Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...

Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Sarepta faces competition in the gene therapy space from companies like Avidity Biosciences and Dyne Therapeutics, which are developing their own approaches to treating muscular dystrophies.

Serepta and global partner Roche have discontinued the commercial and clinical use of Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec) in non-ambulatory ...

Sarepta halts Elevidys shipments for non-ambulatory DMD patients after a second patient death in three months post gene therapy treatment.

Sarepta Therapeutics SRPT announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, used in the investigational gene therapy SRP-9003.

In March, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy ...

Key Takeaways A patient died from liver injury while taking the gene therapy Elevidys Sarepta says more than 800 patients have received the treatment The company plans to update prescribing ...

Shares of Sarepta Therapeutics have struggled for the past year due to concerns about the commercial potential of its gene therapy and broader pipeline. Safety hadn’t been a major worry for ...