FDA Accepts Bezuclastinib NDA for NonAdvanced Mastocytosis, Sets PDUFA Date Dec. 30 2026
FDA accepted Cogent’s NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis and set a December 30, 2026 PDUFA target date with no advisory committee or review issues flagged. The SUMMIT trial reported statistically significant improvements across primary and key secondary endpoints through 48 weeks, showing deepening symptom improvements and favorable safety.
1. FDA Acceptance of NDA
The FDA has accepted Cogent’s NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis and assigned a PDUFA target date of December 30, 2026. The agency indicated it will not convene an advisory committee and has identified no review issues at this time.
2. SUMMIT Trial Outcomes
The pivotal SUMMIT trial data through 48 weeks showed statistically significant improvements across primary and key secondary endpoints, including symptom relief and sustained deepening of response over time. The study also reported favorable safety and tolerability, bone mineral density benefits, and evidence of disease modification in patients with high unmet needs.
3. Upcoming Submissions
Cogent plans to complete its NDA submission for bezuclastinib in GIST patients previously treated with imatinib by April 2026 under Real-Time Oncology Review and intends to file the AdvSM NDA during the first half of 2026. The GIST program has Breakthrough Therapy Designation in place for expedited review.