|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
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review Sarepta’s New Drug Application (NDA) for eteplirsen on April 25, 2016. The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the eteplirsen is May 26, 2016.
The FDA has granted eteplirsen Priority Review status, which is designated for drugs which provide a treatment where no adequate therapy exists. The FDA also granted Rare Pediatric Disease Designation to eteplirsen, as well Orphan Drug Designation and Fast Track Status.