Tag Archives: ELEVIDYS

By Bhanvi Satija and Siddhi Mahatole (Reuters) -Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for its muscular gene therapy soothes immediate concerns about liquidity and the therapy’s withdrawal from the market. The company said on Monday it would resume shipments of Elevidys — approved in the U.S. to treat a …

Investing.com — The U.S. Food and Drug Administration has recommended lifting the voluntary hold on Sarepta Therapeutics (NASDAQ:SRPT)’ gene therapy Elevidys for ambulatory patients with Duchenne Muscular Dystrophy (DMD). The FDA concluded that the death of an 8-year-old boy was unrelated to the gene therapy product itself, allowing ambulatory patients to once again receive the treatment. However, the voluntary hold …

For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). The FDA’s investigation has concluded that the death of the 8-year-old boy is unrelated to the gene therapy product itself .   …

Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS  Sarepta Therapeutics The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear  statnews.com FDA probes death of patient on Sarepta’s Elevidys, partner Roche says death unrelated to therapy  Reuters ‘We will crack gene therapy’: Elevidys fallout doesn’t dent Roche’s hopes for modality  Fierce Biotech FDA weighs new study requirements for Sarepta to confirm …

The uncertainty around the future of Elevidys hasn’t destroyed Roche’s belief in the potential of gene therapies, the Swiss company’s head of pharma has told Fierce Biotech, as the pharma continues to expand its research reach outside of its traditional oncology focus. Roche and its partner Sarepta Therapeutics both paused trials of Elevidys back in April following the death of a 16-year-old …

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. Sarepta Therapeutics, the maker of a gene therapy for Duchenne …

Thomas Fuller | SOPA Images | Lightrocket | Getty Images Sarepta Therapeutics said on Monday that it will pause all shipments of its Elevidys gene therapy in the United States after a muscular dystrophy patient who received a different, experimental treatment died. U.S. regulators on Friday asked Sarepta Therapeutics to voluntarily halt shipments of its gene therapy. However, the company …

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. Sarepta Therapeutics said Monday evening it will pause all shipments …

Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.  Sarepta Therapeutics In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy  statnews.com Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy  Fierce Biotech Sarepta shares plunge 40% as future of its gene therapy appears at risk  CNBC Sarepta Therapeutics stock sinks …

Sarepta plans Elevidys shipments despite FDA request (SRPT)  Seeking Alpha Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths  fda.gov We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress  statnews.com Sarepta …