REGENXBIO to push for accelerated approval of DMD gene therapy

REGENXBIO touted data from the Phase III portion of a study that showed higher benefit that Elevidys. REGENXBIO touted data from the Phase III portion of a study that showed higher benefit that Elevidys. REGENXBIO will file for accelerated approval of the gene therapy to the FDA. Credit: Sheldon Cooper/SOPA Images/LightRocket via Getty Images REGENXBIO is set to apply for US accelerated approval of its Duchenne muscular dystrophy (DMD) gene therapy after it showed benefit in a Phase III trial. The Phase III portion of the AFFINITY DUCHENNEtrial, (NCT05693142), investigating RGX-202, met its primary endpoint with high statistical significance, with…

Source: Clinical Trials Arena