Sarepta Elevidys Safety Concerns

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Sarepta Soars

Sarepta Soars After FDA Says Some Patients Can Resume Elevidys

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.

Invezz on MSN · 5h

Sarepta shares soar 36% after FDA clears partial resumption of Elevidys shipments

Sarepta Therapeutics shares jumped over 36% in premarket trading on Tuesday after the company said it had received US Food and Drug Administration (FDA) approval to restart shipments of its flagship gene therapy Elevidys in the United States.

Yahoo · 19h

FDA allows Sarepta to resume some Elevidys shipments

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

Fierce Pharma1d

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

Sarepta: SRPT Stock To $40?

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

pharmaphorum6h

FDA gives the go-ahead to restart Elevidys shipments

In a statement, the Cambridge, Massachusetts-based company said that shipments of Elevidys (delandistrogene moxeparvovec) will restart while it continues dialogue with the FDA "on next steps in the ...

Devdiscourse6d

Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

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