL and intends to submit a response. Due to the major nature of the CRL, Teva expects that […]

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 ago) when a new product launch coincided with excellent stock performance as one might expect. Paradoxically, now launches more often than not lead to disappointing stock performance. The most important reason for this in […]

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 is facing two major uncertainties. The launch of its first drug Veltassa (patiromer) began in December, 2015 so that the Company is fighting through all types of reimbursement and formulary access hurdles with managed […]

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 in the back of the eye. Eye drops cannot deliver drugs effectively to the retina and systemic therapy requires large doses of drug to be delivered in order to allow some small part of […]

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 of blogs that give highlights and impressions from company presentations that I attended. These range from companies that I am deeply involved in to companies that I have seen for the first time. This […]

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 phase 2a trial of Aerosurf in younger babies of 26 to 28 weeks gestational age (GA). The key objective is to show safety. Encouraging results from this trial have already been reported for older […]

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 five member Board of Directors with the appointment of Ms. Susan Bayh and Mr. Cofer Black as independent Directors.  Neither Ms. Bayh nor Mr. Black has had dealings with or worked with the Company previously. […]

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 drop in the stock market indices has set off a much steeper plunge in the stock prices of emerging biotechnology companies which are the focus of SmithOnStocks. In this volatile and depressing environment, there […]

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 NSI-566 neural stem cells in ALS might begin and on providing details of the trial design. This silence may about to be broken as the Company has just announced that it will be presenting […]