Sarepta Therapeutics, Inc.
Robbins Arroyo LLP Is Investigating the Officers and Directors of Sarepta Therapeutics, Inc. (SRPT) on Behalf of Shareholders
Robbins Arroyo LLP is investigating whether certain officers and directors of Sarepta Therapeutics, Inc. (NASDAQGS: SRPT) breached their fiduciary duties to shareholders. Sarepta is a biopharmaceutical company that develops RNA-based therapeutics for the treatment of rare and infectious diseases.
Sarepta Suffers Setback Following FDA Meeting
On October 27, 2014, shares of Sarepta dropped over 32%, or $7.65 per share, to close at $15.91 on the news that the U.S. Food and Drug Administration (FDA) met with the company in September 2014 and will require Sarepta to provide additional information when submitting the New Drug Application (NDA) that would approve eteplirsen to treat Duchenne muscular dystrophy. This setback is not the first for the company. In November 2013, Sarepta was forced to postpone filing an NDA for eteplirsen after a similar meeting where the FDA stated that an NDA filing would be premature. On that news, Sarepta stock fell 64%.
The September 2014 meeting resulted in the FDA requiring independent assessment of the 168-week clinical data and recent MRI data. Additionally, the FDA is requiring independent verification of patient-level natural history data and specific data regarding a minimum duration of safety in new patients exposed to eteplirsen. The FDA issued a statement on October 30, 2014, expressing concern with the clinical trial site and the timing for submitting trial data. Sarepta now plans on submitting an NDA by mid-2015, pending additional requests from the FDA.
Sarepta Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.