Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 3000%, and 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these[More...]

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA (...)[More...]

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars. 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision (...)[More...]

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved). The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking[More...]

The accompanying table (click to enlarge) includes an updated calendar of 78 expected FDA new product decisions with more detailed comments for each entry. Click here for a link to my previous FDA calendars and the list below highlights companies with pending decisions + market caps below $100M, making them ideal candidates for extreme trading opportunities. <a[More...]