News

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...
Sarepta Sinks as Third Patient Death Stirs Transparency Concerns
A third patient has died this year after getting a gene therapy from Sarepta Therapeutics Inc., raising questions about the ...
FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Patient dies in Sarepta gene therapy trial, adding to safety concerns
The death will likely further stoke safety concerns around Sarepta's gene therapies, as well as raise questions around the ...
Sarepta to cut 500 jobs, add black-box warning on gene therapy
Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients ...
Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting
The drastic cost-cutting move follows the deaths of two teenagers that forced the company to restrict usage of its gene therapy for Duchenne muscular dystrophy.
Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures
The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
Biotech pauses trial after second patient death linked to gene therapy
Sarepta Therapeutics said a second patient had died after receiving its $3.2 million gene therapy to treat Duchenne muscular dystrophy.
Sarepta Therapeutics to Restructure, Lay Off 500 Workers
The restructuring involves laying off about 500 employees, which is estimated to save $120 million in annual costs in 2026. This year, Sarepta expects to save about $100 million, net of estimated ...