Sarepta Therapeutics reported that its long‑awaited ESSENCE confirmatory trial of Vyondys 53 and Amondys 45 failed to meet the primary endpoint, though management signaled it will press the FDA for full approvals based on the totality of evidence. The company attributed some trial problems to COVID‑related missed doses and operational disruptions; excluding pandemic‑affected subjects shifted outcomes but did not reach conventional statistical significance. Sarepta’s shares plunged on the news and management faces decisions about next regulatory steps and the marketed status of its exon‑skipping drugs. The result underscores the risks tied to accelerated approvals contingent on later confirmatory data and will likely prompt closer scrutiny of post‑marketing evidence strategies across sponsors with conditional approvals.