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FDA, Sarepta and gene therapy

BioPharma Dive · 1h

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

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Fierce Pharma · 6h

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

· 2d · on MSN

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

2d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

Sarepta Stands Ground Against HHS Request to Stop Elevidys Shipments

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...

Zacks Investment Research on MSN5h

SRPT Down After Third Death in Muscular Dystrophy Gene Therapy Program

Shares of Sarepta Therapeutics SRPT nosedived 35.9% on Friday following the death of a patient dosed with one of its ...

3hon MSN

Sarepta shares cut to $0 at H.C. Wainwright

H.C. Wainwright has taken the unusual step of setting a $0 price target for troubled biotech Sarepta Therapeutics ...

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