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SAN DIEGO - Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biotech company currently valued at $171 million, has shared promising clinical data from its studies of azenosertib, a small molecule therapeutic targeting Cyclin E1+ platinum-resistant ovarian cancer (PROC). According to InvestingPro data, the company’s stock has experienced significant volatility, declining over 80% in the past year. The company announced that the Objective Response Rate (ORR) in heavily-pretreated patients was approximately 35%, based on results from Part 1b of the DENALI study.
The company has also reached an agreement with the FDA on the design of DENALI Part 2, which is expected to begin in the first half of 2025, with topline data anticipated by the end of 2026. This study, if successful, may lead to an accelerated approval process. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 7.29, though it’s currently burning through cash reserves.
Azenosertib has been evaluated in solid tumors across multiple studies, including ZN-c3-001, MAMMOTH, and DENALI, showing a well-characterized safety profile with no new safety signals. The median duration of response was around 5.5 months, continuing to mature as patients remain on therapy.
Approximately 50% of PROC patients are Cyclin E1+, and Zentalis believes there is a significant therapeutic and commercial opportunity within this subset. The company’s restructuring, announced yesterday, extends its cash runway into late 2027, well beyond the expected data readout from DENALI Part 2.
The company plans to present detailed data from its clinical trials and provide regulatory updates at a corporate event today at 8:00 am ET. The event will be available via webcast on Zentalis’ website.
Azenosertib is a potentially first-in-class WEE1 inhibitor, which is a master regulator of the cell cycle. By inhibiting WEE1, azenosertib allows cell cycle progression despite DNA damage, leading to cancer cell death.
This report is based on a press release statement from Zentalis Pharmaceuticals. For deeper insights into Zentalis’s financial health and 10 additional exclusive ProTips, visit InvestingPro, where subscribers can access comprehensive analysis and real-time updates on the company’s performance metrics.
In other recent news, Zentalis Pharmaceuticals has announced key changes to its leadership team with the appointments of Wendy Chang as Chief People Officer and Haibo Wang as Chief Business Officer. This move comes as the company intensifies its efforts to advance azenosertib, its lead product candidate for treating gynecological malignancies. Analysts have recently revised their earnings expectations upward for the upcoming period, signaling optimism about the company’s financial prospects.
The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on Zentalis’s cancer drug, azeno, allowing the company to proceed with its planned clinical trials. This decision was commended by TD Cowen and Oppenheimer, both of which reaffirmed their positive ratings for the company. Zentalis is expected to reach several key milestones by the end of the year, including the release of various trial data.
Additionally, at its 2024 Annual Meeting of Stockholders, Zentalis ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024. Dr. Kimberly Blackwell and Dr. Enoch Kariuki were also elected to the company’s board. These are the latest developments in the ongoing story of Zentalis Pharmaceuticals.
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