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Vivus Inc. (VVUS) FDA Approval 2012 - Qnexa®
Vivus Inc. (VVUS) stock has been steadily rising as we head into 2012 due to the fact that the company will be seeking FDA Approval for Qnexa. Vivus Inc. (VVUS) recently put out their SEQUEL trial results which were ok but the big FDA Approval decision is due to come out on or before April 17, 2012. This date will be key and one you will want to write down on your Calendar.
Update - Qnexa FDA Advisory Committee vote expected on 2/22/12 February 22, 2011
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28 , 2010. We resubmitted the Qnexa NDA in October 2011 , with an FDA action date of April 17 , 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29 , 2012. For more information about the company, please visit www.vivus.com
VIVUS, Inc. (NASDAQ:VVUS) today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership. The SEQUEL study evaluated the long-term efficacy and safety of Qnexa in 676 overweight and obese subjects with cardiometabolic disease. In addition to 10% sustained weight loss, the study also found that significantly more placebo patients became diabetic over the two years as compared to patients treated with Qnexa. The data suggest that Qnexa, in conjunction with lifestyle modification, may provide a well-tolerated and effective option for the sustained treatment of obesity and the potential to prevent many in this population from progressing to type 2 diabetes.
"Recent data show that diabetes, like obesity, has become a rapidly growing epidemic, with nearly 1 in 10 adults potentially affected by the disease," said lead investigator W. Timothy Garvey M.D ., director of the Nutrition Obesity Research Center, University of Alabama at Birmingham . "Results from the SEQUEL study underscore Qnexa's potential as a non-surgical option for sustained weight loss and improvements in comorbidities in overweight and obese patients."
Tags: 2012, Vivus, approval, date, decision, diet, fda, pill, qnexa, stock, More…
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Replies to This Discussion
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Permalink Reply by Stocks To Buy on -
VIVUS Inc. (VVUS) released news last night which analysts say isn't doesn't favor the company for FDA Approval in 2012 - VIVUS Reports Topline Findings From FORTRESS
http://finance.yahoo.com/news/VIVUS-Reports-Topline-prnews-19906039...
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Permalink Reply by Stocks To Buy on
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Qnexa FDA Advisory Committee vote expected on 2/22/12 February 22, 2011
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Permalink Reply by Stocks To Buy on
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Looks like the FDA Advisory panel likes the drug data and voted 20-2 yes for approval. The FDA will now vote in a few months. ARNA is up on this news while VVUS remains halted.
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Permalink Reply by Stocks To Buy on
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OREX and ARNA are both higher
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Permalink Reply by Greg Gross on -
Is VVUS really halted? It looks like it's up 95% in after market to over $20! :-O
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Permalink Reply by Stocks To Buy on
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VVUS opens above $20
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Permalink Reply by Stocks To Buy on
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FDA Advisory Committee Recommends Approval of Qnexa®
VIVUS, Inc. (NASDAQ:VVUS) today 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. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, President of VIVUS. "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."
The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the review of the New Drug Application (NDA) that was submitted for Qnexa in October 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for Qnexa is April 17, 2012.
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Top MemberPermalink Reply by Josh Odin on -
Arna is a good buy maybe...
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Permalink Reply by Izzy S on
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How much more do you see OREX, ARNA, and VVUS going (short term & long term) and do you recommend one over the other? Thanks
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Permalink Reply by Stocks To Buy on
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Qnexa is really moving VVUS stock, and Qnexa is the top trending search on google right now....people are very interested and will be trying to buy it. This could pave the way for both ARNA and OREX to have their drugs approved. VVUS is higher by 110% to $22 this morning
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Permalink Reply by Stocks To Buy on
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Vivus (VVUS) receives $36 price target from Credit Suisse this morning, however, Jefferies is still cautious about FDA Approval April 17, 2012
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Permalink Reply by Stocks To Buy on
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VVUS starting to break down now - below $20, low of the day
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