Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene 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 ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

Sarepta Therapeutics, Inc. SRPT stock experienced a steep decline of approximately 40% in premarket trading on Monday following a sobering safety update for its Duchenne muscular dystrophy (DMD ...

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

WASHINGTON (AP) — Shares of Sarepta Therapeutics plunged Monday after the biotech drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. Sarepta reported ...

Sarepta has submitted a request to the FDA to include the death case in Elevidys’ label, and the agency plans to review the situation by the end of the year, Sarepta’s R&D chief, Louise Rodino ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. Adam Feuerstein is ...

Sarepta noted that the FDA had proactively asked if the company has considered using additional immunosuppression, including sirolimus, suggesting that a complete restriction in this population ...

Sarepta Therapeutics SRPT announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, used in the investigational gene therapy SRP-9003.