other material
confidence high
sentiment positive
materiality 0.90
Omeros narsoplimab meets TA-TMA pivotal trial primary endpoint; HR 0.32 for survival
OMEROS CORP
- Narsoplimab-treated TA-TMA patients had over 3-fold reduction in risk of death (HR 0.32, 95% CI 0.23-0.44, p<0.00001) vs >100 external control patients.
- Omeros will resubmit the narsoplimab BLA to FDA as soon as possible for first approved TA-TMA therapy.
- Expanded access program data: 46% of adults and 50% of children achieved TA-TMA resolution after failing C5 inhibitors.
- European marketing authorisation application planned for Q2 2025; additional sensitivity analyses and manuscripts expected early 2025.