Omeros (NASDAQ:OMER) outlined its U.S. launch plans for Yarcomlia (narsoplimab) and discussed clinical data, reimbursement preparations, and supply expectations following the drug’s FDA approval on December 23, 2025, during a company conference call led by Chairman and CEO Dr. Gregory Demopulos.
FDA approval and scope of the indication
Demopulos said Yarcomlia is the first and only therapy approved by the FDA or any regulatory authority for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA), which he described as a life-threatening transplant complication that can lead to severe chronic morbidity among survivors, including kidney failure requiring long-term dialysis.
Demopulos stated the Yarcomlia label includes all TATMA patients—both standard-risk and high-risk—and covers adult and pediatric patients age two and older. FDA approval was based on a 28-patient single-arm pivotal trial supported by a 221-patient expanded access program.
Clinical efficacy and safety profile discussed
Omeros highlighted efficacy using “TMA Complete Response,” which it defined as improvement in key laboratory markers (including platelet counts and LDH levels) together with either improved organ function or transfusion independence. Complete response was achieved in 17 of 28 patients (61%) in the pivotal trial and 13 of 19 evaluable patients (68%) in the expanded access program, according to Demopulos.
Across the pivotal study and the expanded access program, the company reported 100-day survival from time of TMA diagnosis of 73% and 74%, respectively, based on all-cause mortality. Demopulos noted that while the approved label includes all TATMA patients, all patients in these studies met international harmonization criteria for high-risk TATMA.
Demopulos also emphasized Yarcomlia’s “differentiated safety profile,” stating its approved label carries no boxed warning, no risk evaluation and mitigation strategy (REMS), and no vaccination requirement. He contrasted this with off-label use of other complement inhibitors in TATMA and cited two publications: an Emory University pediatric cohort in which use of the C5 inhibitor eculizumab was associated with increased infection risk and infection-related mortality, and a Memorial Sloan Kettering Cancer Center report in adults linking eculizumab to higher risk of death driven by non-relapse mortality with deaths predominantly due to infection.
Launch execution, pricing, and supply expectations
Demopulos said Omeros initiated the commercial launch on January 2, with a fully hired and trained commercial team contacting U.S. transplant centers to educate transplant physicians, nurses, hospital pharmacies, and reimbursement teams. The company is initially prioritizing 80 transplant centers (out of 175 in the U.S.), noting that the top 40 account for about 60% of procedures and the top 80 represent about 80%.
On supply, Demopulos said completed manufacturing campaigns, existing inventory, and a five-year shelf life are expected to provide sufficient drug supply to meet commercial demand into late 2029. Packaging was underway and Omeros was targeting transfer to its wholesaler in the third week of January, with next-day delivery intended under its distribution model.
Omeros set an initial per-vial price of approximately $36,000, with each vial representing a single dose. Demopulos said median utilization was 8 to 10 vials per treatment course across the pivotal trial and expanded access program. In the Q&A, management said it expects two to three doses may be administered inpatient before transitioning dosing to hospital outpatient departments (HOPDs), where it expects the majority of dosing to occur.
Reimbursement and coding strategy
Chief Commercial Officer Nadia Dac said reimbursement preparations began pre-launch and described progress on coding and access infrastructure. Omeros has established a national ICD-10 diagnostic code for TATMA and two product-specific CPT procedure codes for Yarcomlia (for peripheral and central venous administration). The company also said it has applied for a HCPCS Level II J code and expects to receive it to support clearer identification and more standardized reimbursement.
For inpatient Medicare reimbursement, Omeros applied for a new technology add-on payment (NTAP). Dac said the company expects NTAP to become effective in October 2026 and remain active over the subsequent three years, describing it as a way to provide additional payments to hospitals for high-cost innovative technologies until standard payment systems incorporate them.
Omeros said telephone support is already live via 1-844-YARCOM1 and its “Yarcomlia Assist” program is expected to be fully operational in early February.
Market size framing, Europe, and pipeline comments
Demopulos cited approximately 11,000 allogeneic transplants performed annually in the U.S. and 20,000 annually in Europe. He referenced recent studies estimating that TATMA develops in up to 56% of allogeneic transplant recipients, while also acknowledging underdiagnosis and the importance of time to diagnosis. In response to a question about prevalence, Demopulos pointed to the “MITIS” study as a recent, well-respected source for the 56% figure, and outside experts on the call said increased awareness and structured diagnostic criteria may lead to more screening and earlier diagnosis.
Omeros said its marketing authorization application is pending with the European Medicines Agency, with a decision expected mid-year. The company said it is evaluating potential global and regional partnerships for ex-U.S. commercialization.
On post-marketing obligations, Chief Regulatory Officer Dr. Kathy Melfi said the FDA required one post-marketing requirement: a registry of 50 adult and pediatric TATMA patients with one year of follow-up to assess major safety findings, due in 2034. She also described a post-marketing commitment to collect PK, PD, and safety data in pediatric TATMA patients treated with narsoplimab, due in 2033, along with five CMC-related post-marketing commitments, two of which she said were already completed and would be submitted to the FDA that month.
Demopulos said that with FDA approval validating MASP-2 inhibition and Yarcomlia now commercial, Omeros plans to expand indications and advance a long-acting MASP-2 inhibitor (OMS 1029), which he described as “phase two ready,” as well as a MASP-2 small molecule program. He also said the company ended 2025 with approximately $172 million of cash and short-term investments available for operations.
About Omeros (NASDAQ:OMER)
Omeros Corporation is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule and protein therapeutics. The company’s research programs target inflammation, complement-mediated diseases and disorders of the central nervous system. Omeros’s portfolio encompasses both internally discovered molecules and biologics, reflecting its commitment to advancing treatments for conditions with high unmet medical need.
Omeros’s first FDA-approved product, Omidria® (phenylephrine and ketorolac intraocular solution), is indicated to maintain pupil size by preventing intraoperative miosis and reducing postoperative pain in patients undergoing cataract surgery.
