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Sarepta, Elevidys and FDA

· 1h · on MSN

FDA Says Sarepta Can Resume Gene Therapy in Some Patients

In a major win for Sarepta Therapeutics Inc., US regulators are recommending that patients who can walk be allowed to take its gene therapy Elevidys again.

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· 1h · on MSN

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients

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Parents urge FDA to restore gene therapy after distribution pause

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

9h

Parents call on FDA for path forward after Duchenne's gene therapy pause | Morning in America

The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

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Sarepta rises 2%; Barclays downgrades to underweight on liquidity and Elevidys concerns

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

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'We will crack gene therapy': Elevidys fallout doesn't dent Roche's hopes for modality

Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...

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Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

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Food and Drug Administration

Duchenne muscular dystrophy

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