ZNTL - Earnings announcements

Results from DENALI Part 1b show an Objective Response Rate (ORR) of ~35% in response-evaluable, heavily-pretreated patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC) Across monotherapy cohorts in key clinical studies, well-characterized safety and tolerability profile shows no new safety signals Company aligned with FDA on seamless study design for DENALI Part 2 in patients with Cyclin E1+ PROC; study expected to begin 1H 2025 Topline data from registration-intent DENALI Part 2 anticipated by year end 2026 Management to host conference call today at 8:00 am ET SAN DIEGO, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (

FDA has placed a partial clinical hold on ZN-c3-001, DENALI and TETON monotherapy studies of azenosertib Monotherapy data to be presented in the second half of 2024 Conference call to be held today, June 18, 8:00 am ET SAN DIEGO, June 18, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the following studies of azenosertib: the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the

 ORR of 36.8% in heavily pretreated platinum-resistant ovarian cancer and USC patients treated with intermittent dosing Establishes monotherapy RP2D of 400 mg QD with 5:2 dosing schedule; New RP2D more than doubles exposure levels, maintains safety and improves tolerability with no treatment-related discontinuations Company plans to update efficacy data from Phase 1 monotherapy dose optimization study and provide program timeline updates for three azenosertib Phase 2 monotherapy trials currently enrolling patients at the RP2D in the second half of 2023 Investor call at 8:00 a.m. ET today to review azenosertib monotherapy data supporting dose selection and chemotherapy combination da