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Los Angelas, CA -- (SBWIRE) -- 02/28/2013 -- Zogenix Inc. (NASDAQ:ZGNX), the drugmaker seeking to bring the first pure hydrocodone painkiller to market, rose the most ever on increased investor expectations of U.S. regulatory approval.
Zogenix, Inc. was the biggest gainer on the NASDAQ after surging 40.5 percent on volume of 11.32 million shares traded Wednesday, after jumping 55 percent for the largest intraday increase since the company first sold shares to the public in November 2010. The stock fell 51 percent in the year through yesterday.
The Food and Drug Administration said it will miss a March 1 deadline to decide whether to approve the painkiller, called Zohydro, because the agency needs more time to review data, according to a statement yesterday from San Diego-based Zogenix. Analysts at Leerink Swann & Co. and Wells Fargo Securities LLC said the delay indicates the drug likely will be approved.
FDA advisers in December recommended that Zohydro shouldn’t be approved until regulators examined greater measures to curb opioid abuse. The pill would be the first pure hydrocodone painkiller, as opposed to combination treatments like the acetaminophen-mixed Vicodin. The FDA isn’t obligated to follow the recommendations made by advisory panels.
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