The firm said the clinical trial pause is temporary as an independent data monitoring committee finalizes its analysis for submission to regulators.

Sarepta (SRPT) and Roche (RHHBY) expect to submit data to address a clinical hold imposed on Elevidys, a gene therapy for ...

Therapeutics shared the following update related to ELEVIDYS, the only approved gene therapy in patients with Duchenne muscular ...

Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved ...

Healthcare Analysts, along with Dr. Yaacov Anziske of SUNY Downstate, discuss Sarepta’s (SRPT) ELEVIDYS and the future of Duchenne Muscular ...

Doing more to incorporate caregiver burden into value assessments and cost-effectiveness research of Duchene muscular dystrophy treatments was the focus of a recent International Society for ...

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...

The European Medicines Agency asked for three clinical trials to be placed on hold until the exact cause of death of a US ...

Sarepta stock tumbled Thursday after European officials put all studies of the company's gene therapy, Elevidys, on hold.

As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and ...

Dr. Marks was asked to leave and then subsequently wrote that he did not want to become “subservient to [Secretary Kennedy’s] misinformation and lies.” Peter Marks is not a hero of the resistance but ...