In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.

Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, sending the company's shares 59% higher in extended trading.

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by safety concerns.