News

Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
The ask comes days after Sarepta, which has a major presence in Columbus, announced it would lay off 500 workers, including 80 in central Ohio. The Food and Drug Administration announced ...
FiercePharma2y
Sarepta pawns off PRV for $102M to unidentified buyer - Fierce Pharma
In 2017, after Sarepta won approval for DMD drug Exondys 51, the company sold the accompanying PRV to Gilead Sciences for $125 million. Then in 2020, after it secured an FDA green light for ...
Yahoo8y
FDA approves Sarepta’s controversial drug for Duchenne ... - Yahoo
The US Food and Drug Administration approved a Sarepta drug to treat Duchenne muscular dystrophy that it had rejected in April as ineffective.
FierceBiotech2y
FDA skips AdComm for Sarepta's DMD therapy, sets decision date
The FDA won’t be holding an advisory panel meeting for Sarepta Therapeutics’ SRP-9001, which is now that much closer to becoming the first gene therapy for Duchenne muscular dystrophy (DMD).
Benzinga.com2y
FDA Staff Raises Issues For Sarepta's Duchenne Gene Therapy Data ...
The FDA's Cellular, Tissue and Gene Therapies Advisory Committee is meeting this Friday to discuss Sarepta Therapeutics Inc's (NASDAQ: SRPT) to review SRP-9001 (delandistrogene moxeparvovec ...
Seeking Alpha5y
Sarepta Versus The FDA, And Other News: The Good, Bad And Ugly Of ...
Sarepta Therapeutics (NASDAQ:SRPT) fell victim to the FDA's whims as the stock tumbled more than 3 percent following the issues raised by the FDA against its drug candidate Vyondys 53 ...
FierceBiotech2y
In a U-turn, FDA orders AdComm for Sarepta's DMD gene therapy
At the end of last month, Sarepta told investors it had completed the midcycle review for the SRP-9001 submission, and, with no significant safety or clinical issues coming up, the FDA had ...
FiercePharma2y
FDA's Marks went against reviewers' call on Sarepta's Elevidys
The FDA's review teams were moving against an approval of Sarepta's Duchenne muscular dystrophy gene therapy. But Peter Marks, M.D., Ph.D., who oversees the agency's review of gene therapies ...
MarketWatch5y
Sarepta stock falls on FDA concerns about drug - MarketWatch
Sarepta Therapeutics Inc. shares fell in the extended session Monday after the drug maker said the Food and Drug Administration raised concerns about its muscular dystrophy treatment. Sarepta ...
Las Vegas Sun2d
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators ...