Omeros reports Q2 2026 results as YARTEMLEA sales climb and CHMP issues negative opinion

Omeros Corporation reported financial results for the second quarter ended June 30, 2026, alongside a series of pipeline and regulatory updates. In Europe, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a negative opinion in June on Omeros' marketing authorization application for narsoplimab in TA-TMA.¹ The company said it believes the clinical evidence supports approval and has requested re-examination, under which an Ad Hoc Expert Group of external scientific and clinical experts in hematology and stem cell transplantation is expected to review the evidence and address questions central to CHMP's assessment.¹ Omeros continues to make YARTEMLEA available in Europe through an expanded access program, prioritizing children with TA-TMA.¹

On the U.S. commercial side, a permanent J-code for YARTEMLEA took effect July 1, and CMS granted the drug New Technology Add-on Payment status effective October 1, 2026, intended to support hospital reimbursement and patient access.¹ The company is also weighing expansion into other conditions involving endothelial injury or thrombo-inflammation, and expects enrollment to begin by year-end 2026 in two investigator-sponsored studies, one in hyperinflammatory ARDS and another testing prophylactic use in pediatric patients with predictably severe TA-TMA.¹

Elsewhere in the pipeline, Omeros is running a nonclinical study requested by the FDA before starting an inpatient trial of OMS527 for cocaine use disorder, and expects to begin enrollment in that trial by year-end 2026.¹ For its oncology program, a first-in-human Phase 1b trial of OMS805 in acute myeloid leukemia is targeted to begin in late 2027.¹

Financially, YARTEMLEA generated gross revenues of $32.2 million in the second quarter, up 190% from $11.1 million in the first quarter, with net revenue of $28.5 million.¹ The company held $132.0 million in cash and short-term investments as of June 30, 2026.¹ In July, Omeros repurchased $30.5 million of its 2029 convertible notes, cutting outstanding principal to about $40.3 million and reducing potential dilution shares from 11.4 million to 6.5 million.¹