INVESTOR ALERT: Class Action Lawsuit Against Sarepta Therapeutics, Inc. Announced by Law Offices of Howard G. Smith

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of purchasers of the securities of Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ:SRPT) between April 21, 2014 and October 27, 2014, inclusive (the “Class Period”).

Sarepta is engaged in the discovery and development of RNA-based therapeutics for the treatment of rare and infectious diseases. The Company’s lead product candidate is eteplirsen, which is in clinical development for the treatment of Duchenne muscular dystrophy.

The Complaint alleges that defendants made false and/or misleading statements and/or failed to disclose to investors that: (1) the Company failed to provide sufficient data for its New Drug Application (“NDA”) submission for marketing approval of eteplirsen; (2) as a result, the Company’s NDA for eteplirsen would likely be filed in mid-2015, rather than the end of 2014; and (3), the Company’s statements about Sarepta’s 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, the Company announced a regulatory update concerning discussions with the U.S. Food and Drug Administration related to Sarepta’s NDA for eteplirsen. According to the Company, following a Pre-NDA meeting in September 2014, the FDA provided updated guidance regarding additional data required as part of, or at the time of, the NDA submission, including:

  • minimum duration of safety in new patients exposed to eteplirsen;
  • patient-level natural history data from independent academic institutions; and
  • MRI data from a recent study conducted by an independent academic group.

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 are a member of the Class described above, you have until February 6, 2015, to move the Court to serve as lead plaintiff, if you meet certain legal requirements. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If wish to learn more about this action, 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 howardsmith@howardsmithlaw.com, or visit our website at http://www.howardsmithlaw.com.

Contacts:

Law Offices of Howard G. Smith
Howard G. Smith, Esquire
215-638-4847
888-638-4847
howardsmith@howardsmithlaw.com
www.howardsmithlaw.com

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