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Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
Sarepta Therapeutics said on Monday it will resume shipping of its gene therapy Elevidys to patients with a rare muscular ...
Sarepta Therapeutics ( NASDAQ: SRPT) was upgraded to Neutral from Underweight at J.P. Morgan as it sees FDA's Elevidys hold removal recommendation in ambulatory patients as a clear win.
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.
Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...