Omeros (OMER, Financials) announced progress toward resubmitting its biologics license application for narsoplimab, its antibody targeting MASP-2 for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy; Omeros shares are up 32.3% to $10.23 in Friday's morning trading, following the news.
The business acknowledged that it is getting ready the required data for submission and has responded to comments from the U.S. Food and Drug Administration on its updated statistical analysis plan.
Omeros said the FDA does not have any more presubmission information requirements, hence the business is not aware of any challenges to finish the resubmission process. An independent statistical group will handle the main endpoint and additional analyses after data preparation is complete. Should the findings support the application, the business intends to swiftly resubmit the BLA.
Feedback from the FDA during a September 2024 conference includes further sensitivity studies for the main effectiveness objective. Omeros changed the statistical plan in line, and the FDA has given further suggestions the business finds reasonable. Before doing the effectiveness studies, the independent statistical group will follow these advice.
Omeros plans to announce the main and any other results after finishing and verifying the analysis.
