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