News

FDA, Sarepta Therapeutics and Elevidys

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a voluntary pause.
Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars
Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration (FDA) reversed its request for a voluntary pause late Monday.
Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients
Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) recommended the removal of a voluntary hold for Elevidys.
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 stock sinks further Tuesday after halting shipment of bestselling drug Elevidys
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an unrelated drug.
Death of 8-year-old not tied to Sarepta gene therapy: FDA
The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used for Duchenne muscular dystrophy.
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,
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.
FDA Suspends Sarepta's Gene Therapy Trials After Deaths; But Company Declines ELEVIDYS Shipment Halt
The U.S. Food and Drug Administration announced that it has placed Sarepta Therapeutics' (SRPT) investigational gene therapy trials for limb-girdle muscular dystrophy on
Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid Safety Concerns
The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but paused for non-ambulatory ones.
Sarepta Soars After FDA Says Some Patients Can Get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.
What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?
Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.
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FDA allows distribution of muscular dystrophy drug again after public criticism
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...