---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-155811"
form_type: "8-K"
ticker: "COGT"
cik: "0001622229"
company_name: "Cogent Biosciences, Inc."
filed_at: "2025-07-07T23:59:59+00:00"
generated_at: "2026-05-18T09:17:09.446371+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Cogent reports positive top-line results from SUMMIT trial of bezuclastinib in non-advanced systemic mastocytosis

## Summary
- SUMMIT Part 2 met primary endpoint with highly significant mean TSS reduction of 24.3 points vs placebo 15.4 (p=0.0002) at 24 weeks.
- 87.4% of bezuclastinib patients had ≥50% reduction in serum tryptase vs 0% on placebo (p<0.0001).
- All key secondary endpoints achieved statistical significance, including KIT D816V VAF and bone marrow MC aggregates reductions.
- Company on track to submit NDA to FDA for bezuclastinib in NonAdvSM by end of 2025; detailed results planned for medical meeting.
- Safety profile manageable: most TEAEs low grade, discontinuations due to ALT/AST elevations (5.9%) all resolved.

## SEC filing metadata
- accession: 0001193125-25-155811
- form_type: 8-K
- ticker: COGT
- cik: 0001622229
- company_name: Cogent Biosciences, Inc.
- filed_at: 2025-07-07T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1622229/000119312525155811/0001193125-25-155811-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1622229/000119312525155811/d156610d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-155811
- JSON: https://secwatch.observer/filing/0001193125-25-155811.json
- Plain text: https://secwatch.observer/filing/0001193125-25-155811.txt

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