secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001193125-25-273315
Event type: other_material
Sentiment:  positive
Materiality: 0.95
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent: bezuclastinib combo reduces progression risk by 50% in Phase 3 GIST trial
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- PEAK trial met primary endpoint: HR 0.50 (95% CI: 0.39–0.65) for progression-free survival.
- Median PFS 16.5 months (bezuclastinib + sunitinib) vs 9.2 months (sunitinib alone).
- Objective response rate 46% (combo) vs 26% (sunitinib), safety generally manageable.
- Company plans NDA submission for NonAdvSM by end 2025; GIST NDA in H1 2026.
- Top-line APEX AdvSM trial results expected December 2025; ASH presentations upcoming.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/0001193125-25-273315-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/d54064d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-273315

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