EU regulators issue another negative opinion on MaaT Pharma's graft complication drug

European regulators have issued another negative assessment of Xervyteg, the flagship therapy of Lyon’s MaaT Pharma intended for severe intestinal graft-versus-host disease following organ transplantation. This latest "negative trend" follows an adverse opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in June, with a formal ruling slated for Friday. The agency argued that data from a 67-patient single-arm study fail to convincingly prove safety or efficacy, noting the absence of a randomized control group and the concurrent use of other treatments.

MaaT Pharma’s chief executive Hervé Affagard expressed deep disappointment and pledged to examine every possible route to bring the experimental drug to patients globally. The setback has already driven the company’s share price down roughly 60% after the first CHMP signal in May, and the firm had previously indicated it had financial runway only until November 2026.