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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
05/02/201616:05:00Arena Pharmaceuticals to Host First Quarter 2016 Financial Results...
04/28/201616:40:13Additional Proxy Soliciting Materials (definitive) (defa14a)
04/28/201616:22:41Proxy Statement (definitive) (def 14a)
04/12/201613:33:22Current Report Filing (8-k)
04/12/201608:00:00Arena Pharmaceuticals Reports Favorable Results from Phase 1b...
03/21/201606:07:19Current Report Filing (8-k)
03/04/201618:21:25Statement of Changes in Beneficial Ownership (4)
03/04/201618:19:54Statement of Changes in Beneficial Ownership (4)
03/04/201618:19:23Statement of Changes in Beneficial Ownership (4)
03/04/201618:17:39Statement of Changes in Beneficial Ownership (4)
03/04/201618:15:47Statement of Changes in Beneficial Ownership (4)
03/04/201618:14:18Statement of Changes in Beneficial Ownership (4)
02/29/201617:21:52Current Report Filing (8-k)
02/29/201616:00:00Arena Pharmaceuticals Reports Fourth Quarter and Full Year 2015...
02/23/201608:00:00Arena Pharmaceuticals to Host Fourth Quarter and Full Year 2015...
02/11/201611:00:58Schedule 13g<br /> (sc 13g/a)
02/10/201614:46:54Amended Statement of Ownership (sc 13g/a)
01/25/201613:50:21Amended Statement of Ownership (sc 13g/a)
01/13/201609:41:00U.S. Hot Stocks: Hot Stocks to Watch
01/12/201616:55:03Current Report Filing (8-k)

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