PTCT investors may receive additional information about the case by clicking the link "Join this Class Action" above.
According to the complaint, PTCT is a biopharmaceutical company focused on the discovery, development and commercialization of orally administered, small molecule therapeutics targeting an area of ribonucleic acid (“RNA”) biology, known as post-transcriptional control.
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..
If you are a member of the class described above, you may no later than May 2, 2016 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at email@example.com. For more information about Kessler Topaz Meltzer & Check, LLP, please visit our website at http://www.ktmc.com. If you would like additional information about the suit, please fill out the attached form as promptly as possible and return it by fax to 610-667-7056, or by mail in the enclosed envelope.
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
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Radnor, PA 19087 1-888-299-7706 (toll free) or 1-610-667-7706
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