OMEROS CORP 8-K

What Happened Omeros Corporation (OMER) announced on December 24, 2025, that the U.S. Food and Drug Administration has approved YARTEMLEA® (narsoplimab‑wuug) for the treatment of hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA). The company filed a Current Report on Form 8‑K attaching a revised press release (Exhibit 99.1) dated December 24, 2025; the revision updated the approval‑related conference call date and added supplemental information about quoted experts.

Key Details

• FDA approval date announced: December 24, 2025.
• Approved product: YARTEMLEA® (narsoplimab‑wuug).
• Indication: hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA).
• Filing: Press release attached as Exhibit 99.1 to the Form 8‑K; press release was revised only to reflect a new conference call date and to add information about experts quoted.

Why It Matters This FDA approval is a material regulatory milestone for Omeros because it permits the company to market YARTEMLEA in the U.S. for TA‑TMA, a serious complication of stem‑cell transplantation. The Form 8‑K does not include financial results, sales projections, or commercialization details, so investors should watch for subsequent company disclosures (e.g., launch plans, pricing, and guidance) that would address potential revenue impact.