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Arena: FDA Accepts Resubmitted Application For Weight-Loss Drug Lorcaserin

DOW JONES NEWSWIRES Arena Pharmaceuticals Inc. (ARNA) and its partner, Eisai Co.'s (ESALY, 4523.TO) U.S. unit, said the U.S. Food and Drug Administration accepted their resubmitted new drug application for antiobesity drug lorcaserin. Shares of Arena jumped 11% premarket to $1.78 as the biotechnology company said the FDA assigned a new Prescription Drug User Fee Act target date of June 27. The stock has gained 15% over the past three months through Monday's close. The FDA requested in 2010 multiple sets of new data from Arena about lorcaserin, and the company said last week it submitted a response to the agency's two remaining concerns: the link between mammary tumors and a particular hormone in rats and deeper understanding about the drug's activity at three serotonin receptor subtypes. Arena is one of three small drug developers that had its respective weight-loss pill candidates rejected by the FDA recently. Vivus Inc. (VVUS) and Orexigen Therapuetics Inc. (OREX) were also turned down by the agency, which raised major safety concerns about all three treatments. Vivus resubmitted its application in October, while Orexigen suspended development of its weight-loss drug Contrave. Eisai's American depositary shares closed Monday at $40.76 and were inactive premarket. -By Melodie Warner, Dow Jones Newswires; 212-416-2283; melodie.warner@dowjones.com

Stock News for Arena (ARNA)
DateTimeHeadline
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
03/27/201507:59:45Arena Investors Need To Pay Attention To Competition
03/23/201508:49:56Arena Pharmaceuticals Could Have Better Luck In Quarter 2

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