Sarepta FDA Regulatory Hold

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Sarepta, FDA and Gene Therapy

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 · 3d

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

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

· 1d

InnovationRx: Sarepta Blinks In Showdown With FDA

The latest twist in the saga followed a decision by Children’s Hospital Los Angeles to halt use of the drug while it was facing regulatory uncertainty.

· 2d

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

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Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

Fierce Biotech3d

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 muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.

Stocktwits on MSN3d

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 after-hours trading after the biotech firm announced a voluntary halt to U.S.

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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

pharmaphorum3d

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 hold request from the FDA.

4don 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 gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

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

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

Nasdaq2y

Sarepta (SRPT) Stock Down, FDA to Hold Panel Meet for SRP-9001 - Nasdaq

Shares of Sarepta Therapeutics SRPT plunged almost 20% on Mar 16, soon after the company announced the FDA's decision to hold an unexpected advisory meeting for the biologics license application ...