BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that it is investigating potential claims on behalf of investors of Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ:SRPT). The investigation concerns possible violations of federal securities laws and focuses on certain statements issued by the Company between April 21, 2014 and October 27, 2014, concerning Sarepta’s operations and financial prospects.
Sarepta is a biopharmaceutical company, engaged in the discovery and development of RNA-based therapeutics for the treatment of rare and infectious diseases. Its lead product candidate is eteplirsen, an antisense PMO-based therapeutic in clinical development for the treatment of Duchenne muscular dystrophy. The investigation is related to the Company’s October 27, 2014, announcement of a regulatory update concerning the Company’s discussions with the U.S. Food and Drug Administration related to Sarepta’s planned New Drug Application (NDA) submission for approval of eteplirsen for the treatment of Duchenne muscular dystrophy.
According to the Company, 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’s 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. 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. As part of an NDA submission, the FDA is further requesting, among other things:
- Three-month data from at least 12 to 24 newly exposed patients at the time the NDA is submitted.
- 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.
- Additional data from later time points and from newly enrolled patients, submitted in the 120-Day Safety Update.
The FDA indicated that further discussion with Sarepta “will be necessary to determine what would constitute a complete NDA.” Following this news, Sarepta shares declined more than 32%, or $7.65 per share, to close at $15.91 per share on October 27, 2014, on volume of more than 15 million shares.
If you purchased Sarepta shares between April 21, 2014 and October 27, 2014, if you have information or would like to learn more about these claims, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.