secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2025-12-08T23:59:59+00:00
Accession:  0001193125-25-311217
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent reports positive SUMMIT and APEX trial results for bezuclastinib in mastocytosis
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312525311217/0001193125-25-311217-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312525311217/d81277d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-311217

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