Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

Sarepta reported this event to FDA on June 18, 2025, via the FDA’s postmarketing electronic database, FAERS. At Sarepta, patient safety and well-being are always our top priority.

In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its gene therapy, Elevidys. Read more here.

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 ...

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third ...

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report By Fraiser Kansteiner Jul 24, 2025 3:12pm Sarepta Sarepta Therapeutics Elevidys U.S. FDA ...

Needham, Mizuho and Leerink all downgrade Sarepta stock and slash price targets FDA action on Elevidys could impact Sarepta's ability to meet its 2027 debt. The market’s back, and these 3 income ...

Sarepta initially refused to play ball with the FDA's request, citing its own “comprehensive scientific interpretation of the data,” but it's now changing course.