Cogent Biosciences Eyes H2 2026 Bezuclastinib Launch After FDA NDA Acceptance, Holds $900.8 M Cash
FDA accepted NDA for bezuclastinib in GIST following Breakthrough Therapy Designation, with launch slated for H2 2026 pending approval. Cogent ended 2025 with $900.8 M cash, repaid $54.8 M of debt, but widened net loss to $328.9 M as R&D spending rose to $269.8 M.
1. Regulatory Milestones
On February 17 the FDA accepted the New Drug Application for bezuclastinib in gastrointestinal stromal tumors after granting Breakthrough Therapy Designation, positioning the drug for a potential second-half 2026 launch pending final approval. Six abstracts from the SUMMIT trial in non-advanced systemic mastocytosis have been accepted for presentation at the 2026 AAAAI annual meeting.
2. Financial Position
Cogent closed 2025 with $900.8 M in cash equivalents and marketable securities and repaid $54.8 M of long-term debt in Q4. Research and development expenses climbed to $75.6 M in Q4 2025 and $269.8 M for the full year, contributing to a widened net loss of $102.5 M in Q4 and $328.9 M for the year compared to $67.9 M and $255.9 M in 2024.
3. Pipeline Focus
Bezuclastinib (CGT9486) is a potent, selective inhibitor targeting the KIT D816V mutation in systemic mastocytosis and advanced GIST, showing clear clinical benefits across symptom domains. As the company’s lead precision therapy, it anchors Cogent’s oncology pipeline and key value drivers.