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July 24, 2026 brought a roughly 24% pre-market drop in Zevra Therapeutics after the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) issued a negative opinion on the Marketing Authorization Application for arimoclomol, branded Meplyffa, for Niemann-Pick disease type C.
The CHMP opinion was announced before regular trading and triggered an immediate selloff in Zevra shares. Financial news reports described the decline as the stock’s worst single-day percentage loss in more than five years. The regulatory decision concerned arimoclomol, Zevra’s lead product for Niemann-Pick disease type C.
Following the CHMP’s negative opinion, Zevra announced that it intends to request a re-examination of the decision and would continue providing arimoclomol to eligible patients through its global Expanded Access Program pending further regulatory review.