secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2023-12-11T23:59:59+00:00
Accession:  0001193125-23-292084
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent reports positive Phase 2 bezuclastinib data in systemic mastocytosis at ASH 2023
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- SUMMIT Part 1a: 100% of bezuclastinib patients achieved ≥50% reduction in serum tryptase vs 0% on placebo; 100% achieved ≥50% reduction in KIT D816V VAF.
- APEX Part 1: 52% ORR per mIWG-MRT-ECNM criteria (56% in TKI-naïve); 75% PPR ORR (86% in TKI-naïve).
- Safety: no related cognitive impairment or bleeding events; most AEs low grade and reversible.
- SUMMIT Part 2 (registration-directed) to start H1 2024; APEX Part 2 (~65 patients) enrollment on track for end of 2024.
- 100% of bezuclastinib patients in SUMMIT with measurable baseline mast cell aggregates achieved ≥50% reduction in bone marrow mast cell burden vs 14% placebo.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312523292084/0001193125-23-292084-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312523292084/d844329d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-292084

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