Omeros announces FDA accepts BLA resubmission for narsoplimab in TA-TMA; PDUFA late Sept 2025

OMEROS CORP

FDA accepted Class 2 resubmission of BLA for narsoplimab for TA-TMA; PDUFA target action date late September 2025.
Resubmission includes survival analyses comparing narsoplimab-treated patients to external control, showing statistically significant improvement.
Also includes data from expanded access program in adult and pediatric TA-TMA patients.
Omeros is preparing MAA for submission to European Medicines Agency later this quarter.
Company responding to FDA information requests; expects interactive review.

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