HGSI PDUFA date set. NVS AdCom September. OGXI to initiate Phase 3 NSCLC later this year + NKTR GEVA OSUR offering details

Jul 11, 2012 No Comments by

Human Genome Sciences, Inc. (Nasdaq: HGSI) announced the FDA has assigned a PDUFA date of December 15, 2012 for the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax. The resubmission follows a complete response letter, which was received on November 14, 2009.

The Anti-Infective Drugs Advisory Committee will meet on September 5, 2012, to discuss the new drug application of tobramycin inhalation powder, submitted by Novartis Pharmaceuticals Corporation (NYSE: NVS), for the management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced that it intends to initiate a Phase 3 clinical trial later this year of custirsen with docetaxel in patients with advanced or metastatic NSCLC who have been previously treated with a first-line platinum-based chemotherapy.

Nektar Therapeutics (Nasdaq: NKTR) announced the private placement of $125 million of 12.0% Senior Secured Notes Due in 2017. It intends to use the net proceeds from the offering of the Senior Secured Notes towards the repayment of its Convertible Subordinated Notes due September 28, 2012.

Synageva BioPharma Corp. (NASDAQ:GEVA) priced its underwritten public offering of common stock of 2,428,000 shares at $41.20 per share.

OraSure Technologies, Inc. (NASDAQ: OSUR) announced the pricing of an underwritten offering of 6,100,000 shares of its common stock at a price of $12.30 per share.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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