gene therapy duchenne muscular dystrophy

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FDA asks Sarepta to stop shipping gene therapy

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· 5h

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

Facing mounting criticism, Sarepta recently announced plans to add a bold warning label to Elevidys.

· 22h · on MSN

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

MedPage Today on MSN · 2d

Duchenne Gene Therapy Will Undergo Changes After Patient Deaths

· 1d

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

· 1d

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

· 1d

Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys

Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

STAT · 1d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

· 1d

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

STAT1dOpinion

We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress

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.

1don MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies.

Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

Muscular Dystrophy News2d

Dosing begins in gene therapy trial for DMD-linked heart disease

The first patient has been dosed in a clinical trial testing Sardocor's one-time gene therapy for cardiomyopathy associated with Duchenne MD.