Omeros Secures $240M Novo Nordisk Deal as Narsoplimab Approaches FDA Approval for TATMA
核心洞察
Omeros Corporation secured a $240 million upfront payment from Novo Nordisk for exclusive global rights to develop and commercialize altenobart (搜索), with an additional $100 million in near-term milestones achievable.
The company's MASP-2 (搜索) antibody narsoplimab (to be marketed as Yartemlia (搜索)) remains under FDA review for transplant-associated thrombotic microangiopathy (搜索) with a December 26, 2025 PDUFA date.
Recent publications in Blood Advances and American Journal of Hematology demonstrate significantly improved survival outcomes for TATMA (搜索) patients treated with narsoplimab compared to standard supportive care.
Omeros Corporation announced a transformative $240 million upfront licensing agreement with Novo Nordisk while positioning for the anticipated FDA approval of narsoplimab (Yartemlia (搜索)) for transplant-associated thrombotic microangiopathy (搜索) (TATMA (搜索)) by December 26, 2025.
Strategic Partnership with Novo Nordisk
The licensing deal grants Novo Nordisk exclusive global rights to develop and commercialize altenobart (搜索) and related antibodies targeting MASP-3 (搜索), with Omeros receiving $240 million upfront and access to an additional $100 million in achievable near-term milestones. The transaction provides Omeros with sufficient capital to fully repay its $67.1 million secured term loan, settle the remaining $17.1 million principal balance on 2026 convertible notes, and fund over twelve months of post-closing operations.
"This transaction represents a strategic and financial milestone for Omeros Corporation," said Gregory Demopulos, CEO. "It provides capital to advance our other high-value programs, including MASP-2 (搜索), oncology, TCAT, and PDE-7, while validating the depth of our science and development expertise."
Under the agreement, Omeros retains rights to continue development of its MASP-3 (搜索) small molecule inhibitor program with limited restrictions, while being broadly restricted from exploiting antibodies against MASP-3 and other specific alternative pathway targets in select high-priority indications for Novo Nordisk.
Narsoplimab Regulatory Progress and Commercial Readiness
The company's lead MASP-2 (搜索) antibody narsoplimab, which will be marketed as Yartemlia (搜索) upon approval, remains under FDA review with a Prescription Drug User Fee Act (PDUFA) date of December 26, 2025. In Europe, the marketing authorization application was validated by the European Medicines Agency (搜索) in June, with an anticipated decision in mid-2026.
Omeros has assembled a launch-ready commercial organization spanning leadership, market access, field teams, and market development liaisons. The company established a national ICD-10 diagnostic code for TATMA (搜索) and an associated CPT procedural code specific to Yartemlia (搜索), positioning the therapy as the only reimbursable TATMA treatment upon approval.
"Together, these position Yartemlia (搜索) once approved, as the only reimbursable TATMA (搜索) treatment," Demopulos noted. The company expects to receive Medicare's new technology add-on payment (NTAP) to support hospital reimbursement, with CMS scheduled to hold a town hall in December where Omeros will present supporting data.
Clinical Evidence Supporting Survival Benefits
Recent peer-reviewed publications have strengthened Yartemlia (搜索)'s clinical profile. A study published in Blood Advances, the Journal of the American Society of Hematology, demonstrated significantly improved survival in TATMA (搜索) patients treated with Yartemlia compared to a well-matched external control group receiving standard supportive care, analyzing data from both the pivotal clinical trial and global expanded access program.
A second publication in the American Journal of Hematology reported strong survival outcomes in patients treated under expanded access with Yartemlia (搜索) used as both first-line and salvage therapy in those who failed prior regimens with other complement agents including C5 (搜索) inhibitors and defibrotide. Importantly, no safety concerns were identified, consistent with all prior Yartemlia studies.
Safety Advantages Over C5 Inhibitors
A third study published in the American Journal of Hematology highlighted safety concerns with off-label C5 (搜索) inhibitor use. The Emory University study examining eculizumab in pediatric TATMA (搜索) reported an eight-and-a-half-fold increase in bacteremia and approximately six-fold increase in infection-related mortality compared with controls.
"This likely reflects the mechanism of C5 (搜索) inhibition, which impairs host defense. In contrast, MASP-2 (搜索) inhibition by Yartemlia (搜索) preserves immune protection," Demopulos explained.
Expanded Pipeline Development
Beyond Yartemlia (搜索), Omeros is advancing its MASP-2 (搜索) franchise including OMS 1029, a long-acting MASP-2 antibody designed for chronic diseases with dosing as infrequent as once quarterly. OMS 1029 is phase-two ready with both active drug and placebo manufactured and released.
The company's PDE7 (搜索) inhibitor program evaluating OMS 527 for cocaine use disorder (搜索) continues under a fully funded National Institute on Drug Abuse grant, with clinical trials expected to begin in 2026 following completion of animal interaction studies showing no drug interaction or safety issues.
Omeros is also developing its targeted complement activating therapy (TCAT) platform, designed for broad action against bacteria, fungi, viruses, and parasites. The novel approach harnesses complement activation to kill pathogens directly, with particular potential against multidrug-resistant organisms without contributing to drug resistance.
Oncology Platform Advancement
The company's Oncotox biologics program is advancing rapidly with acute myeloid leukemia (搜索) as the lead indication. The Oncotox AML (搜索) therapeutic has demonstrated superior efficacy to current standard of care treatments in human tumor-bearing mice and human AML cell lines, showing broad activity across AML genotypes including TP53, NPM1, KMT2A, and FLT3 mutations. A nonhuman primate safety study is underway with encouraging results, keeping the program on track for clinical entry in 2027.
Financial Position and Outlook
For the third quarter 2025, Omeros reported a net loss of $30.9 million or $0.47 per share, compared to $25.4 million or $0.43 per share in the second quarter. Excluding non-cash charges of $8.8 million associated with debt-related embedded derivatives, the adjusted net loss was $22.1 million.
The company held $36.1 million in cash and investments as of September 30, 2025, supplemented by $20.3 million in net proceeds from a July registered direct offering and $9 million from its at-the-market program during the quarter.
Following the Novo Nordisk transaction closure expected in Q4 2025 and anticipated Yartemlia (搜索) approval, Omeros expects to potentially achieve cash flow positivity in 2027, supported by the substantial upfront payment and commercial launch preparations.