Omeros: CHMP Issues Negative Opinion On Marketing Authorization Application For Narsoplimab

(RTTNews) - Omeros (OMER) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion on the marketing authorization application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy following re-examination of its original negative opinion adopted in June 2026. Omeros has informed CHMP of its intention to terminate the YARTEMLEA compassionate-use program.

Narsoplimab was approved under the brand name YARTEMLEA by the FDA in December 2025. Omeros said it is commercializing YARTEMLEA with its own field force in the U.S. market and plans to license commercialization rights to a third party in the European Union if EU marketing authorization is granted.

In pre-market trading on NasdaqGM, Omeros shares are down 8.14 percent to $17.26.

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