---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-273315"
form_type: "8-K"
ticker: "COGT"
cik: "0001622229"
company_name: "Cogent Biosciences, Inc."
filed_at: "2025-11-10T23:59:59+00:00"
generated_at: "2026-05-16T22:24:58.386865+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Cogent: bezuclastinib combo reduces progression risk by 50% in Phase 3 GIST trial

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-273315
- form_type: 8-K
- ticker: COGT
- cik: 0001622229
- company_name: Cogent Biosciences, Inc.
- filed_at: 2025-11-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/0001193125-25-273315-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1622229/000119312525273315/d54064d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-273315
- JSON: https://secwatch.observer/filing/0001193125-25-273315.json
- Plain text: https://secwatch.observer/filing/0001193125-25-273315.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.