Omeros Shares Rally on Positive Survival Data for Narsoplimab
Investing.com -- Omeros Corporation shares surged 73% early Thursday following the release of positive survival data from an independent statistical analysis regarding the treatment of patients with thrombotic microangiopathy associated with hematopoietic stem cell transplantation (TA-TMA) using narsoplimab. The analysis demonstrated a more than threefold significant reduction in the risk of death for patients treated with narsoplimab compared to the control group.
The pivotal study, OMS721-TMA-001, compared the overall survival of 28 TA-TMA patients treated with narsoplimab to more than 100 high-risk TA-TMA patients from an external control registry who did not receive the treatment. The results revealed a hazard ratio of 0.32, indicating a 68% lower risk of death for the group treated with narsoplimab, with a p-value of less than 0.00001, deemed statistically significant.
Omeros is now preparing to resubmit its Biologics License Application (BLA) for narsoplimab to the FDA, aiming to become the first approved treatment for TA-TMA. TA-TMA is a life-threatening complication of stem cell transplantation. The company received recommendations from the FDA regarding the statistical analysis plan last month and, following the positive outcome, plans to submit the related European marketing authorization application in the second quarter of 2025.
The analysis was conducted by an independent external statistical group and agreed upon with the FDA. Adjustments were made for immortal time bias, considering demographic characteristics, diagnostic criteria, baseline characteristics, underlying diseases, conditioning regimens, and transplant procedures. The death risk profiles of the two cohorts were assessed as similar by an international expert panel.
Dr. Alessandro Rambaldi, a Hematology Professor at the University of Milan, emphasized the impressive benefits of narsoplimab in high-risk patients, noting a significant need for approved therapies in this area. Additional analyses, including the comparison of survival data from the global narsoplimab expanded access program with the registry, are ongoing and are expected to support the primary analysis.
Narsoplimab, which targets the effector enzyme MASP-2 in the lectin pathway, has been well-tolerated in various clinical trials, with no safety concerns arising. The results from the primary analysis have encouraged Omeros to expedite the process of making narsoplimab widely available to patients and physicians, with articles planned for peer-reviewed publication next year.
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