Core Insights - Omeros Corporation announced the completion of the primary statistical analysis for narsoplimab, a monoclonal antibody targeting TA-TMA, in agreement with the FDA [1][4] - Narsoplimab demonstrated significant improvement in overall survival for TA-TMA patients compared to an external control group [3][2] - The company plans to resubmit the Biologics License Application (BLA) for narsoplimab for TA-TMA and aims for a European marketing authorization application submission in Q2 2025 [5] Company Developments - The independent statistical analysis compared 28 TA-TMA patients treated with narsoplimab in the OMS721-TMA-001 trial to over 100 high-risk TA-TMA patients who did not receive the treatment [2][4] - Narsoplimab achieved a hazard ratio of 0.32, indicating a clinically meaningful and statistically significant improvement in overall survival [3] - Narsoplimab has shown good tolerability and no safety concerns across all clinical trials conducted to date [5] Market Reaction - Following the announcement, Omeros' stock price increased by 54.8%, reaching $11.55 [7]
Omeros Antibody Improves Overall Survival In Rare Complication After Stem Cell Transplant, Stock Surges