other material
confidence high
sentiment negative
materiality 0.85
Omeros Phase 3 ARTEMIS-IGAN trial fails primary endpoint; narsoplimab BLA in IgAN discontinued
OMEROS CORP
- Narsoplimab did not achieve statistically significant reduction in proteinuria at 36 weeks vs placebo (24-hour UPE >2 g/day).
- Placebo group showed markedly greater proteinuria reduction than in other IgA nephropathy trials.
- Company will not submit BLA for narsoplimab in IgAN and is discontinuing the ARTEMIS-IGAN trial.
- Funds redirected to OMS906 (alternative pathway inhibitor) Phase 2/3 programs and narsoplimab BLA resubmission for HSCT-TMA.
- Narsoplimab was generally well tolerated with no new safety concerns.