Earnings summaries and quarterly performance for Zentalis Pharmaceuticals.
Executive leadership at Zentalis Pharmaceuticals.
Board of directors at Zentalis Pharmaceuticals.
Research analysts covering Zentalis Pharmaceuticals.
Recent press releases and 8-K filings for ZNTL.
Zentalis Pharmaceuticals Details Azenosertib's Accelerated Approval Strategy and Clinical Progress
ZNTL
New Projects/Investments
Guidance Update
- Zentalis Pharmaceuticals' CEO, Julie Eastland, and CMO, Ingmar Bruns, who joined in Fall 2024, presented azenosertib as a first oral non-chemo treatment for biomarker-selected patients, demonstrating response rates over 30% and approximately 6 months duration of response.
- The company is advancing azenosertib towards accelerated approval through the DENALI trial, with Part 2 expected to read out by year-end (2026) for approximately 100 patients at the selected dose.
- A Phase 3 confirmatory ASPENOVA trial is also underway to support full approval, with FDA alignment on both trial designs for accelerated and full approval pathways.
- Management highlighted azenosertib's manageable safety profile and quality-of-life benefits as an oral treatment, differentiating it from IV chemotherapy and ADCs.
3 days ago
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Trials and Regulatory Pathway
ZNTL
New Projects/Investments
- Zentalis Pharmaceuticals is advancing azenosertib, an oral non-chemo treatment, through two key trials: the DENALI trial for potential accelerated approval and the ASPENOVA trial for full approval.
- The company expects to have data from approximately 100 patients in Part two of the DENALI trial by year-end 2026, which could serve as the basis for accelerated approval in PROTAC Cyclin E1-positive patients.
- Azenosertib has demonstrated meaningful benefit with response rates over 30% and approximately six months duration of response in this biomarker-selected population.
- Zentalis has received FDA alignment on the accelerated approval pathway for DENALI and the design of the confirmatory ASPENOVA Phase III study.
3 days ago
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Development and Regulatory Strategy
ZNTL
New Projects/Investments
Guidance Update
- Zentalis is developing azenosertib, an oral non-chemo treatment for PROTAC Cyclin E1-positive patients, which has demonstrated response rates over 30% and approximately 6 months duration of response.
- The company is pursuing accelerated approval for azenosertib through the ongoing DENALI trial, with results from about 100 patients expected by year-end.
- A confirmatory Phase 3 ASPENOVA trial is planned for full approval, and Zentalis has maintained consistent regulatory interactions with the FDA regarding both trial designs and the accelerated approval pathway.
- Azenosertib is positioned as a differentiated non-chemo oral option offering significant convenience and quality of life benefits for patients.
3 days ago
Zentalis Provides Updates on Azenosertib Clinical Development and Strategic Priorities
ZNTL
New Projects/Investments
Guidance Update
Product Launch
- Zentalis's primary strategy is to rapidly advance azenosertib for patients with platinum-resistant ovarian cancer (PROC) who have high Cyclin E1 expression.
- The company expects to provide dose selection guidance for the DENALI Part 2 trial in the first half of 2026 and anticipates a top-line readout for DENALI Part 2 at year-end 2026.
- Enrollment for the confirmatory Phase 3 ASPENOVA trial is planned to begin in the first half of 2026, designed to accelerate full approval and support accelerated approval efforts.
- Azenosertib is an oral, non-chemo agent targeting approximately 50% of PROC patients with high Cyclin E1 expression, demonstrating a manageable tolerability profile with 10% high-grade neutropenia and up to 35% overall response rate (ORR) and 6.3 months median duration of response.
- The TETON study in uterine serous carcinoma (USC) is fully enrolled, with data expected in 2026, though USC is not a top commercial priority for Zentalis.
Feb 11, 2026, 8:30 PM
Zentalis Pharmaceuticals Provides Update on Azenosertib Clinical Development
ZNTL
New Projects/Investments
Guidance Update
- Zentalis's core strategy is to rapidly advance azenosertib for patients with platinum-resistant ovarian cancer (PROC) who exhibit high Cyclin E1 expression.
- The DENALI Part 2 registration trial has completed enrollment for Part 2A, with a dose selection expected in the first half of 2026 and top-line data anticipated at year-end 2026.
- The confirmatory Phase 3 ASPENOVA trial is scheduled to enroll its first patient in the first half of 2026, designed as a randomized controlled trial against standard-of-care with the same eligibility as DENALI Part 2.
- Azenosertib is an oral, non-chemo option with a favorable tolerability profile, having demonstrated up to 35% overall response rate (ORR) and a 6.3 months median duration of response in historical studies, which exceeds the typical 30% ORR and 5-6 months duration for accelerated approval.
- An IHC assay for Cyclin E1 expression has been developed, and approximately 50% of PROC patients are expected to meet the eligibility cutoff for the trials.
Feb 11, 2026, 8:30 PM
Zentalis Pharmaceuticals Provides Corporate Update and Anticipated 2026 Milestones
ZNTL
Guidance Update
New Projects/Investments
- Zentalis Pharmaceuticals reported a strong cash position of $280.7 million as of September 30, 2025, which is expected to provide a runway into late 2027.
- In 2025, the company completed enrollment in DENALI Part 2a and aligned with the FDA on the design for the confirmatory ASPENOVA Phase 3 trial.
- Key milestones anticipated for 2026 include DENALI Part 2a dose confirmation in the first half of 2026, ASPENOVA Phase 3 trial initiation in the first half of 2026, and DENALI Part 2 topline readout by year-end 2026.
- The company's lead indication for azenosertib is Cyclin E1-positive platinum-resistant ovarian cancer (PROC), which is estimated to affect approximately 50% of PROC patients.
Jan 9, 2026, 10:18 PM
Zentalis Pharmaceuticals Provides 2026 Azenosertib Development Milestones and Financial Update
ZNTL
New Projects/Investments
Guidance Update
- Zentalis Pharmaceuticals provided a corporate update on its azenosertib development program, with key milestones for 2026 including expected DENALI Part 2a dose confirmation in 1H 2026 and the initiation of the ASPENOVA Phase 3 confirmatory trial in 1H 2026.
- The DENALI Part 2 topline readout is anticipated by year-end 2026, with the potential to support accelerated approval for azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer.
- The company reported a strong financial position with $280.7 million in cash, cash equivalents, and marketable securities as of September 30, 2025, providing an estimated cash runway into late 2027.
Jan 6, 2026, 1:00 PM
Zentalis Pharmaceuticals Announces Board Resignation and Share Repurchase
ZNTL
Board Change
Share Buyback
- Karan Takhar resigned from the Board of Directors of Zentalis Pharmaceuticals, Inc. on December 15, 2025, effective immediately, reducing the board size from seven to six directors.
- Zentalis Pharmaceuticals, Inc. repurchased 7,500,000 shares of its common stock from Matrix Capital Master Fund, LP at $1.33 per share on December 15, 2025. This price was a discount from the company's closing share price of $1.40 on December 12, 2025.
- The repurchase is connected to Matrix Capital Management Company L.P.'s plan to wind down its funds and is not expected to materially impact Zentalis's projected cash runway into late 2027.
Dec 15, 2025, 10:01 PM
ZNTL Provides Update on Azenosertib Development for Ovarian Cancer
ZNTL
New Projects/Investments
Guidance Update
- Zentalis (ZNTL) is focused on the late-stage development of its lead candidate, azenosertib, a potentially best-in-class, orally available non-chemotherapy for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). This patient population represents about 50% of the PROC market, or approximately 21,500 patients.
- Azenosertib has demonstrated encouraging efficacy with consistent response rates over 30% and a duration of response exceeding six months in these patients at the 400 milligram dose.
- The company has initiated Denali Part 2, a Phase 2 study designed for an accelerated approval pathway, with top-line data expected around year-end 2026.
- Key milestones for 2026 include dose selection for Denali and the initiation of the Phase 3 confirmatory trial.
- Zentalis's cash runway is projected to support development through late 2027, extending beyond the anticipated top-line data readout in 2026.
Nov 12, 2025, 1:00 PM
Zentalis Provides Update on Asenocertib Development for Platinum-Resistant Ovarian Cancer
ZNTL
New Projects/Investments
Guidance Update
- Zentalis (ZNTL) is focused on the late-stage development of its lead candidate, asenocertib, for cyclin E1 positive platinum-resistant ovarian cancer (PROC).
- The Phase 2 Denali Part 2 study is designed for an accelerated approval pathway, with reported response rates over 30% and duration of response exceeding six months in this patient population.
- The target market for asenocertib is estimated to be 50% of the PROC population, representing approximately 21,005 patients.
- Key upcoming milestones include initiating a Phase 3 confirmatory trial in 2026 and expecting top-line data from the Denali Part 2 trial by the end of 2026.
- Zentalis's cash runway is projected to support development through late 2027, extending beyond the 2026 top-line readout.
Nov 12, 2025, 1:00 PM
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