Zentalis Pharmaceuticals (ZNTL) FDA Approvals $4.06 -0.08 (-1.93%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$4.00 -0.06 (-1.38%) As of 05/22/2026 06:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Zentalis Pharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Zentalis Pharmaceuticals (ZNTL). Over the past two years, Zentalis Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as azenosertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Azenosertib FDA Regulatory Timeline and Events Azenosertib is a drug developed by Zentalis Pharmaceuticals for the following indication: Wee1 inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Data - May 21,2026Data Phase 1bDrug: azenosertibAnnounced Date: May 21, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois.AI SummaryZentalis Pharmaceuticals said data from Part 1 of its Phase 1b MUIR trial will be presented at the 2026 ASCO Annual Meeting in Chicago from May 29 to June 2, 2026. The study tested azenosertib, the company’s WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant ovarian cancer. In 46 patients across four dose groups, the trial showed encouraging activity compared with historical paclitaxel alone. In the all-comer group, the overall response rate was about 30% and median progression-free survival was about 4 months. Results were also similar in Cyclin E1-positive and Cyclin E1-negative patients, suggesting the biomarker may not be required for benefit when azenosertib is combined with chemotherapy. At the 250 mg intermittent dose cohort, the company said the treatment appeared to have a manageable safety profile and a possible favorable balance of benefit and tolerability. The poster will be posted on Zentalis’ website after ASCO.Read AnnouncementDose Update - May 5,2026Dose Update Phase 3Drug: azenosertibAnnounced Date: May 5, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. nnounced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).AI SummaryZentalis Pharmaceuticals announced that the first patient has been dosed in the Phase 3 ASPENOVA trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27). ASPENOVA is a global, randomized, controlled study comparing azenosertib to standard-of-care chemotherapy in patients with Cyclin E1–positive platinum-resistant ovarian cancer (PROC). The trial is intended as a confirmatory study to support the company’s DENALI Phase 2 accelerated approval pathway, subject to FDA feedback. ASPENOVA aims to provide definitive evidence of azenosertib’s benefit over existing treatments in this hard-to-treat patient group. The study is being run in collaboration with The GOG Foundation, ENGOT and APGOT, reflecting international support for addressing the unmet needs of PROC patients. Enrollment is underway, marking a key step toward potential regulatory submission if results are positive.Read AnnouncementPoster Presentation - March 17,2026Poster Presentation Drug: azenosertibAnnounced Date: March 17, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.AI SummaryZentalis Pharmaceuticals announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 in San Diego. The company will share preclinical and real‑world data addressing targeted therapy approaches for difficult‑to‑treat cancers, highlighting a WEE1 inhibitor program and clinical patterns in ovarian cancer. The first poster, “WEE1 Inhibition as a Therapeutic Strategy in Triple‑Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models” (Abstract 2012), will be presented by Alexandra Levy, MS, on Monday, April 20, 2026, from 2:00 p.m. to 5:00 p.m. PDT. It reports laboratory studies of azenosertib’s activity alone and in combinations against triple‑negative breast cancer models. The second poster, “Real‑World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1‑Positive Ovarian Cancer” (Abstract 1708), will be presented by Jinkil Jeong, PhD, on Sunday, April 19, 2026, from 2:00 p.m. to 5:00 p.m. PDT. This analysis examines treatment patterns and outcomes in patients with cyclin E1‑positive ovarian cancer.Read AnnouncementProvided Update - January 6,2026Provided Update Drug: azenosertibAnnounced Date: January 6, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. today provided a corporate update and highlighted key milestones and expected momentum in the azenosertib development program for 2026.AI SummaryZentalis Pharmaceuticals provided a 2026 update for azenosertib, its investigational oral WEE1 inhibitor. The company completed enrollment in DENALI Part 2a and expects dose confirmation in the first half of 2026. They plan to start ASPENOVA, a randomized Phase 3 confirmatory trial versus standard chemotherapy, also in the first half of 2026. DENALI Part 2 topline results are expected by year-end 2026 and, if positive, could support an accelerated approval pathway. Azenosertib is being developed as a targeted, non‑chemo option for Cyclin E1–positive platinum‑resistant ovarian cancer, a group Zentalis estimates comprises roughly 50% of PROC patients. The company reported encouraging earlier DENALI data and a manageable safety profile at the 400 mg 5:2 dose schedule. Zentalis also said it has financial resources expected to provide runway into late 2027 to support these development plans.Read AnnouncementDose Update - April 28,2025Dose Update Phase 2Drug: azenosertibAnnounced Date: April 28, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).AI SummaryZentalis® Pharmaceuticals, Inc. announced a significant milestone in its clinical study for ovarian cancer treatment. The first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825), which is testing azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer. In close cooperation with the FDA, the trial design allows seamless enrollment into two parts. Part 2a is confirming the primary dose with about 30 patients planned for each of the two dosing levels, while Part 2b will enroll an additional 70 patients at the dose selected based on early results and FDA feedback. Topline data are anticipated by the end of 2026. If successful, the trial may support an accelerated approval, potentially offering a new treatment option for women suffering from this challenging form of ovarian cancer.Read AnnouncementTop-line data - April 28,2025Top-Line Data Drug: azenosertibAnnounced Date: April 28, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedbackAI SummaryZentalis® Pharmaceuticals, Inc. announced that topline data from the Phase 2 DENALI trial is expected by the end of 2026. The results from this study could support accelerated approval of their novel cancer treatment, azenosertib, pending favorable FDA feedback. The DENALI trial, aimed at patients with Cyclin E1+ platinum-resistant ovarian cancer, is designed in two parts. Part 2 will first confirm the most promising dose levels, and then further evaluate safety and effectiveness at the chosen dose. This approach is expected to streamline the study and provide clear insights into the treatment’s potential benefits. If the upcoming data shows positive results, it could lead to faster regulatory approval, making azenosertib available sooner to patients who face limited treatment options for advanced ovarian cancer.Read AnnouncementClinical Data - March 15,2025Clinical Data Phase 1bDrug: azenosertibAnnounced Date: March 15, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer.AI SummaryZentalis Pharmaceuticals recently presented updated data from Part 1b of its ongoing DENALI clinical trial at the SGO 2025 Annual Meeting on Women’s Cancer. The study focused on azenosertib in patients with platinum-resistant ovarian cancer, specifically analyzing those with Cyclin E1 overexpression. Updated results showed a median duration of response of 6.3 months and an objective response rate of approximately 35% in response-evaluable patients. These promising findings highlight the potential of azenosertib as a treatment option for this hard-to-treat patient group. The trial used a 400mg dose administered on an intermittent schedule, and the data also supports Cyclin E1 as a useful biomarker to identify patients who may benefit most from this therapy. Encouraged by the results, the company is on track to initiate Part 2 of the trial in early 2025, with topline data anticipated by the end of 2026.Read AnnouncementPresentation - March 3,2025Presentation Phase 2Drug: azenosertibAnnounced Date: March 3, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals announced multiple presentations, including an oral presentation with updated clinical data from the ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC), at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, to be held on March 14-17 in Seattle, Washington.,AI SummaryZentalis® Pharmaceuticals announced that it will present updated clinical data from its ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer in Seattle, Washington, from March 14–17, 2025. Dr. Fiona Simpkins will deliver an oral presentation on March 15 at 8:25 am PST, discussing how Cyclin E1 can serve as a predictive biomarker for azenosertib benefit in PROC patients, based on outcomes from Part 1b of the DENALI Study. Additionally, the company will share preclinical evidence of azenosertib’s enhanced antitumor effects when combined with microtubule inhibitor-based antibody drug conjugates. This session further highlights the potential of azenosertib as a promising treatment option for patients with platinum-resistant ovarian cancer.Read AnnouncementStudy Initiation - January 29,2025Study Initiation Drug: azenosertibAnnounced Date: January 29, 2025Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Company aligned with FDA on seamless study design for DENALI Part 2 in patients with Cyclin E1+ PROC; study expected to begin 1H 2025AI SummaryZentalis Pharmaceuticals announced that it has aligned with the FDA on a seamless design for its upcoming DENALI Part 2 study in patients with Cyclin E1+ platinum‐resistant ovarian cancer. This next phase of the trial is structured in two parts: Part 2a aims to confirm the key dose-of-interest using two dosing levels (400mg QD 5:2 and 300mg QD 5:2) with approximately 30 patients at each level. Part 2b will then enroll around 70 patients at the dose selected based on Part 2a’s outcomes, with final endpoints subject to further FDA guidance. The study is expected to start enrolling patients in the first half of 2025, and topline data is anticipated by the end of 2026. If the trial successfully demonstrates clear efficacy and safety, it could potentially support an accelerated approval, offering a new treatment option for this challenging patient population.Read AnnouncementUpdated data - January 29,2025Updated Data Drug: azenosertibAnnounced Date: January 29, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. today presented updated azenosertib monotherapy clinical data from its ZN-c3-001, MAMMOTH and DENALI studies and shared details on future clinical development and potential registration plans for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).AI SummaryZentalis® Pharmaceuticals presented updated clinical data for its azenosertib monotherapy from the ZN-c3-001, MAMMOTH, and DENALI studies. The data shows promising results for patients with Cyclin E1+ platinum-resistant ovarian cancer, reporting an objective response rate of about 35% and a median duration of response of roughly 5.5 months. These encouraging findings support the potential of azenosertib as a treatment option for a patient population with significant unmet needs. The company also shared its future clinical development plans, including details on the DENALI Part 2 study. This new study, which has been aligned with the FDA for a seamless design, will begin enrolling patients in the first half of 2025. Topline data from this registration-intent trial is expected by the end of 2026, and if successful, the study may support an accelerated approval pathway.Read AnnouncementTop-line data - January 29,2025Top-Line Data Drug: azenosertibAnnounced Date: January 29, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Topline data from registration-intent DENALI Part 2 anticipated by year end 2026AI SummaryZentalis Pharmaceuticals announced that it has aligned with the FDA on the seamless design for its DENALI Part 2 study, which targets patients with Cyclin E1+ platinum-resistant ovarian cancer. The trial is divided into two parts: Part 2a will help confirm the optimal dose, and Part 2b will enroll additional patients based on those results. The company plans to start enrollment in the first half of 2025. Topline data from this registration-intent trial is anticipated by the end of 2026. If the study meets its endpoints, the results could support accelerated approval for the therapy. This new approach marks an important step toward offering patients with this difficult-to-treat form of ovarian cancer a promising treatment option, addressing a critical unmet need in this patient population.Read AnnouncementDesignation Grant - January 9,2025Designation Grant Fast TrackDrug: azenosertibAnnounced Date: January 9, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc announced that the FDA has granted Fast Track Designation to azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who are positive via Cyclin E1 immunohistochemistry for protein levels.AI SummaryZentalis® Pharmaceuticals has received Fast Track Designation from the FDA for its investigational drug azenosertib. This designation targets patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who show high levels of Cyclin E1 protein via immunohistochemistry. The Fast Track status is designed to speed up the development and review process for treatments that address serious conditions and unmet medical needs. This decision highlights the urgent need for more effective treatments in this patient population, as these cancers have historically been difficult to treat with standard chemotherapy. Zentalis believes that azenosertib, which works by inhibiting WEE1 to disrupt cancer cell cycles, could offer a new therapeutic option for these patients. The company continues to advance clinical studies that may lead to quicker access to this targeted therapy for individuals with Cyclin E1 positive cancers.Read AnnouncementLifted Clinical Hold - September 16,2024Lifted Clinical Hold Drug: azenosertibAnnounced Date: September 16, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies of azenosertib, the Company's novel, selective, and orally bioavailable inhibitor of WEE1.AI SummaryZentalis Pharmaceuticals announced that the FDA has lifted the partial clinical hold on its studies of azenosertib, a novel, selective, and orally available inhibitor of WEE1. This decision allows the company to resume enrollment in all ongoing clinical studies without any changes to its clinical development plan. Zentalis is now working closely with clinical trial investigators to quickly restart study activities across its azenosertib program. Dr. Kimberly Blackwell, CEO of Zentalis, expressed gratitude for the FDA’s thorough review and collaborative approach, emphasizing that the complete safety assessment was crucial in resolving the hold. The company remains confident in the therapeutic potential of azenosertib, particularly for patients facing gynecologic cancers. Zentalis plans to share updated clinical data on azenosertib later this year, reinforcing its commitment to addressing unmet medical needs in cancer treatment.Read AnnouncementData Presentation - September 9,2024Data Presentation Drug: azenosertibAnnounced Date: September 9, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the company will present preclinical data from its selective WEE1 inhibitor azenosertib at the European Society of Medical Oncology (ESMO) 2024 Congress, occurring September 13-17 in Barcelona, Spain.AI SummaryZentalis Pharmaceuticals, Inc. announced it will showcase preclinical data at the European Society of Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain, from September 13 to 17. The data focuses on azenosertib, the company’s selective WEE1 inhibitor, and its potential when paired with other cancer therapies. Preclinical studies have shown that azenosertib, in combination with topoisomerase I inhibitors and antibody-drug conjugates (ADCs), can enhance antitumor effects. In several models, including HER2-positive breast and ovarian cancers, the combination led to significantly improved outcomes, such as complete tumor regression in some cases. These promising results, which will be detailed in Poster #35P by Jianhui Ma on September 15, highlight a potential new therapeutic approach for treating advanced solid tumors.Read AnnouncementClinical Hold - June 18,2024Clinical Hold Drug: azenosertibAnnounced Date: June 18, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. 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 Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). This action follows two recent deaths due to presumed sepsis in the DENALI study.AI SummaryZentalis® Pharmaceuticals, Inc. announced that the FDA has placed a partial clinical hold on its studies of azenosertib due to two recent deaths from presumed sepsis in the DENALI trial. The halted studies include the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 DENALI study for platinum-resistant ovarian cancer, and the Phase 2 TETON study for uterine serous carcinoma. Patient safety is a top priority, and the company is working closely with the FDA to resolve the issue quickly. Despite these events, over 500 patients have received azenosertib monotherapy to date, and preliminary data suggest that the treatment demonstrates a favorable therapeutic index, potentially benefiting women with PROC and USC. The company plans to further present monotherapy data in the second half of 2024, and additional updates on the clinical development timeline will follow once the partial hold is resolved.Read Announcement Zentalis Pharmaceuticals FDA Events - Frequently Asked Questions Has Zentalis Pharmaceuticals received FDA approval? As of now, Zentalis Pharmaceuticals (ZNTL) has not received any FDA approvals for its therapy in the last two years. What drugs has Zentalis Pharmaceuticals submitted to the FDA? In the past two years, Zentalis Pharmaceuticals (ZNTL) has reported FDA regulatory activity for azenosertib. What is the most recent FDA event for Zentalis Pharmaceuticals? The most recent FDA-related event for Zentalis Pharmaceuticals occurred on May 21, 2026, involving azenosertib. The update was categorized as "Data," with the company reporting: "Zentalis® Pharmaceuticals, Inc. announced that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois." What conditions do Zentalis Pharmaceuticals' current drugs treat? Currently, Zentalis Pharmaceuticals has one therapy (azenosertib) targeting the following condition: Wee1 inhibitor.. 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Data - May 21,2026Data Phase 1bDrug: azenosertibAnnounced Date: May 21, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that data from Part 1 of the Phase 1b MUIR trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago, Illinois.AI SummaryZentalis Pharmaceuticals said data from Part 1 of its Phase 1b MUIR trial will be presented at the 2026 ASCO Annual Meeting in Chicago from May 29 to June 2, 2026. The study tested azenosertib, the company’s WEE1 inhibitor, in combination with chemotherapy in patients with platinum-resistant ovarian cancer. In 46 patients across four dose groups, the trial showed encouraging activity compared with historical paclitaxel alone. In the all-comer group, the overall response rate was about 30% and median progression-free survival was about 4 months. Results were also similar in Cyclin E1-positive and Cyclin E1-negative patients, suggesting the biomarker may not be required for benefit when azenosertib is combined with chemotherapy. At the 250 mg intermittent dose cohort, the company said the treatment appeared to have a manageable safety profile and a possible favorable balance of benefit and tolerability. The poster will be posted on Zentalis’ website after ASCO.Read Announcement
Dose Update - May 5,2026Dose Update Phase 3Drug: azenosertibAnnounced Date: May 5, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. nnounced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).AI SummaryZentalis Pharmaceuticals announced that the first patient has been dosed in the Phase 3 ASPENOVA trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27). ASPENOVA is a global, randomized, controlled study comparing azenosertib to standard-of-care chemotherapy in patients with Cyclin E1–positive platinum-resistant ovarian cancer (PROC). The trial is intended as a confirmatory study to support the company’s DENALI Phase 2 accelerated approval pathway, subject to FDA feedback. ASPENOVA aims to provide definitive evidence of azenosertib’s benefit over existing treatments in this hard-to-treat patient group. The study is being run in collaboration with The GOG Foundation, ENGOT and APGOT, reflecting international support for addressing the unmet needs of PROC patients. Enrollment is underway, marking a key step toward potential regulatory submission if results are positive.Read Announcement
Poster Presentation - March 17,2026Poster Presentation Drug: azenosertibAnnounced Date: March 17, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.AI SummaryZentalis Pharmaceuticals announced two poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 in San Diego. The company will share preclinical and real‑world data addressing targeted therapy approaches for difficult‑to‑treat cancers, highlighting a WEE1 inhibitor program and clinical patterns in ovarian cancer. The first poster, “WEE1 Inhibition as a Therapeutic Strategy in Triple‑Negative Breast Cancer: Evaluating Single Agent and Combination Activity of Azenosertib in Preclinical Models” (Abstract 2012), will be presented by Alexandra Levy, MS, on Monday, April 20, 2026, from 2:00 p.m. to 5:00 p.m. PDT. It reports laboratory studies of azenosertib’s activity alone and in combinations against triple‑negative breast cancer models. The second poster, “Real‑World Treatment Patterns and Outcomes Reveal Distinct Clinical Trajectories of Patients with Cyclin E1‑Positive Ovarian Cancer” (Abstract 1708), will be presented by Jinkil Jeong, PhD, on Sunday, April 19, 2026, from 2:00 p.m. to 5:00 p.m. PDT. This analysis examines treatment patterns and outcomes in patients with cyclin E1‑positive ovarian cancer.Read Announcement
Provided Update - January 6,2026Provided Update Drug: azenosertibAnnounced Date: January 6, 2026Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. today provided a corporate update and highlighted key milestones and expected momentum in the azenosertib development program for 2026.AI SummaryZentalis Pharmaceuticals provided a 2026 update for azenosertib, its investigational oral WEE1 inhibitor. The company completed enrollment in DENALI Part 2a and expects dose confirmation in the first half of 2026. They plan to start ASPENOVA, a randomized Phase 3 confirmatory trial versus standard chemotherapy, also in the first half of 2026. DENALI Part 2 topline results are expected by year-end 2026 and, if positive, could support an accelerated approval pathway. Azenosertib is being developed as a targeted, non‑chemo option for Cyclin E1–positive platinum‑resistant ovarian cancer, a group Zentalis estimates comprises roughly 50% of PROC patients. The company reported encouraging earlier DENALI data and a manageable safety profile at the 400 mg 5:2 dose schedule. Zentalis also said it has financial resources expected to provide runway into late 2027 to support these development plans.Read Announcement
Dose Update - April 28,2025Dose Update Phase 2Drug: azenosertibAnnounced Date: April 28, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).AI SummaryZentalis® Pharmaceuticals, Inc. announced a significant milestone in its clinical study for ovarian cancer treatment. The first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825), which is testing azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer. In close cooperation with the FDA, the trial design allows seamless enrollment into two parts. Part 2a is confirming the primary dose with about 30 patients planned for each of the two dosing levels, while Part 2b will enroll an additional 70 patients at the dose selected based on early results and FDA feedback. Topline data are anticipated by the end of 2026. If successful, the trial may support an accelerated approval, potentially offering a new treatment option for women suffering from this challenging form of ovarian cancer.Read Announcement
Top-line data - April 28,2025Top-Line Data Drug: azenosertibAnnounced Date: April 28, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedbackAI SummaryZentalis® Pharmaceuticals, Inc. announced that topline data from the Phase 2 DENALI trial is expected by the end of 2026. The results from this study could support accelerated approval of their novel cancer treatment, azenosertib, pending favorable FDA feedback. The DENALI trial, aimed at patients with Cyclin E1+ platinum-resistant ovarian cancer, is designed in two parts. Part 2 will first confirm the most promising dose levels, and then further evaluate safety and effectiveness at the chosen dose. This approach is expected to streamline the study and provide clear insights into the treatment’s potential benefits. If the upcoming data shows positive results, it could lead to faster regulatory approval, making azenosertib available sooner to patients who face limited treatment options for advanced ovarian cancer.Read Announcement
Clinical Data - March 15,2025Clinical Data Phase 1bDrug: azenosertibAnnounced Date: March 15, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer.AI SummaryZentalis Pharmaceuticals recently presented updated data from Part 1b of its ongoing DENALI clinical trial at the SGO 2025 Annual Meeting on Women’s Cancer. The study focused on azenosertib in patients with platinum-resistant ovarian cancer, specifically analyzing those with Cyclin E1 overexpression. Updated results showed a median duration of response of 6.3 months and an objective response rate of approximately 35% in response-evaluable patients. These promising findings highlight the potential of azenosertib as a treatment option for this hard-to-treat patient group. The trial used a 400mg dose administered on an intermittent schedule, and the data also supports Cyclin E1 as a useful biomarker to identify patients who may benefit most from this therapy. Encouraged by the results, the company is on track to initiate Part 2 of the trial in early 2025, with topline data anticipated by the end of 2026.Read Announcement
Presentation - March 3,2025Presentation Phase 2Drug: azenosertibAnnounced Date: March 3, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals announced multiple presentations, including an oral presentation with updated clinical data from the ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC), at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, to be held on March 14-17 in Seattle, Washington.,AI SummaryZentalis® Pharmaceuticals announced that it will present updated clinical data from its ongoing Phase 2 DENALI clinical trial of azenosertib in patients with platinum-resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women’s Cancer in Seattle, Washington, from March 14–17, 2025. Dr. Fiona Simpkins will deliver an oral presentation on March 15 at 8:25 am PST, discussing how Cyclin E1 can serve as a predictive biomarker for azenosertib benefit in PROC patients, based on outcomes from Part 1b of the DENALI Study. Additionally, the company will share preclinical evidence of azenosertib’s enhanced antitumor effects when combined with microtubule inhibitor-based antibody drug conjugates. This session further highlights the potential of azenosertib as a promising treatment option for patients with platinum-resistant ovarian cancer.Read Announcement
Study Initiation - January 29,2025Study Initiation Drug: azenosertibAnnounced Date: January 29, 2025Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Company aligned with FDA on seamless study design for DENALI Part 2 in patients with Cyclin E1+ PROC; study expected to begin 1H 2025AI SummaryZentalis Pharmaceuticals announced that it has aligned with the FDA on a seamless design for its upcoming DENALI Part 2 study in patients with Cyclin E1+ platinum‐resistant ovarian cancer. This next phase of the trial is structured in two parts: Part 2a aims to confirm the key dose-of-interest using two dosing levels (400mg QD 5:2 and 300mg QD 5:2) with approximately 30 patients at each level. Part 2b will then enroll around 70 patients at the dose selected based on Part 2a’s outcomes, with final endpoints subject to further FDA guidance. The study is expected to start enrolling patients in the first half of 2025, and topline data is anticipated by the end of 2026. If the trial successfully demonstrates clear efficacy and safety, it could potentially support an accelerated approval, offering a new treatment option for this challenging patient population.Read Announcement
Updated data - January 29,2025Updated Data Drug: azenosertibAnnounced Date: January 29, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. today presented updated azenosertib monotherapy clinical data from its ZN-c3-001, MAMMOTH and DENALI studies and shared details on future clinical development and potential registration plans for patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC).AI SummaryZentalis® Pharmaceuticals presented updated clinical data for its azenosertib monotherapy from the ZN-c3-001, MAMMOTH, and DENALI studies. The data shows promising results for patients with Cyclin E1+ platinum-resistant ovarian cancer, reporting an objective response rate of about 35% and a median duration of response of roughly 5.5 months. These encouraging findings support the potential of azenosertib as a treatment option for a patient population with significant unmet needs. The company also shared its future clinical development plans, including details on the DENALI Part 2 study. This new study, which has been aligned with the FDA for a seamless design, will begin enrolling patients in the first half of 2025. Topline data from this registration-intent trial is expected by the end of 2026, and if successful, the study may support an accelerated approval pathway.Read Announcement
Top-line data - January 29,2025Top-Line Data Drug: azenosertibAnnounced Date: January 29, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that Topline data from registration-intent DENALI Part 2 anticipated by year end 2026AI SummaryZentalis Pharmaceuticals announced that it has aligned with the FDA on the seamless design for its DENALI Part 2 study, which targets patients with Cyclin E1+ platinum-resistant ovarian cancer. The trial is divided into two parts: Part 2a will help confirm the optimal dose, and Part 2b will enroll additional patients based on those results. The company plans to start enrollment in the first half of 2025. Topline data from this registration-intent trial is anticipated by the end of 2026. If the study meets its endpoints, the results could support accelerated approval for the therapy. This new approach marks an important step toward offering patients with this difficult-to-treat form of ovarian cancer a promising treatment option, addressing a critical unmet need in this patient population.Read Announcement
Designation Grant - January 9,2025Designation Grant Fast TrackDrug: azenosertibAnnounced Date: January 9, 2025Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc announced that the FDA has granted Fast Track Designation to azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PROC) who are positive via Cyclin E1 immunohistochemistry for protein levels.AI SummaryZentalis® Pharmaceuticals has received Fast Track Designation from the FDA for its investigational drug azenosertib. This designation targets patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who show high levels of Cyclin E1 protein via immunohistochemistry. The Fast Track status is designed to speed up the development and review process for treatments that address serious conditions and unmet medical needs. This decision highlights the urgent need for more effective treatments in this patient population, as these cancers have historically been difficult to treat with standard chemotherapy. Zentalis believes that azenosertib, which works by inhibiting WEE1 to disrupt cancer cell cycles, could offer a new therapeutic option for these patients. The company continues to advance clinical studies that may lead to quicker access to this targeted therapy for individuals with Cyclin E1 positive cancers.Read Announcement
Lifted Clinical Hold - September 16,2024Lifted Clinical Hold Drug: azenosertibAnnounced Date: September 16, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies of azenosertib, the Company's novel, selective, and orally bioavailable inhibitor of WEE1.AI SummaryZentalis Pharmaceuticals announced that the FDA has lifted the partial clinical hold on its studies of azenosertib, a novel, selective, and orally available inhibitor of WEE1. This decision allows the company to resume enrollment in all ongoing clinical studies without any changes to its clinical development plan. Zentalis is now working closely with clinical trial investigators to quickly restart study activities across its azenosertib program. Dr. Kimberly Blackwell, CEO of Zentalis, expressed gratitude for the FDA’s thorough review and collaborative approach, emphasizing that the complete safety assessment was crucial in resolving the hold. The company remains confident in the therapeutic potential of azenosertib, particularly for patients facing gynecologic cancers. Zentalis plans to share updated clinical data on azenosertib later this year, reinforcing its commitment to addressing unmet medical needs in cancer treatment.Read Announcement
Data Presentation - September 9,2024Data Presentation Drug: azenosertibAnnounced Date: September 9, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. announced that the company will present preclinical data from its selective WEE1 inhibitor azenosertib at the European Society of Medical Oncology (ESMO) 2024 Congress, occurring September 13-17 in Barcelona, Spain.AI SummaryZentalis Pharmaceuticals, Inc. announced it will showcase preclinical data at the European Society of Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain, from September 13 to 17. The data focuses on azenosertib, the company’s selective WEE1 inhibitor, and its potential when paired with other cancer therapies. Preclinical studies have shown that azenosertib, in combination with topoisomerase I inhibitors and antibody-drug conjugates (ADCs), can enhance antitumor effects. In several models, including HER2-positive breast and ovarian cancers, the combination led to significantly improved outcomes, such as complete tumor regression in some cases. These promising results, which will be detailed in Poster #35P by Jianhui Ma on September 15, highlight a potential new therapeutic approach for treating advanced solid tumors.Read Announcement
Clinical Hold - June 18,2024Clinical Hold Drug: azenosertibAnnounced Date: June 18, 2024Indication: Wee1 inhibitor.AnnouncementZentalis® Pharmaceuticals, Inc. 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 Phase 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). This action follows two recent deaths due to presumed sepsis in the DENALI study.AI SummaryZentalis® Pharmaceuticals, Inc. announced that the FDA has placed a partial clinical hold on its studies of azenosertib due to two recent deaths from presumed sepsis in the DENALI trial. The halted studies include the Phase 1 ZN-c3-001 dose-escalation study in solid tumors, the Phase 2 DENALI study for platinum-resistant ovarian cancer, and the Phase 2 TETON study for uterine serous carcinoma. Patient safety is a top priority, and the company is working closely with the FDA to resolve the issue quickly. Despite these events, over 500 patients have received azenosertib monotherapy to date, and preliminary data suggest that the treatment demonstrates a favorable therapeutic index, potentially benefiting women with PROC and USC. The company plans to further present monotherapy data in the second half of 2024, and additional updates on the clinical development timeline will follow once the partial hold is resolved.Read Announcement
