Omeros Launches Yarcomlia at $36,000 per Dose, Secures Supply Through 2029
Omeros will launch FDA-approved Yarcomlia in the U.S. beginning January with pricing set at $36,000 per single-dose vial, targeting 80 of 175 transplant centers that conduct 80% of procedures and secured supply through late 2029. Pivotal and expanded trials showed 61% complete response and 73% 100-day survival.
1. FDA Approval and Indication Scope
On December 23, 2025, the FDA granted approval for Yarcomlia (narsoplimab) as the first and only therapy for hematopoietic stem cell transplant–associated thrombotic microangiopathy (TATMA). The label covers adult and pediatric patients aged two and older, including both standard- and high-risk populations. Approval was based on a 28-patient single-arm pivotal trial supported by a 221-patient expanded access program, marking Omeros’ second FDA-approved product after Omidria.
2. Clinical Data Highlights
In the pivotal trial, 17 of 28 patients (61%) achieved “TMA Complete Response,” defined by improvement in laboratory markers and either organ function or transfusion independence. In the expanded access program, 13 of 19 evaluable patients (68%) reached complete response. Across both cohorts, 100-day survival from TMA diagnosis was 73% in the pivotal trial and 74% in the expanded access program. The approved label carries no boxed warning, no REMS requirement and no vaccination requirement, distinguishing it from off-label C5 inhibitors linked to higher infection-related mortality in published Emory University and Memorial Sloan Kettering cohorts.
3. U.S. Launch Execution, Pricing and Supply
Commercial launch began January 2 with a fully staffed team engaging 80 of the top 175 transplant centers, which account for approximately 80% of allogeneic procedures. Omeros has completed manufacturing campaigns and holds inventory with a five-year shelf life, sufficient to meet projected demand into late 2029. Packaging is underway, with transfers to the wholesaler targeted for mid-January and next-day delivery. The company set an initial per-vial price of approximately $36,000, with median utilization of 8 to 10 vials per treatment course.
4. Reimbursement Strategy and Pipeline Outlook
Pre-launch preparations secured a national ICD-10 code for TATMA and two CPT codes for Yarcomlia administration, with a HCPCS Level II J code pending. Omeros applied for a new technology add-on payment for inpatient Medicare, expected to take effect in October 2026 for three years. European marketing authorization is under review with a decision due mid-year, and global partnerships are being evaluated. Post-marketing commitments include a 50-patient safety registry due in 2034 and pediatric PK/PD data collection due in 2033. Omeros ended 2025 with about $172 million in cash and short-term investments and plans to advance OMS 1029, a phase-two–ready long-acting MASP-2 inhibitor, along with a small-molecule MASP-2 program.