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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
06/16/201519:56:18Statement of Changes in Beneficial Ownership (4)
06/16/201519:54:53Statement of Changes in Beneficial Ownership (4)
06/16/201519:53:54Statement of Changes in Beneficial Ownership (4)
06/16/201519:52:47Statement of Changes in Beneficial Ownership (4)
06/16/201519:51:27Statement of Changes in Beneficial Ownership (4)
06/16/201517:00:28Securities Registration: Employee Benefit Plan (s-8)
06/16/201516:57:29Current Report Filing (8-k)
06/16/201516:30:00Arena Pharmaceuticals Announces the Departure of Chief Financial...
06/13/201508:04:033 Biotech Stocks That I Won't Buy
06/09/201511:06:03Obesity Drugs: Stocks to Watch
06/04/201513:30:00Lorcaserin HCl Data to be Presented at American Diabetes Association's...
05/26/201508:00:00Arena Pharmaceuticals to Present at the Jefferies 2015 Global...
05/16/201511:04:02Orexigen Therapeutics, Inc. Goes From Biotech Beauty to Dreadful...
05/16/201510:02:02Which of These Growth Stocks Is Most Worthy of Your Money?
05/14/201508:00:00Eisai and Arena Pharmaceuticals Announce Presentation of Lorcaserin...
05/13/201511:48:02Why Shares of Orexigen Therapeutics, Inc. Cratered Today
05/12/201517:05:54Orexigen Terminates Required Study for Diet Drug Contrave
05/12/201515:24:10Why It's Lights Out for Orexigen Therapeutics, Inc.
05/11/201517:44:00Quarterly Report (10-q)
05/11/201516:22:25Current Report Filing (8-k)

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