Bezuclastinib has exhibited promising initial data across all three trials (APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST), including an encouraging safety profile across 600+ patients in single agent and combination dosing. The company submitted a New Drug Application (NDA) for NonAdvSM in December 2025, with NDA submissions for AdvSM on track for 1H 2026 and GIST on track for April 2026.
Cyborg Score Rationale
Cogent Biosciences soared 120% after positive Phase 3 PEAK study results for bezuclastinib in imatinib-resistant GIST patients. The company has multiple late-stage programs advancing with recent breakthrough therapy designation and strong clinical data supporting commercialization within 2026. However, as a pre-revenue biotech, execution risk remains material.
Top Insights
Bezuclastinib received Breakthrough Therapy Designation in combination with Sunitinib for certain indications in January 2026.
According to 13 analysts, the average rating for COGT stock is "Buy."
The company has 205 full-time employees as of the latest reporting period.
Three parallel NDA pathways (NonAdvSM, AdvSM, GIST) position company for potential multi-indication launches in 2026-2027.
Named Competitors
Blueprint Medicines — Precision medicine for genetically defined cancers
Kite Pharma — Cell therapy and oncology innovations
Ventyx Biosciences — Immunology and precision therapeutics
Recent Developments
(January 2026) Cogent announced Breakthrough Therapy Designation for Bezuclastinib in combination with Sunitinib
(January 2026) Announced 2026 milestones including anticipated NDA submissions for multiple indications
(December 2025) Submitted NDA to FDA for bezuclastinib in NonAdvanced Systemic Mastocytosis
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