other material
confidence high
sentiment positive
materiality 0.80
Cogent reports positive SUMMIT and APEX trial results for bezuclastinib in mastocytosis
Cogent Biosciences, Inc.
- SUMMIT Part 2: mean TSS change -24.3 (-43%) vs placebo -15.4 (-29%), p<0.001; 34.3% vs 18.1% had >=50% TSS reduction (p=0.01).
- SUMMIT: 87.4% had >=50% serum tryptase reduction; 75.6% had >=50% bone marrow mast cell reduction (p<0.001 vs placebo).
- APEX Part 2 top-line: 57% ORR (CR+CRh+PR+CI) per mIWG criteria; 80% ORR per pure pathological response.
- APEX: 89% had >=50% serum tryptase reduction; 91% had >=50% KIT D816V VAF reduction; no discontinuations due to TRAEs.
- Cogent expects to submit NDA for bezuclastinib in AdvSM to FDA in H1 2026; detailed APEX data at scientific meeting H1 2026.