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SEATTLE - Omeros Corporation (NASDAQ:OMER), a biotechnology company with a market capitalization of $194.5 million, has submitted a Marketing Authorization Application to the European Medicines Agency for narsoplimab, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), according to a press release statement. The company’s stock, currently trading at $3.32, has experienced significant volatility, having declined over 71% in the past six months.
The application includes data showing a 61% response rate in narsoplimab-treated patients and a three-fold improvement in overall survival compared to a matched external control group. The submission also contains outcomes from over 130 TA-TMA patients treated under the company’s expanded access program. According to InvestingPro analysis, Omeros operates with a significant debt burden of $415 million and is currently burning through cash rapidly, factors that investors should consider alongside the company’s clinical progress.
Narsoplimab has received orphan drug designation from the EMA for treatment in hematopoietic stem cell transplant, allowing review through the centralized procedure. This enables a single marketing authorization across EU member states and European Economic Area countries.
The review process will begin in mid-July following a standard timeline. The Committee for Medicinal Products for Human Use will conduct the scientific assessment, with a final European Commission decision expected in mid-2026.
In the United States, the Food and Drug Administration has accepted for review Omeros’ resubmitted Biologics License Application for narsoplimab with a target action date of September 25, 2025. Analyst price targets for Omeros range from $9 to $36, reflecting diverse opinions about the company’s potential. InvestingPro subscribers can access 8 additional key insights about Omeros’s financial health and market position through the comprehensive Pro Research Report.
TA-TMA is a potentially fatal complication of stem cell transplantation with no approved therapy or standard of care. The condition affects approximately 40% of allogeneic transplant recipients, with mortality exceeding 90% in severe cases.
Narsoplimab is a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, an enzyme in the lectin pathway of complement, which plays a role in the development of TA-TMA.
In other recent news, Omeros Corporation reported a net loss of $33.5 million for the first quarter of 2025, equating to a loss of $0.58 per share, which met analyst expectations. The company achieved a significant milestone by reducing its total debt by $10 million. Additionally, Omeros received $6.7 million in royalties from OMIDRIA during the quarter. The resubmission of narsoplimab’s Biologics License Application (BLA) to the FDA is a critical development, with potential approval anticipated by September 2025. This approval could position narsoplimab as the first treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA). Analysts from WBB Securities have shown interest in the company’s preparedness for the commercial launch of narsoplimab, highlighting the importance of patient access to this potential new therapy. Omeros is also working on securing additional capital to support its strategic initiatives and further product development. The company aims to continue its focus on product innovation and market expansion, despite ongoing financial challenges.
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