VIVUS, Inc. (NASDAQ: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted in favour by 20 to 2. The PDUFA date for Qnexa is April 17, 2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) provided a pipeline update noting that it expects to complete enrolment in the Phase 2b portion of its Phase 2b/3 trial of ganetespib in combination with docetaxel vs. docetaxel alone in patients with advanced NSCLC, in 2Q 2012 (GALAXY trial), with interim Phase 2b results also in 2Q. Final PFS data and preliminary OS data from the Phase 2b portion are expected in 2H 2012 and initiation of the Phase 3 portion expected during 2H 2012.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) said in its annual report that it intends to submit the chemistry, manufacturing and controls section of the metreleptin BLA to treat diabetes and/or hypertriglyceridemia in pediatric and adult patients with inherited or acquired lipodystrophy, during 1H 2012. It intends to apply for fast-track and priority-review designation, which, if granted, could translate to a PDUFA action date by the end of 2012.
Horizon Pharma, Inc. (NASDAQ: HZNP) announced today that it has entered into a loan agreement with a group of lenders to provide $60 million in capital.
AVI BioPharma, Inc. (NASDAQ: AVII) announced it regained compliance with NASDAQ’s minimum $1.00 per share bid price requirement.
Dyax Corp. (NASDAQ: DYAX) gave a pipeline update today noting that data from its Phase 2 trial of ecallantide in angiotensin converting enzyme (ACE) inhibitor-induced angioedema, are due during 2H 2012.