Azenosertib (ZN-c3) + ZEJULA (Niraparib) - (DENALI)

August 6, 2026: Zentalis Pharmaceuticals (NASDAQ: ZNTL) said FDA discussions left its accelerated approval strategy for azenosertib intact in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). In a Type D meeting, FDA had no objection to continuing the selected monotherapy dose of 400 mg once daily on a 5-days-on, 2-days-off schedule, and said the DENALI Part 2 population, including cohort 2c, could potentially support accelerated approval depending on data strength and the treatment landscape at review.

For DENALI Phase 2, enrollment is complete in Parts 2a and 2b, while Part 2c is enrolling. The integrated DENALI 2a/2b/2c dataset is intended to support accelerated approval, with topline data expected in 1H 2027. Earlier Part 2a selected the 400 mg dose; 300 mg recruitment was discontinued.

For ASPENOVA Phase 3, the first patient was dosed in May 2026; the confirmatory trial is enrolling and is intended to support full U.S. approval and approvals in major ex-U.S. markets.

Conference catalysts: ESMO 2026 accepted a rapid oral presentation on overall survival from DENALI Part 1b and a trial-in-progress poster on ASPENOVA design. At ASCO 2026, Phase 1b MUIR Part 1 data in azenosertib plus paclitaxel in PROC showed combinability and activity; MUIR Part 2 enrollment is ongoing for azenosertib plus bevacizumab in second-line platinum-sensitive ovarian cancer.

Cash, cash equivalents, and marketable securities were $174.6 million as of June 30, 2026, with runway into late 2027.