Omeros Gets FDA Approval of Yartemlea

By Colin Kellaher


Omeros has won U.S. Food and Drug Administration approval of its Yartemlea treatment for an often-fatal complication of stem-cell transplants.

Omeros on Wednesday said the approval covers Yartemlea for patients ages 2 and older with hematopoietic stem-cell transplant-associated thrombotic microangiopathy, a complication driven by the activation of the lectin pathway of complement.

The Seattle biopharmaceutical company said Yartemlea selectively inhibits the effector enzyme of the lectin pathway, blocking pathway activation while preserving classical and alternative complement functions important for host defense.

Omeros said the FDA green light makes Yartemlea the first and only approved lectin pathway inhibitor, adding that it is finalizing preparations for its U.S. product launch next month.

Trading in shares of Omeros, which closed Tuesday at $8.75, was halted premarket on Wednesday.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

December 24, 2025 09:27 ET (14:27 GMT)

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