other material
confidence high
sentiment positive
materiality 0.75
Clene reports CNM-Au8 survival benefit in ALS: median survival up 198 days vs control
Clene Inc.
- Median survival 951 days for CNM-Au8 30 mg vs 753 days for Regimen A comparator, a 198-day (6.5-month) gain.
- Covariate-adjusted RMST improvement of 124 days (p=0.045); sensitivity analyses including NfL and TRICALS confirm robustness.
- In moderate-to-severe ALS (NfL>33, TRICALS -6.5 to -2.5), median survival gain 11.9 months; mortality risk reduced 44% (p=0.006).
- RESTORE-ALS-eligible subset: median survival 1079 vs 628 days (451-day gain, 14.8 mo), mortality risk reduced 49% (p=0.006).
- Clene to discuss findings with FDA; Phase 3 RESTORE-ALS study launch targeted for mid-2025.