Omeros Announces FDA Approval of YARTEMLEA and Conference Call on January 7, 2026

H.C. Wainwright reiterated a Buy rating and $20 price target on Omeros following the FDA approval of Yartemlea for hematopoietic stem cell transplant-associated thrombotic microangiopathy. The firm sees the Yartemlea approval as a "significant validation" of Omeros value. H.C. Wainwright's current model assumed an 80% probability of success for Yartemlea in the U.S., and pricing of $150K per patient.

H.C. Wainwright analyst Brandon Folkes keeps a Buy rating on Omeros with a $9 price target after the company submitted its marketing authorization to the European Medicines Agency for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The announcement supports H.C. Wainwright's view that Omeros shares "may be entering a phase of rerating" over the next 12 months, driven by a potential U.S. approval for narsoplimab, EU approval, and subsequent re-appreciation of the potential in the company's other pipeline programs, the analyst tells investors in a research note. The firm believes the European submission adds another "significant catalyst" for the stock in 2026. H.C. Wainwright says narsoplimab will be approved in the U.S. and Europe, and will create significant value for Omeros.

"We are pleased to announce that our narsoplimab BLA for the treatment of TA-TMA was resubmitted to FDA earlier this month, with the MAA slated for European submission in the coming quarter," stated Gregory A. Demopulos, M.D., Chairman and CEO of Omeros. "All study results in the BLA are uniformly strong across all comparative analyses and all datasets - the primary and primary-related sensitivity analyses, the 136-patient expanded access program, adults and children, and patients who had failed treatment with other off-label agents prior to receiving narsoplimab. With a six-month review cycle from the date of resubmission, we look forward to working closely with FDA toward narsoplimab's approval and our commercial team is well-prepared to execute a successful market launch. Zaltenibart's compelling results in our Phase 2 PNH trials are highly predictive of the similarly designed and ongoing Phase 3 program in PNH, which remains on track to readout data late next year, and we are focused on establishing ex-U.S. partnerships for both zaltenibart and narsoplimab. Also later this year, we expect data from our NIDA-funded OMS527 trial in patients with cocaine use disorder. Collectively, these programs in BLA review and with near-term clinical trial results translate to significant shareholder value."