Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

While MSN reports that Sarepta’s stock price began to rise on Monday on the heels of the announcement, 5 the company is still facing challenges. Shipments of the gene therapy for non-ambulatory ...

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

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

Sarepta's ELEVIDYS faces a critical FDA decision; an expanded label could significantly widen market reach, targeting all DMD patients. Strong Q3 performance with impressive revenue and EPS ...

The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...