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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
07/30/201508:00:00Arena Pharmaceuticals to Host Second Quarter 2015 Financial Results...
07/29/201516:39:28Current Report Filing (8-k)
07/29/201508:00:00Arena Pharmaceuticals Initiates a Phase 2 Clinical Trial of APD334...
07/24/201509:25:00Biotechnology Stocks in Motion -- PDL BioPharma, Arena Pharma...
07/13/201518:38:41Initial Statement of Beneficial Ownership (3)
07/09/201517:22:52Current Report Filing (8-k)
07/05/201514:18:03Obesity Statistics Take a Wrong Turn in This Latest Study
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...

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