The Committee for Medicinal Products for Human Use (CHMP) recommended approval for Minoryx Therapeutics’ ALD drug, while issuing a negative opinion for Zevra Therapeutics’ Meplyffa in Europe. The split outcome marks a regulatory bright spot for Minoryx after the asset cleared multiple hurdles, and it adds a second European setback for Zevra despite the drug’s US approval roughly two years earlier. For ALD, the CHMP recommendation supports Minoryx’s continued path toward a European decision and reinforces the regulatory appetite for neurologic rare-disease therapies with clear clinical differentiation. For Zevra, the decision creates additional work on evidence generation or label strategy ahead of future European submissions. The development matters to biotech operators because CHMP opinions can rapidly change how partners, payers, and market access teams plan for launch readiness. It also shows how the same product can face sharply different regulatory outcomes across geographies, pushing developers to align on end-point strategy and benefit-risk arguments tailored for each regulator.