Azenosertib (ZN-c3) (oral inhibitor of WEE1) mono

Development notes

DENALI (ZN-c3-005): 1/29/25- Reported topline data from Part 1b. 3/15/25- Presented updated data at (SGO) 2025. 4/28/25- First patient dosed in Part 2 with topline data by YE 2026. 11/10/25:- Enrollment in DENALI Part 2a is ongoing, with two intermittent dosing regimens; Part 2b will enroll approximately 70 patients at a single selected dose, and topline Part 2 data are expected by YE 2026 with the potential to support an accelerated approval, subject to FDA review. 01/06/26:- Completed DENALI Part 2a enrollment; dose confirmation and ASPENOVA Ph3 initiation expected H1 2026; topline Part 2 data YE 2026. 03/26/26:- FDA-aligned ASPENOVA Ph3 design; DENALI dose confirmation and topline Part 2 data remain expected H1 and YE 2026. 04/09/26:- DENALI chose 400mg QD 5:2. Part 2c and ASPENOVA start Q2 2026; topline YE 2026. 04/21/26:- FDA Fast Track for Cyclin E1+ PROC; CD validation ongoing in DENALI/ASPENOVA. 05/05/26:- ASPENOVA Ph3 first patient dosed; trial enrolling. DENALI Part 2 topline readout expected Year-End 2026. 05/12/26:- DENALI Part 2 selected 400mg QD 5:2 pivotal dose; interim analysis showed better responses and safety; topline YE 2026. 07/17/26:- ESMO 2026 will present DENALI Part 1b overall survival Oct 23, 2026; ASPENOVA trial-in-progress Oct 26. 08/06/26:- DENALI FDA aligned; ESMO OS update upcoming; Part 2 topline now H1 2027.