Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use ...

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with ...

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

Shipments of the treatment will be suspended effective close of business Tuesday. The decision de-escalates a highly unusual standoff between Sarepta and the FDA over the safety of Elevidys.

Sarepta will continue to ship its gene therapy Elevidys to DMD patients who can still walk independently, the company said in a statement late Friday, citing its own “comprehensive scientific ...

EU panel declines backing Sarepta-Roche gene therapy for Duchenne Jul. 25, 2025 7:15 AM ET Sarepta Therapeutics, Inc. (SRPT) Stock, RHHBY Stock, RHHBF Stock By: Arundhati Sarkar, SA News Editor ...

Sarepta had said its rationale for initially not pulling Elevidys — approved for patients age 4 and older with a confirmed mutation of the Duchenne gene — was because the latest death came ...

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene moxeparvovec-rokl), the marketed Duchenne muscular dystrophy (DMD) treatment ...

Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, in the U.S.

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety concerns mount over the Duchenne muscular dystrophy (DMD) gene therapy.

Shares of Sarepta Therapeutics fell as much as 8% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the ...