VIVUS (VVUS) Volatility Lower into PDUFA for Qnexa
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VIVUS (Nasdaq: VVUS) shares are slightly higher early Thursday as the pharma nears its PDUFA date with the FDA for its proposed weight-loss drug Qnexa.
Shares have been ramping higher since peer Arena Pharma (Nasdaq: ARNA) got a positive outcome from the FDA for its lorcaserin drug in May and also two weeks ago. Investors have been banking on a similar outcome for Qnexa.
On Feb 22nd, VIVUS announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.
On April 9th, VIVUS reported extension of its PDUFA date until July 17th due to submission of the Qnexa Risk Evaluation and Mitigation Strategy (REMS), considered a "major amendment to the NDA."
Volatility on the stock has been trending lower, but is still well above the trailing annual daily average.
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Shares have been ramping higher since peer Arena Pharma (Nasdaq: ARNA) got a positive outcome from the FDA for its lorcaserin drug in May and also two weeks ago. Investors have been banking on a similar outcome for Qnexa.
On Feb 22nd, VIVUS announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.
On April 9th, VIVUS reported extension of its PDUFA date until July 17th due to submission of the Qnexa Risk Evaluation and Mitigation Strategy (REMS), considered a "major amendment to the NDA."
Volatility on the stock has been trending lower, but is still well above the trailing annual daily average.
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