The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announced a negative opinion on Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys, citing insufficient evidence of clinical benefit in placebo-controlled trials for ambulatory children. In contrast, the CHMP reversed its earlier rejection of Eli Lilly’s Alzheimer's drug Kisunla (donanemab), now recommending approval for patients who are ApoE4 heterozygotes or non-carriers. These decisions highlight ongoing regulatory scrutiny and evolving standards for novel therapies in neurodegenerative and genetic disorders.