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Vivus Submits Qnexa Response To FDA; Meeting Set For January

DOW JONES NEWSWIRES Vivus Inc. (VVUS) said it has responded to the U.S. Food and Drug Administration's concerns about obesity drug Qnexa and has set a meeting for late January to discuss the company's latest effort to win its approval. The disclosure follows an FDA panel's positive recommendation last week of Orexigen Therapeutics Inc.'s (OREX) weight-loss drug Contrave. The FDA doesn't have to follow the panel's recommendation, but the positive vote puts Orexigen ahead of Vivus and Arena Pharmaceuticals Inc. (ARNA)--which received negative recommendations from similar panels earlier this year--by easing investor concerns that major clinical studies would be needed before approval. The FDA in October issued a "complete response letter" for Qnexa saying it couldn't approve the drug application in its current form. The agency asked the company for a comprehensive assessment of Qnexa's potential to cause birth defects and for Vivus to provide evidence that the product doesn't increase the risk for major adverse cardiovascular events. The company said the FDA didn't request a new clinical trial, but asked for two-year study results involving Qnexa to be submitted. "Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress Vivus is making in seeking U.S. approval of Qnexa for the treatment of obesity," Chief Executive Leland Wilson said Tuesday. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA." Vivus shares closed Monday at $9.42 and were inactive premarket. The stock is up 45% this month amid the positive news on Orexigen's Contrave. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com

Stock News for Arena (ARNA)
DateTimeHeadline
04/24/201508:10:02Arena Pharmaceuticals Inc.'s Plan to Win the Obesity Drug War
04/21/201509:06:023 Promising Small-Caps Under $10 You Can Buy Right Now
04/15/201508:02:023 Promising Healthcare Stocks Under $10
04/13/201511:00:47Arena's 15,000 Scripts Set Pace Vs. Competitors
04/13/201510:23:41Orexigen: Contrave Scripts Dip - Were My Concerns About Advertising...
04/13/201507:59:01Arena Gets Closer On Extended Release Formulation Of Belviq
04/12/201514:03:03The Best Stock to Invest in Obesity Drugs
04/10/201510:27:12Arena's Partner Eisai Is Slashing Jobs - What Investors Need...
04/10/201509:29:04Arena secures new Belviq patent; Eisai cuts sales force
04/10/201508:48:57Arena completes two Phase 1 trials for once-daily formulation...
04/10/201508:31:53Current Report Filing (8-k)
04/10/201508:00:00Eisai and Arena Pharmaceuticals Complete Registrational Trials...
04/09/201511:45:18Novo Nordisk Quietly Becoming Big Player In Obesity Space
04/09/201508:00:00Arena Pharmaceuticals to Present at the Annual Needham Healthcare...
04/07/201508:00:00Arena Pharmaceuticals Receives Additional Patent for BELVIQ®...
04/04/201513:30:31NASH Series: Novo Nordisk And Cadila Healthcare
04/02/201521:20:16Novo Nordisk Entry Is Bullish For The Anti-Obesity Space
04/01/201518:59:27Statement of Changes in Beneficial Ownership (4)
03/30/201519:57:55Arena - Assessing Belviq In South Korea
03/28/201505:21:38Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely

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