Cogent Biosciences Reports $901M Cash Runway and Three Bezuclastinib NDA Filings
Cogent Biosciences enters 2026 with three bezuclastinib NDAs underway, including a December 2025 filing for NonAdvSM and an RTOR-enabled GIST submission, with an Advanced SM application due in H1 2026. The company reported $901 million cash runway into 2028 and Phase 3 PEAK trial showing 16.5-month versus 9.2-month progression-free survival.
1. Regulatory Milestones for Bezuclastinib
Cogent has submitted a December 2025 NDA for bezuclastinib in NonAdvanced SM, initiated the PEAK NDA under the FDA’s RTOR program for second-line GIST and plans an APEX NDA submission for Advanced SM in the first half of 2026 after receiving Breakthrough Therapy Designation.
2. Phase 3 PEAK Trial Outcomes
The Phase 3 PEAK trial demonstrated a median progression-free survival of 16.5 months for bezuclastinib plus sunitinib versus 9.2 months for sunitinib alone, with a 46% objective response rate compared to 26% and no new safety concerns.
3. Strong Financial Position
Cogent ended 2025 with $901 million in cash and equivalents, bolstered by $546.8 million net proceeds from November public offerings, providing funding into 2028 and supporting planned commercial build-out for bezuclastinib.
4. Pipeline and Upcoming Milestones
Beyond bezuclastinib, Cogent advances several candidates, including the JAK2 V617F inhibitor CGT1145 and KRAS inhibitor CGT1263, with multiple IND submissions and clinical data presentations slated throughout 2026.