Cogent Biosciences Highlights 2026 Milestones For Bezuclastinib And Precision Therapies Portfolio
Benzinga Newsdesk 10 months ago
BiotechNewsGeneral
New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026 NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new
- New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026
- NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 years
- Clinical data presentations from all three pivotal trials, PEAK, SUMMIT and APEX, expected at major medical meetings in 1H 2026
- Investigational New Drug (IND) applications expected in 2026 for potentially best-in-class pan-KRAS(ON) and selective JAK2 V617F inhibitors
- Strong financial position with ~$900 million cash to begin 2026, sufficient to fund commercial launches and operations well into 2028
- Company to present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 8:15 am PT/11:15 am ET