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Sarepta Therapeutics (NASDAQ:SRPT) announced Friday it intends to submit a Biologics License Application (BLA) seeking accelerated approval for SRP-9001.
Sarepta shares rallied over 9% on the news.
The company is seeking approval for the investigational gene therapy developed in partnership with Roche to treat individuals with Duchenne muscular dystrophy.
SRP-9001 was granted Fast Track designation in July 2020. It has also been granted Rare Pediatric Disease (RPD) designation in the United States and Orphan Drug status in the United States, the European Union, Switzerland, and Japan.
Reacting to the news, a Cowen analyst maintained an Outperform rating and $114 price target on the stock, telling investors they are conservatively putting the current probability of approval at 50/50.
However, “given the seniority of FDA leadership (across centers) that appears to support the reviewability of SRPT’s BLA and the tenor of agency conversation and written communications, we think an RTF is highly unlikely,” said the analyst. “Moving up ‘9001 revenues from our 2024 estimates to 2023 would add only $2 to our target but could pull break-even up to 2023. Given our 50/50 probability, we are currently not updating our methodology.”
