The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), ...

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

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

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 ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

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

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

I recommended holding Sarepta stock due to the uncertainty associated with drug approvals and clinical trials. Recent developments: Sarepta Therapeutics reported Q2 earnings with a Non-GAAP EPS of ...

The Food and Drug Administration’s (FDA) decision to approve the label expansion of Elevidys to include all Duchenne muscular dystrophy (DMD) patients aged 4 years and older is a pivotal moment ...

– FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients – Sarepta will host an investor conference call on June 21, 2024, at 8:30 a.m. ET ...

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 ...