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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
09/01/201617:00:17Current Report Filing (8-k)
09/01/201616:30:00Arena Pharmaceutics Announces Formation of Beacon Discovery
08/25/201606:04:31Current Report Filing (8-k)
08/15/201616:37:44Statement of Changes in Beneficial Ownership (4)
08/15/201616:35:58Initial Statement of Beneficial Ownership (3)
08/15/201616:03:47Current Report Filing (8-k)
08/15/201607:00:00Arena Pharmaceuticals Announces Appointment of Vincent Aurentz...
08/09/201606:10:17Quarterly Report (10-q)
08/08/201616:12:58Current Report Filing (8-k)
08/08/201616:01:00Arena Pharmaceuticals Reports Second Quarter 2016 Financial Results...
08/01/201616:01:00Arena Pharmaceuticals to Release Second Quarter 2016 Financial...
07/19/201609:02:07Current Report Filing (8-k)
07/19/201608:26:00Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of...
07/14/201608:05:00Eisai and Arena Pharmaceuticals Announce Regulatory Approval...
07/06/201606:02:10Notice of Effectiveness (effect)
07/01/201609:45:00U.S. Hot Stocks: Hot Stocks to Watch
06/30/201616:17:13Current Report Filing (8-k)
06/30/201616:05:00Arena Pharmaceuticals Announces Shift to Focus on Proprietary...
06/23/201607:30:00How These Biotech's Stocks are Performing? - Intrexon, Vertex...
06/16/201606:07:05Current Report Filing (8-k)

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