An investigation for investors in Sarepta Therapeutics Inc (NASDAQ:SRPT) shares over potential securities laws violations by Sarepta Therapeutics was announced and NASDAQ:SRPT stockholders should contact the Shareholders Foundation.
San Diego, CA -- (SBWIRE) -- 05/04/2016 -- An investigation was announced for investors of Sarepta Therapeutics Inc (NASDAQ:SRPT) shares over potential securities laws violations by Sarepta Therapeutics in connection certain financial statements was announced.
Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) declined to as low as $8.00 per share on April 26, 2016.
Investors who purchased shares of Sarepta Therapeutics Inc (NASDAQ:SRPT), have certain options and should contact the Shareholders Foundation at email@example.com or call 858-779-1554.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Sarepta Therapeutics Inc (NASDAQ:SRPT) concerning whether a series of statements by Sarepta Therapeutics regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
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 January 15, 2016, the FDA published a statements on its web site the FDA Briefing Information by an agency advisory committee to review the New Drug Application filed by Sarepta Therapeutics, Inc. for eteplirsen as a treatment for Duchenne muscular dystrophy. The agency's internal review of eteplirsen stated, in part, that "[a]lthough FDA is prepared to be flexible with respect to a devastating illness with no treatment options, we cannot approve drugs for which substantial evidence of effectiveness has not been established."
On April 25, 2016, Sarepta Therapeutics Inc issued a statemen on the advisory committee outcome for the use of its durg Eteplirsen in the treatment of Duchenne muscular dystrophy. Among other things, Sarepta Therapeutics Inc said that the advisory committee voted 6-7 against the finding of substantial evidence from adequate and well controlled studies that show that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit (FDA Question #2) and that the advisory committee voted 3 – 7, with three abstentions, against finding substantial evidence based on the clinical results of the single historically controlled study (Study 201/202) that eteplirsen is effective for treatment of DMD (FDA Question #7).
Those who purchased shares of Sarepta Therapeutics Inc have certain options and should contact the Shareholders Foundation.
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