Sarepta shares sink on 3rd patient death amid restructuring statement
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New York Times
an hour ago
- New York Times
Corrections: July 23, 2025
An article on Sunday about the legal implications of being an organ donor misstated the number of Americans who are in the national donor registry. There are more than 173 million Americans in both state registries and the national registry, not the national registry alone. An article on Monday about the biotech company Sarepta Therapeutics and its distribution of a treatment for a deadly muscle-wasting disease misstated the date that Sarepta halted shipments of Elevidys for non-ambulatory Duchenne patients. Shipments were halted on June 15, not July 15. An article on Tuesday about President Trump urging two professional sports teams to change their names misstated the number of carved figures, known as the Guardians of Traffic, on the Hope Memorial Bridge in Cleveland. There are eight, not two. An obituary on Tuesday about the actor Kenneth Colley misstated the cause of the character Admiral Piett's death in the movie 'Return of the Jedi.' His ship crashes into the Death Star; he is not shot down by a Rebel fighter. Errors are corrected during the press run whenever possible, so some errors noted here may not have appeared in all editions. To contact the newsroom regarding correction requests, please email nytnews@ To share feedback, please visit Comments on opinion articles may be emailed to letters@ For newspaper delivery questions: 1-800-NYTIMES (1-800-698-4637) or email customercare@
Boston Globe
13 hours ago
- Boston Globe
Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
'This proactive step will allow Sarepta the necessary time to respond to any requests for information and allow Sarepta and FDA to complete the Elevidys safety labeling supplement process,' said Sarepta CEO Doug Ingram, in a statement. The decision wasn't entirely in Sarepta's control. On Monday, Children's Hospital Los Angeles (CHLA) said it was pausing use of Elevidys while the drug is in regulatory limbo. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up 'Patient safety is paramount at CHLA and the hospital has communicated its decision with affected patient families while it awaits any further determination by the FDA,' the hospital told STAT. Advertisement Other hospitals that specialize in the treatment of Duchenne patients are reportedly considering similar treatment pauses. Sarepta may have also realized that fighting with the FDA was high-risk. 'It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension,' said Ingram, in the statement. Sarepta did not indicate how long the Elevidys suspension might last. Ritu Baral, a biotech analyst at Cowen, estimated 3 to 6 months. During that time the company would test a proposed immune-suppressing protocol designed to mitigate the serious liver toxicity caused by the gene therapy, and share those data with the FDA. Advertisement In a statement, Parent Project Muscular Dystrophy, a patient advocacy organization, said the FDA demand to halt Elevidys shipments and Sarepta's agreement to do so has 'intensified concerns and uncertainty' for Duchenne patients and their families. 'We deeply value the importance of data-driven decision-making and responsible regulatory oversight. We urge both Sarepta and the FDA to communicate with urgency, clarity, and transparency about the path forward,' the group said. On Friday, the FDA asked Sarepta to pause all shipments of Elevidys following media reports of the death of a 51-year-old man who received a different but related gene therapy for a different form of muscular dystrophy. That death followed the deaths in March and June of two teenagers who received Elevidys. Sarepta had already paused shipments for patients who rely on wheelchairs — boys with Duchenne typically lose the ability to walk around age 12. But the company initially said it would not comply with the FDA's request to also halt shipments for ambulatory patients. To agree would mean a de facto withdrawal of the therapy from the market. But on Monday, the company reversed course. Elevidys has appeared safer and more effective in ambulant Duchenne patients, who are generally younger, but significant side effects can still occur. Scheduled infusions across the country will now be canceled.
Bloomberg
13 hours ago
- Bloomberg
Sarepta's Duchenne Therapy Sparked Fears Even Before FDA's Order
By , Gerry Smith, and Rachel Cohrs Zhang Save There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy. Reports of troubles linked to Sarepta's Elevidys treatment for Duchenne muscular dystrophy had been popping up on social media for months — beyond the two deaths the company had already disclosed — but there was little information from the company or the health regulators that widened availability of the drug over objections from its own staff, according to analysts, FDA records and at least one patient advocate.
