Sarepta FDA Regulatory Hold - Search News

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Sarepta, FDA and Gene Therapy

BioPharma Dive · 2d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

InvestorsHub on MSN · 2d

Sarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular Dystrophy

Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug Administration (FDA) has imposed a clinical hold on several of its gene therapy programs targeting limb girdle muscular dystrophy (LGMD).

Yahoo Finance · 2d

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

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments.

Fierce Biotech2d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

Stocktwits on MSN1d

Sarepta Pauses Shipments Of DMD Drug Elevidys Amid FDA Label Review, Stock Tumbles After-Hours

Sarepta Therapeutics shares closed over 5.3% lower on Monday, hitting more than a nine-year low, and fell another 8.5% in ...

2d

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

Sarepta resists as FDA seeks pause on Elevidys use

Sarepta has refused to suspend all dosing of its gene therapy for Duchenne muscular dystrophy, Elevidys, defying a clinical ...

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 ...

2d

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

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