Expert Financial Analysis and Reporting

Investment Thesis Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed glioblastoma has any implications for success or failure of DCVax-L in its phase 3 trial in newly diagnosed glioblastoma. This note explains why I believe there are no negative or positive implications. Subscribers have […]

Introduction If you read my note of yesterday, there can be no question that Amgen views omecamtiv mecarbil as a major breakthrough for the treatment of congestive heart failure if phase 2 data can be replicated in phase 3 trials. That note was based on a presentation by Cytokinetics at the Cowen conference on Monday […]

Introduction The Cowen conference in Boston is going on this week. I consider Cowen to have the best and broadest coverage of biotechnology on Wall Street. I am listening to webcasts from numerous companies this week at their annual healthcare conference. Cytokinetics presented on Monday March 8 and then Amgen held a dinner for investors […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]