Sarepta, FDA
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Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.
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BMO's Kostas Biliouris: It will be challenging for the FDA to force a market withdrawal for Sarepta
Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on Sarepta after the company declined the FDA's request to halt shipments of its gene therapy.
As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we never asked to join — said goodbye to their sons, the babies they once held in their arms, whose dreams they held in their hearts until Duchenne robbed them of working muscles or a healthy future.
Key Takeaways Sarepta Therapeutics shares were down nearly 25% early Friday morning.The tumble followed a report that a third patient has died during a clinical trial for its Elevidys drug that treats muscular dystrophy.