Omeros Corp

2 products tracked · names used in filings: Omeros Corp, Omeros Ireland Limited

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Thu 15 Oct 2026🇪🇺 CHMP negative opinion

Yartemlea (Narsoplimab): CHMP negative opinion

Omeros Ireland Limited · source

Fri 26 Dec 2025🇺🇸 PDUFA datecompany-announced

narsoplimab (YARTEMLEA): PDUFA target action date (hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA))

Omeros Corp (OMER); narsoplimab; BLA; status: extended; "Following a comprehensive response to an FDA information request, the Agency extended the PDUFA date to December 26, 2025."; filed 2025-11-13 · source

Tue 23 Dec 2025🇺🇸 FDA approval

FDA approves Yartemlea (narsoplimab-wuug), a new medicine

Omeros Corp; BLA761152; New biologic, Priority review; injection · source

Tue 06 May 2025🇺🇸 PDUFA datecompany-announced

Omeros Corp: PDUFA target action date

Omeros Corp (OMER); "FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date SEATTLE, WA – May 6, 2025 – Omeros Corporation (Nasdaq: OMER) today announced that the U.S."; filed 2025-05-06 · source

Products

	Product	Status	Approved
🇪🇺	Yartemlea Narsoplimab	Opinion
🇺🇸	Yartemlea narsoplimab-wuug	Approved	2025-12-23

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.