NEW YORK, March 14, 2016 (GLOBE NEWSWIRE) -- Wolf Popper LLP has filed a class action lawsuit against PTC Therapeutics, Inc. (NASDAQ:PTCT), and certain of its officers, in the United States District Court for the District of New Jersey, on behalf of all persons who purchased PTC securities on the open market and/or pursuant to a Registration Statement, during the period May 7, 2014 through February 29, 2016, and were damaged thereby. This action alleges claims for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
If you are a member of the Class, you may file a motion no later than May 2, 2016 to be appointed a lead plaintiff. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Investors who purchased PTC securities during the Class Period and suffered losses are urged to contact Wolf Popper to discuss their rights.
The Complaint charges that during the Class Period, defendants issued a series of false and misleading statements that misrepresented that PTC’s new drug application (“NDA”), for its lead product candidate Translarna, was on track for review by the U.S. Food and Drug Administration. Defendants represented that Translarna “was efficacious” and that the “totality of the clinical data from two large, placebo-controlled clinical trials across over 400 patients demonstrate Translarna’s ability to slow disease progression.”
Defendants failed to disclose, among other things, that the: (i) NDA was not sufficiently complete to permit a substantive review by the FDA as PTC failed to provide substantial scientific evidence of Translarna’s effectiveness; (ii) retrospective subgroup analysis in the Phase 2b trial failed to demonstrate efficacy; and (iii) Company made a post hoc adjustment in its Phase 3 trial by eliminating data from a majority of enrolled patients.
On February 23, 2016, PTC disclosed that it had received a Refusal to File letter, which stated that the “application was not sufficiently complete to permit a substantive review.” On this disclosure, PTCT shares declined $17.42 per share or 62%.
On February 29, 2016, PTC’s CEO further revealed that, according to the FDA, the Company did not provide substantial scientific evidence of effectiveness as it eliminated “data from a majority of enrolled patients.” As a result, PTCT shares declined an additional $2.43 per share or 30% on March 1, 2016.
Wolf Popper has successfully recovered billions of dollars for defrauded investors. The firm’s reputation and expertise have been repeatedly recognized by the courts, which have appointed the firm to major positions in securities litigation. See www.wolfpopper.com
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