Acura Pharmaceuticals, Inc.
Class Period: Feb 21, 2006 to Apr 22, 2010
Lead Plaintiff Deadline: Nov 9, 2010 + Deadline passed
Summary of Case:
A securities class action has been filed against Acura Pharmaceuticals, Inc. (ACUR) ("Acura" or the "Company") on behalf of all securities purchasers from February 21, 2006 through April 22, 2010, inclusive ("Class Period"), in the United States District Court for the Northern District of Illinois.
The complaint alleges that during the Class Period, Acura and certain of its officers and directors concealed material adverse facts about the Company's lead product candidate, Acurox, an orally administered immediate release tablet containing oxycodone as its active ingredient and niacin as an oral abuse-deterrent. After repeated glowing announcements by Acura to its investors touting the strength of the clinical trials of Acurox and the drug's potential for obtaining FDA approval, and thus commercial viability, the market was stunned when, on April 20, 2010, the FDA posted, on its website, briefing materials for the April 22, 2010 meeting to consider the New Drug Application of Acurox advising that: Acura's Aversion Technology was nowhere near effective enough to warrant approval, that the Company's clinical data was defective, that its clinical studies were not properly designed, that the Company had wholly ignored specific directives from FDA over the past four years as to specific clinical trials and evidence Acura had to demonstrate, and that that no evidence had ever been presented to the FDA that the niacin additive discouraged abusers from abusing oxycodone.
On this news, Acura's stock price declined 42.5% in one day, to close at $6.25 in afterhours trading. On April 22, 2010, the FDA Joint Panel voted 19-1 against approving Acurox. On the same day, it was reported that the FDA had been prodding Acura to demonstrate the deterrent efficacy of niacin since at least May 2009. As a result of these disclosures, Acura's stock price declined 39%, to $3.20 per share, in the pre-market trading on April 23, 2010.
If you purchased this company's shares during the Class Period and suffered a loss or for further information about the case, please review the links below.