Sarepta Patient Deaths Investigation

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FDA, Sarepta and gene therapy

Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% as company halts non-ambulatory patient treatments.

BioPharma Dive · 2d

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.

Invezz on MSN · 5d

Sarepta shares fall 37% as FDA questions future of key gene therapy

Shares of Sarepta Therapeutics fell close to 37% on Friday after reports emerged that the US Food and Drug Administration is considering whether to halt the distribution of Elevidys, the company’s flagship gene therapy for Duchenne Muscular Dystrophy (DMD).

BioSpace1d

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

2don MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

BioSpace7d

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.

Stocktwits on MSN2d

GlucoTrack, Sarepta, TNF Pharma Dominate Weekly Retail Health Care Buzz — Here’s Why

Retail chatter spiked last week as investors piled into three healthcare stocks: GlucoTrack, Sarepta Therapeutics, and TNF ...

STAT1d

Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...

The Business Journals1mon

FDA says it's investigating Sarepta’s Duchenne patient deaths

The Food and Drug Administration is conducting an investigation following the deaths of two patients treated with Sarepta's gene therapy for Duchenne muscular dystrophy. Thursday, July 31, ...

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