Sarepta reported that its confirmatory ESSENCE trial of exon‑skipping antisense oligonucleotide therapies failed to meet the primary endpoint, a result the company attributed in part to pandemic‑era missed doses among participants. The miss prompted a sharp stock decline and intensified scrutiny over the durability of accelerated‑approval pathways tied to surrogate measures. Analysts and investors criticized the company’s quarter and management narrative, highlighting revenue misses, confirmatory gaps and the resulting strategic uncertainty. Sarepta said it will engage regulators to discuss the path forward but stopped short of expecting immediate label changes. The episode raises questions about confirmatory trial design sensitivity, real‑world disruptions, and regulatory expectations for accelerated approvals — issues that could affect other developers relying on surrogate endpoints.