secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2022-12-12T23:59:59+00:00
Accession:  0001193125-22-302302
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent Biosciences reports 89% ORR in TKI-naive AdvSM patients from Phase 2 APEX trial
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- 89% ORR in TKI-naïve patients; 73% ORR in all evaluable patients (median 27-week follow-up).
- First confirmed CR at 20 weeks; 77% with ≥2 cycles had complete clearance of bone marrow mast cell aggregates.
- No related cognitive effects or intracranial bleeding; favorable safety profile with mostly Grade 1/2 events.
- Median age 69 years; subtypes: ASM (3), SM-AHN (12), MCL (1); 3 had prior avapritinib/midostaurin.
- Plans to present initial PEAK lead-in data H1 2023 and SUMMIT data H2 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312522302302/0001193125-22-302302-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312522302302/d421322d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-302302

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