09:43 ET VVUS
Vivus: Color on today's Qnexa decision -- ARNA likely to be a big mover as well (25.80 -2.82) -Update
The FDA will make a decision on VVUS's Qnexa weight-loss drug today, which will be a major volatility event for VVUS and its weight-loss drug peers ARNA and OREX. VVUS just saw a sharp downward move on heavy volume, but the news doesn't appear to be out yet. VVUS will likely be halted ahead of the decision news.
For some background, VVUS submitted an NDA for its weight loss drug Qnexa on October 17, 2011. In late February, 2012 an FDA Advisory Committee voted 20-2 in favor of recommending Qnexa for approval. On April 9, 2012 the FDA announced an extension of the PDUFA date to July 17, 2012 to provide more time to review the submission. Additionally, the Committee for Medicinal Products for Human Use has rescheduled the decision process on the Marketing Authorization Application for Qnexa to September, 2012... VVUS is +200% on the year ahead of today's FDA decision.
Today's decision on VVUS follows the June 27 approval of ARNA's weight loss drug lorcaserin (trade name Belviq). Lorcaserin is currently under review with the European Medicines Agency (EMA)... ARNA would benefit from a VVUS delay or decision not to approve at this time, but may see a negative response to a VVUS approval due to competitive concerns.
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