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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
09/11/201408:50:11FDA Approves Orexigen's Diet Drug Contrave
11/15/201309:18:03OZ Management LP 3Q 13F: Largest Purchases -2-
11/15/201309:18:02OZ Management LP 3Q 13F: Largest Purchases
11/15/201308:27:55S.A.C. Capital Advisors LP 3Q 13F: Largest Eliminations
11/15/201308:27:52S.A.C. Capital Advisors LP 3Q 13F: Largest Purchases
11/15/201308:27:52S.A.C. Capital Advisors LP 3Q 13F: Largest Sales
11/15/201308:27:52S.A.C. Capital Advisors LP 3Q 13F: Largest -2-
01/17/201309:20:44U.S. HOT STOCK FUTURES: HOT STOCKS TO WATCH
01/07/201311:14:02Vivus's Free Promotion Lifts Prescriptions for Diet Drug
12/05/201215:02:25FDA Approves Highest Number of New Drugs Since 2004
07/19/201217:15:53Vivus Shares Drop Amid Report Questioning Diet Drug's Prospects
05/11/201217:25:10Dow Drops After JP Morgan Trading Loss; Consumer Sentiment Rises
03/26/201217:00:06US Stocks Erase Last Week's Losses; S&P Ends With Nearly Four-Year...
03/26/201209:12:54US STOCK FUTURES: HOT STOCKS TO WATCH
01/11/201209:09:45US Stock Futures: HOT STOCKS TO WATCH
01/10/201209:03:04Arena: FDA Accepts Resubmitted Application For Weight-Loss Drug...
11/22/201111:14:30Registration Effectiveness Orders Issued By The SEC
08/02/201107:29:39Arena, Eisai Diet Drug Less Concentrated In Human Brain Than...
02/17/201109:07:03Orexigen Financial Chief Cooper Resigns
02/10/201117:54:48Arena Pharma Finance Chief Hoffman To Leave Company

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