|Clinical and Regulatory|
|Designation(s):||Fast Track, Orphan Drug, Priority Review, Rare Pediatric Disease|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Indication:||Duchenne Muscular Dystrophy|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Sarepta Therapeutics|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for eteplirsen has been extended to May 26, 2016.