Sarepta FDA Regulatory Hold

Order byBest matchMost fresh

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 · 2d

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

· 2d

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

· 5h

InnovationRx: Sarepta Blinks In Showdown With FDA

Last week, in a remarkable showdown, Sarepta Therapeutics refused to stop distribution of Elevidys, its therapy for the muscle-wasting disease Duchenne muscular dystrophy as the FDA had requested.

· 1d

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

STAT · 1d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

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

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

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.

pharmaphorum2d

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.

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

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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