SAN FRANCISCO, April 04, 2016 (GLOBE NEWSWIRE) -- Hagens Berman Sobol Shapiro LLP, a national investor-rights law firm reminds PTC Therapeutics (Nasdaq:PTCT) investors of the May 2, 2016 lead plaintiff deadline in the securities fraud class action lawsuit against PTCT.
If you suffered losses because of your purchases of PTCT between May 6, 2014 and February 29, 2016, or have information that will help our investigation contact Hagens Berman Partner Reed Kathrein, who is leading the firm’s investigation by calling 510-725-3000, emailing PTCT@hbsslaw.com or visiting https://www.hbsslaw.com/cases/PTCT. The lawsuit was filed in the U.S. District Court for the District of New Jersey and investors have until May 2, 2016 to move the court to participate as a lead plaintiff.
The complaint alleges Defendants failed to disclose: (1) the Translarna™ NDA was not sufficiently complete to permit the FDA to substantively review it; (2) as such, the FDA would not substantively review or approve the NDA; (3) non-approval of the NDA would negatively and materially impact PTCT’s operations and prospects; and (4) that, as a result of the foregoing, Defendants’ statements about PTCT’s business, operations, and prospects were false and misleading. On February 23, 2016 PTCT announced it received a Refuse to File letter from the United States FDA regarding PTCT's Translarna™ NDA.
When truth about the incomplete NDA was revealed on February 23, 2016, the price of PTCT stock price declined over 60%, closing at $10.84 per share that day.
On February 29, 2016, PTCT disclosed more details about the Refuse to File letter: (1) both the Phase 2b and ACT DMD trials were negative and do not provide substantial evidence of effectiveness; (2) the FDA “certain of the company’s adjustments to the ACT DMD study as post hoc and therefore not supportive of effectiveness;” and (3) “the NDA did not contain adequate information regarding the abuse potential of Translarna, a requirement for new molecules that cross the blood-brain barrier.”
As a result, on February 29, 2016, shares of PTC’s stock declined an additional $2.43 per share, or over 30%, to close on March 1, 2016 at $5.55 per share.
Whistleblowers: Persons with non-public information regarding PTC Therapeutics should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new SEC whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 510-725-3000 or email PTCT@hbsslaw.com.
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