EU Panel Upholds Negative Opinion on Omeros’ Narsoplimab Application

Bitget2026/10/16 10:20

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EMA's CHMP upheld its negative opinion on Omeros' narsoplimab marketing application following re-examination of its June 2026 decision.
The application covers hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), which has no approved therapy in Europe.
The FDA approved narsoplimab as Yartemlea in December 2025 for TA-TMA patients ages two and older.
Plans call for fully reimbursed named-patient access where permitted in Europe, rather than routine commercial access.
Rising US demand prompted plans to end compassionate use; current patients will receive enough drug to complete treatment.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Omeros Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20261016158704) on October 16, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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EU Panel Upholds Negative Opinion on Omeros’ Narsoplimab Application

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