Seattle Genetics (SGEN) Seattle Genetics is on the verge of success with its program in Adcetris (brentuximab vedotin) for refractory or relapsed Hodgkin’s lymphoma (HL) and anaplastic large cell lymphoma (ALCL), having received unanimous Oncology Drug Advisory Committee (ODAC) recommendations for accelerated approval of the drug in both indications on July 14th. During the ODAC [...]
With companies reporting quarterly results, I decided to try something new here at BIP. Some companies that I am particularly excited about or feel have broad enough programs that they require more detail I will write full updates on as they report results, like my recent posts on Sangamo and Vertex. Others, like those below, [...]
Upcoming Catalysts: FDA Advisory Panel meeting for Fidaxomicin (clostridium difficile infection) - April 5, 2011 PDUFA date for FDA decision on Fidaxomicin NDA (clostridium difficile infection) - May 30, 2011 NDA submission of Pruvel (infectious diarrhea) – Q1 2011 Implied volatility of near-the-money puts and calls in the June expiration series fall around 100. These catalysts, collectively, are [...]
Upcoming Catalyst: FDA announcement whether or not to file Delcath’s 505b2 NDA for the melphalan chemosaturation delivery system for metastatic liver cancer. In addition, Delcath has requested a priority review. The decision is usually communicated within 60 days of the company’s NDA submission, which occurred on December 22, 2010, but can take as long as [...]