Market Flux Event
Omeros Stock Falls After EU Regulators Uphold Second Rejection of Narsoplimab for Transplant Complication
Read this in the Market Flux appOmeros Corporation shares fell sharply on Friday after the European Medicines Agency's Committee for Medicinal Products for Human Use confirmed a negative opinion on the company's marketing authorization application for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, known as TA-TMA. The decision came after a full re-examination of the CHMP's original negative opinion, which was first issued in June 2026, and an eight-member ad hoc expert group was convened as part of that review process.
The upheld rejection marks a second consecutive setback for narsoplimab in Europe and closes off the regulatory pathway there for now. The announcement also coincided with the end of the company's compassionate-use program for the drug, removing an additional avenue through which European patients could access the treatment. OMER shares fell below a key technical support level for the first time in nearly three months following the news.
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Sources
- Business WireOmeros Corporation Receives CHMP Negative Opinion Following Re-Examination of European Marketing Authorization Application for Narsoplimab in TA-TMA
- BenzingaOmeros Stock Sinks on Negative EU Opinion for Narsoplimab, Compassionate-Use Program Ends
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- OpenOutcrier$OMER (-4.2% pre) Omeros shares slide following European regulatory setback for Narsoplimab