Omeros Achieves Commercial Milestone with First Approved Drug Launch

Omeros Corporation has initiated the commercial rollout of its inaugural FDA-approved therapy, YARTEMLEA®, in the United States. Following regulatory clearance in late December, the company recorded its first revenue from the drug at the end of January, marking a pivotal transition into a commercial-stage entity. YARTEMLEA® treats the rare complication transplant-associated thrombotic microangiopathy (TA-TMA), positioning Omeros as the sole provider of an approved therapeutic in this niche.

Concurrent with this product launch, Omeros has significantly bolstered its financial standing through a major licensing agreement. The company finalized a deal with Novo Nordisk for its investigational drug candidate, Zaltenibart, which includes an upfront payment of $240 million and near-term milestone payments totaling $100 million. The potential total value of the agreement could reach up to $2.1 billion.

Company leadership expressed confidence that these proceeds are sufficient to retire existing debt and fund operations for over twelve months. A key strategic objective is for the company to achieve positive cash flow by 2027.

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U.S. Launch Progress and European Prospects

The U.S. commercial introduction is proceeding according to plan. Since receiving FDA approval on December 24, multiple transplantation centers have placed orders, and patient administration of YARTEMLEA® is already underway. Omeros is also targeting international expansion, with a marketing authorization decision from the European Medicines Agency (EMA) anticipated around mid-year.

Upcoming Catalysts and Clinical Pipeline

Investor attention is now turning to the period between March 3 and April 2, when Omeros is scheduled to release its fourth-quarter and full-year 2025 financial results. This report will provide the first detailed insights into the early sales trajectory of YARTEMLEA® and the accounting treatment of the Novo Nordisk transaction.

Beyond this immediate milestone, Omeros continues to advance its broader clinical portfolio. The drug candidate OMS1029 has successfully completed its first phase of clinical studies. Furthermore, the company plans to initiate a clinical program for the treatment of acute myeloid leukemia (AML) in 2027.