Expert Financial Analysis and Reporting

Purpose of This Report I have written frequently about omecamtiv mecarbil, Cytokinetics’ extremely promising new drug for congestive heart failure (CHF). I believe that it has the potential to be a therapeutic breakthrough for CHF which can significantly reduce mortality and morbidity. I see it as an add-on therapy to current standard of care drugs […]

Perspective and Overview on this Report The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L in newly diagnosed glioblastoma multiforme has been a nightmare for the Company and its investors. It seems that almost everything has ground to a halt in the last six months as Northwest awaits guidance […]

Investment Perspective Investors are closely watching the launch progress of Veltassa follwoing its December 2015 introduction. Medicare and managed care have set up barriers to prescribing that makes getting a prescription filled for a new drug laborious and time consuming and sometimes futile. With very few exceptions, most new product launches have disappointed investors to […]

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 […]