VIVUS, Inc. (NASDAQ: VVUS) is going to likely have a huge day on Thursday. The FDA panel reviewing its Qnexa drug to treat obesity has voted overwhelmingly to offer FDA panel backing in favor of recommending an FDA approval. The vote per wire and online sources was much wider than expected with a 20 YES and 2 NO vote count.
A win for one obesity drug is actually considered a win for all potential obesity drugs because the FDA has been so reluctant to approve or allow obesity treatments compared to the past.
Orexigen Therapeutics, Inc. (NASDAQ: OREX) was up over 5% today at $3.21, but shares in the after-hours session are trading up a sharp 18% at $3.70.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) is often considered the #3 player of the group and its shares closed up 0.5% at $1.81 and is up another 2.2% at $1.89 in the after-hours trading session.
VIVUS was halted today so we will have to wait for the early pre-market trading indications early Thursday morning. After a $10.55 close yesterday, the 52-week trading range for the stock is $6.00 to $13.18.
While the short interest has actually been slightly down, there are still some 15.6 million shares as of the last NASDAQ short interest report and the average daily volume on non-news days is not even 3 million shares.
As a reminder, the FDA is not required to follow the panel recommendation (even if it usually does) for a formal marketing approval.
The FDA LIVE page called today…. The committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.
JON C. OGG