Zentalis Pharmaceuticals'ZNTL shares have gained 28% over the past three months, fueled by investor optimism surrounding its lead oncology candidate, azenosertib.
Azenosertib Drives ZNTL's Ovarian Cancer Push
Azenosertib is Zentalis’ potential first-in-class WEE1 inhibitor being developed as a biomarker-driven oral therapy for ovarian cancer and additional tumor types. Based on interim data from part 2a, which demonstrated a favorable benefit-risk profile, Zentalis selected the 400 mg once-daily, 5-days-on/2-days-off (400 mg QD 5:2) regimen in April as the pivotal dose for azenosertib monotherapy for its registration-intended DENALI phase II clinical program to treat patients with cyclin E1-positive platinum-resistant ovarian cancer (PROC).
Management expects to complete enrollment across all DENALI part 2 cohorts and announce top-line data by the end of 2026, which could support an accelerated approval pathway, subject to positive data and FDA feedback.
Further supporting its regulatory strategy, Zentalis dosed the first patient in the phase III ASPENOVA confirmatory study in May. The study compares azenosertib monotherapy with the investigator's choice of standard-of-care chemotherapy in patients with cyclin E1-positive PROC and is designed to support the full FDA approval and potential global regulatory filings.
The FDA granted previously Fast Track Designation to azenosertib for the treatment of patients with cyclin E1-positive PROC.
Year to date, Zentalis shares have skyrocketed 278.5% compared with the industry’s 3% growth.
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Broadening Pipeline Boosts ZNTL's Prospects
Beyond its pivotal monotherapy program, the ongoing multi-part phase Ib MUIR study is evaluating azenosertib-based combination therapies in ovarian cancer to expand the candidate's potential beyond monotherapy. While part one is assessing azenosertib in combination with multiple chemotherapy regimens in patients with PROC, the currently enrolling part two dose-expansion cohort is evaluating azenosertib plus bevacizumab as a maintenance therapy for patients with second-line platinum-sensitive ovarian cancer whose disease progressed during first-line PARP inhibitor maintenance therapy.
Encouraging preclinical data showed that azenosertib combinations demonstrated activity in ADC-resistant triple-negative breast cancer (TNBC), supporting its expansion beyond ovarian cancer.
Zentalis Pharmaceuticals, Inc. Price and Consensus
Zentalis Pharmaceuticals, Inc. price-consensus-chart | Zentalis Pharmaceuticals, Inc. Quote
ZNTL’s Zacks Rank & Stocks to Consider
Zentalis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Neurocrine Biosciences NBIX, Amarin Corporation AMRN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 20.5% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 0.1% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have soared 131.8% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.
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Zentalis Pharmaceuticals, Inc. (ZNTL): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).