Three ongoing clinical trials of ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy developed by Sarepta and marketed by Roche, have been temporarily halted by the European Medicines Agency (EMA). This expected but not unwelcome news has caused deep sadness in the Duchenne muscular dystrophy (DMD) community.
Before Roche, Sarepta and EMA the first community to publish this announcement was our Turkish partner >>> DMD Dayanisma.
Roche has issued a letter to the community which you can read here. (PDF)
Table of Contents
Why Were Elevidys Clinical Trials Halted?
After the death of a 16-year-old boy with Duchenne muscular dystrophy who received an infusion of Elevidys on March 18, 2025, the outlook for the gene therapy, which is marketed at a commercial price of $3 million, changed abruptly. (Read More)
SRP-9001-104 Temporarily Halted
Source: Clinical Trial of SRP-9001-104
ENVOL (Study 302) Temporarily Halted
Source: Clinical Trial of SRP-9001-302
SRP-9001-303 Temporarily Halted
Source: Clinical Trial of SRP-9001-303
Learn More: DMD WarrioR’s Turkish Representative Shares His Views on Elevidys Gene Therapy.
