The Shareholders Foundation announces that an investor, who purchased shares of Sarepta Therapeutics Inc (NASDAQ:SRPT), filed a lawsuit in the U.S. District Court for the District of Massachusetts over alleged violations of Federal Securities Laws by Sarepta Therapeutics in connection with certain allegedly false and misleading statements made between April 21, 2014 and October 27, 2014.
Investors who purchased shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) have certain options and for certain investors are short and strict deadlines running. Deadline: February 9, 2015. NASDAQ:SRPT investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of purchasers of Sarepta Therapeutics Inc (NASDAQ:SRPT) common shares between April 21, 2014 and October 27, 2014, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that defendants made allegedly false and/or misleading statements and/or allegedly failed to disclose to investors that Sarepta Therapeutics Inc failed to provide sufficient data for its New Drug Application (“NDA”) submission for marketing approval of eteplirsen, that as a result, Sarepta Therapeutics Inc’s NDA for eteplirsen would likely be filed in mid-2015, rather than the end of 2014, and that, Sarepta Therapeutics Inc’s statements about its business, operations and prospects, including statements about eteplirsen’s prospects for FDA approval for the treatment of Duchenne muscular dystrophy, were materially false and misleading and/or lacked a reasonable basis.
On October 27, 2014, Sarepta Therapeutics Inc announced a regulatory update on Eteplirsen concerning Sarepta Therapeutics’ discussions with the U.S. Food and Drug Administration (“FDA) related to Sarepta Therapeutics’ planned New Drug Application (“NDA”) submission for approval of Eteplirsen for the treatment of Duchenne muscular dystrophy. According to Sarepta Therapeutics, following a Pre-NDA meeting in September 2014, the FDA provided updated guidance regarding the specific data to be included as part of, or at the time of, Sarepta Therapeutics’ NDA submission, stating that additional data are required as part of the NDA submission, including the results from an independent assessment of dystrophin images and the 168-week clinical data from study 202. Sarepta Therapeutics also said that in addition, the guidance requests more specific data, including a minimum duration of safety in new patients exposed to eteplirsen, patient-level natural history data to be obtained by Sarepta from independent academic institutions, and MRI data from a recent study conducted by an independent academic group. Sarepta Therapeutics said that as part of an NDA submission, the FDA is further requesting, among other things that three-month data from at least 12 to 24 newly exposed patients at the time the NDA is submitted, that available data from the other patients enrolled in the new eteplirsen studies (studies 301, 203, 204), even if exposure is less than 3 months in duration, and that additional data from later time points and from newly enrolled patients, submitted in the 120-Day Safety Update. On October 27, 2014, Sarepta Therapeutics Inc shares declined to as low as $14.74 per share.
On January 2, 2015, NASDAQ:SRPT shares closed at $14.94 per share.
Those who purchased shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com