other material
confidence high
sentiment negative
materiality 0.85
Neumora's Phase 3 KOASTAL-1 study of navacaprant fails primary endpoint in MDD
Neumora Therapeutics, Inc.
- Primary endpoint MADRS total score change at Week 6: -12.5 for both navacaprant and placebo (p=0.993); no statistical improvement.
- Key secondary endpoint SHAPS also missed: -5.8 vs -5.5 (p=0.648).
- Pre-specified subgroup analysis showed efficacy signal in females: MADRS LSMD -2.7 (p=0.072); SHAPS LSMD -2.3 (p=0.015).
- Navacaprant generally well-tolerated; no serious adverse events; discontinuation 2.1% vs 3.1% for placebo.
- Cash balance $342M provides runway into mid-2026; J.P. Morgan Healthcare Conference update planned Jan 14.