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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
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
03/23/201506:51:27Vivus: Qsymia Sales Slip, Company Needs To Shift Into Gear
03/22/201512:56:03Biotech Stocks: 2 to Avoid, 1 to Buy
03/21/201505:11:59Orexigen - Contrave Scripts Up, Equity Down, Approval In Europe...
03/18/201517:46:50Statement of Changes in Beneficial Ownership (4)
03/16/201509:51:47Vivus' Qsymia Breaks 3-Week Stagnancy, Could Start Upward Trend
03/16/201508:27:08Who Will Be Orexigen's Ex-U.S. Partner? My Bet Is On Takeda
03/15/201520:45:03Orexigen - Contrave Scripts Rise Over 6%, But The Focus Is On...
03/13/201517:44:08Vivus - Qsymia Scripts Pass 11,000 For First Time In 2015
03/11/201508:26:11Arena Scripts Still Slower Than Needed - Are Downgrades In The...
03/10/201502:21:06Novo Nordisk Readies For Saxenda Launch - Investors Need To Keep...
03/10/201502:07:01Arena - Belviq Ads Slow Substantially - Eisai Promises Seem To...
03/09/201510:37:08Orexigen's Contrave Blunder Due To Weak Intellectual Property...
03/04/201517:55:55Statement of Changes in Beneficial Ownership (4)
03/03/201516:26:44Current Report Filing (8-k)
03/02/201520:07:03Arena's (ARNA) CEO Jack Lief on Q4 2014 Results - Earnings Call...
03/02/201516:01:00Arena Pharmaceuticals Provides Corporate Update and Reports Fourth...
03/01/201517:35:17Notable earnings after Mondayâs close

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