Zentalis initiates ASPENOVA Phase 3 trial of azenosertib in Cyclin E1-positive PROC

• Zentalis Pharmaceuticals advanced late-stage development of WEE1 inhibitor azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer, selecting 400 mg once daily on a 5-days-on, 2-days-off schedule as pivotal monotherapy dose based on an interim analysis from DENALI Part 2a.
• Interim findings supported a favorable benefit-risk profile, with fewer treatment discontinuations versus earlier study experience and no treatment-related deaths; no technical efficacy metrics were disclosed.
• DENALI Phase 2 topline results have not been presented; readout expected by year-end 2026, positioned as potential basis for accelerated approval depending on outcomes and FDA feedback.
• ASPENOVA Phase 3 confirmatory trial has started with first patient dosed in May 2026, designed to support conversion to full approval and ex-US filings.
• Cash, cash equivalents, marketable securities totaled $211.8 million as of March 31, 2026, with runway expected into late 2027 to fund planned milestones.

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