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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
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05/14/201508:00:00Eisai and Arena Pharmaceuticals Announce Presentation of Lorcaserin...
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05/12/201517:05:54Orexigen Terminates Required Study for Diet Drug Contrave
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05/11/201517:44:00Quarterly Report (10-q)
05/11/201516:22:25Current Report Filing (8-k)
05/11/201516:07:00Arena Pharmaceuticals Provides Corporate Update and Reports First...
05/11/201516:01:00Arena Pharmaceuticals and Roivant Sciences Enter into Collaboration...
05/08/201508:00:00Arena Pharmaceuticals to Present at the Bank of America Merrill...
05/07/201508:00:00Arena Pharmaceuticals to Host First Quarter 2015 Financial Results...
04/30/201513:11:57Current Report Filing (8-k)
04/29/201516:26:56Additional Proxy Soliciting Materials (definitive) (defa14a)
04/29/201516:24:19Proxy Statement (definitive) (def 14a)
04/29/201508:00:00Arena Pharmaceuticals Reports Favorable Results from Phase 1...
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
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