EMA CHMP upholds negative opinion on Omeros’ narsoplimab, EU compassionate‑use program to end
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reaffirmed its negative opinion on Omeros Corporation’s marketing authorization application for narsoplimab (YARTEMLEA) for TA‑TMA. Omeros said it will terminate its European compassionate‑use programme for the drug, citing rising U.S. commercial demand. The company’s shares fell sharply in pre‑market trading following the decision.
Why it matters
The negative CHMP opinion removes the prospect of EU market approval, limiting Omeros’ revenue potential outside the United States. The share price dropped 8.14% to $17.26 in pre‑market trading, reflecting investor concern over the lost European opportunity.
Key facts
- 1The CHMP maintained a negative opinion on the marketing authorization application for narsoplimab for TA‑TMA. tradingview.com
- 2Omeros will terminate its European compassionate‑use programme for YARTEMLEA, citing increasing U.S. commercial demand. tradingview.com
- 3Shares fell 8.14% to $17.26 in pre‑market trading after the CHMP decision. rttnews.com
- 4Narsoplimab was approved by the U.S. FDA in December 2025 under the brand name YARTEMLEA. tradingview.com
- 5Omeros plans to license EU commercialization rights to a third party if EU marketing authorization is granted. tradingview.com
Summary written by AlphAI AI Desk from 12 of 12 sources. Not investment advice. Figures are as stated by the linked sources.