On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to ...

(RTTNews) - The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular ...

CHMP issued a negative opinion on Elevidys for Duchenne patients aged 3–7 despite secondary gains in motor function. Elevidys has treated over 900 DMD patients, but EMA and FDA raise concerns over ...

Wedbush upgrades Sarepta Therapeutics, citing overdone selloff and potential upside as FDA could re-approval Elevidys for non ...

WASHINGTON, D.C. — The U.S. Food & Drug Administration announced Friday that it has launched an investigation into the death of an 8‑year‑old boy who received Elevidys, the gene therapy developed by ...

The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ambulatory patients. Last Friday, the FDA said that it will investigate ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET today, the U.S. Food and Drug ...

Sarepta and Hansa formed the partnership in 2020 to determine if Idefirix could broaden the patient population for Elevidys.

The FDA said Nov. 14 it will place its most prominent safety warning on Elevidys, a gene therapy for Duchenne muscular dystrophy, after two fatal cases of acute liver injury. Officials have reported ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA ...

When the FDA reworked the prescribing information for Sarepta Therapeutics' Duchenne muscular dystrophy (DMD) gene therapy Elevidys earlier this month, the company touted a plan to study a regimen ...

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced ...