secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2024-12-09T23:59:59+00:00
Accession:  0001193125-24-273393
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent Biosciences reports positive Phase 2 bezuclastinib data in AdvSM and NonAdvSM at ASH 2024
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- APEX (AdvSM): 52% ORR per mIWG-MRT-ECNM; 61% in TKI-naïve; 83% at 100 mg BID. Median PFS not reached; 24-mo PFS rate 82%.
- 100% PPR ORR at 100 mg BID; 94% of patients had >=50% tryptase reduction; 93% had >=50% KIT D816V VAF reduction.
- SUMMIT (NonAdvSM): 56% mean TSS improvement; 76% of patients had >50% MS2D2 reduction; 49% mean MC-QoL improvement at 24 wks.
- 95% of patients with baseline tryptase >=20 ng/mL achieved <20 ng/mL by week 24; 84% with baseline >11.4 ng/mL achieved <11.4.
- SUMMIT Part 2 enrollment complete (179 patients); top-line expected July 2025. APEX Part 2 enrollment completion Q1 2025; top-line mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312524273393/0001193125-24-273393-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312524273393/d914555d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-273393

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer