Key Takeaway: Omeros Corporation announced that the CHMP of the EMA has issued a negative opinion regarding its marketing authorization application for narsoplimab, intended for treating TA-TMA. This decision comes after a re-evaluation of an earlier negative opinion from June 2026, affecting the company's prospects in the European market.
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CONCERNS & RISKS
CHMP issued a negative opinion on narsoplimab's marketing authorization application.
This follows a re-examination of a previously negative opinion from June 2026.
The decision impacts Omeros Corporation's plans for narsoplimab in Europe.
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Full Press Release Details
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the company’s marketing authorization application (MAA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) following re-examination of its original negative opinion adopted in June 2026. An eight-member ad hoc expert group (
Frequently Asked Questions
What is the CHMP's opinion on narsoplimab?
The CHMP issued a negative opinion on the marketing authorization application for narsoplimab.
What condition is narsoplimab intended to treat?
Narsoplimab is intended for treating thrombotic microangiopathy associated with stem cell transplants.
When was the original negative opinion issued?
The original negative opinion was adopted in June 2026.
How does this affect Omeros Corporation?
This decision impacts Omeros Corporation's plans for narsoplimab in the European market.