regulatory
confidence high
sentiment positive
materiality 0.65
Cogent reaches FDA alignment on MS2D2 endpoint for SUMMIT trial; enrollment timeline reaffirmed
Cogent Biosciences, Inc.
- 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.