Vivus Shares Soar; FDA Panel Recommends Qnexa Approval

NEW YORK (TheStreet) -- Shares of VIVUS (VVUS) soared late Wednesday after the company confirmed a Food and Drug Administration advisory committee has recommended Qnexa, its proposed treatment for obesity in adults, receive marketing approval.

The stock was last quoted at $21.02, up 99.2%, on volume of 1.9 million, according to Nasdaq.com.

"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, the company's president, in a statement. "We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."

VIVUS said the committee voted 20-to-2 in favor of making the recommendation for approval based on a "favorable benefit-risk profile."

The company noted that the recommendation doesn't guarantee the drug will receive approval from the FDA. Rather the guidance will be considered when the FDA reviews the company's new drug application for Qnexa, which was submitted in October 2011. A previous bid for approval of Qnexa failed because of health safety concerns.

VIVUS added that the scheduled Prescription Drug User Fee Act date for an FDA decision on Qnexa is April 17.

The news sent shares of both Orexigen Therapeutics (OREX) and Arena Pharmaceuticals (ARNA) higher in the extended session as well.

Orexigen's stock jumped nearly 18% to $3.78 on volume of more than 700,000, while shares of Arena Pharmaceuticals rose 17% to $2.12 on volume of more than 4 million, according to Nasdaq.com.

Orexigen and Arena both have anti-obesity drugs in development, so the favorable news of Qnexa is being seen as a positive indicator for their efforts.

Check out TheStreet's quote page for VIVUS for year-to-date share performance, analyst ratings, earnings estimates and much more.

--Written by Michael Baron in New York.



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