secwatch.observer — SEC 8-K summary
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Issuer:     Cogent Biosciences, Inc. (COGT)
CIK:        0001622229
Form:       8-K
Filed at:   2024-06-27T23:59:59+00:00
Accession:  0001193125-24-169756
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cogent reaches FDA alignment on MS2D2 endpoint for SUMMIT trial; enrollment timeline reaffirmed
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- FDA alignment on novel patient-reported outcome measure MS2D2 for Part 2 of SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM).
- SUMMIT Part 2 enrollment on track to complete Q2 2025; top-line results expected by end of 2025.
- APEX study (Advanced SM) enrollment to complete end of 2024; top-line results mid-2025.
- PEAK study (GIST) enrollment expected to complete Q3 2024; top-line results by end of 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1622229/000119312524169756/0001193125-24-169756-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1622229/000119312524169756/d792910d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-169756

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