Zentalis Pharmaceuticals, Inc. (ZNTL) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by th ...

Core Insights - The FDA has granted Fast Track Designation to azenosertib for treating platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients positive for Cyclin E1 [1][2] - Azenosertib is a selective WEE1 inhibitor being evaluated as a monotherapy and in combination therapies for various cancers, with a focus on gynecological malignancies [5][7] - A corporate event is scheduled for January 29, 2025, to present clinical data and regulatory updates regarding azenosertib [4] Company Overview - Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics targeting cancer pathways [7] - The lead product candidate, azenosertib, is positioned as a potentially first-in-class WEE1 inhibitor with broad franchise potential across multiple tumor types [7] - The company is exploring strategies to enrich patient populations for clinical trials, particularly targeting tumors with high genomic instability [7] Clinical Development - Azenosertib is currently being evaluated in several clinical trials, including monotherapy and combination studies, with a focus on high-grade serous ovarian cancer and PARP-resistant PROC [5][6] - The Phase 2 DENALI study has enrolled 102 patients, while the Phase 1b ZN-c3-001 trial has reported results from 69 PROC patients [5] - Initial data from the Phase 1 ZN-c3-016 trial in BRAF mutant metastatic colorectal cancer is also being presented [5] Research and Findings - Recent research published in npj Precision Oncology highlights the role of Cyclin E1/CDK2 activation in predicting sensitivity to azenosertib, supporting a biomarker-directed strategy for patient selection [2][3] - Preclinical models with high Cyclin E1 activation levels show increased sensitivity to azenosertib, indicating potential for targeted treatment approaches [3]

Overview of FMR LLC's Transaction - FMR LLC reduced its holdings in Zentalis Pharmaceuticals by 3,600,886 shares, bringing the total to 5,075,837 shares as of September 30, 2024, at a price of $3.68 per share [1] - This reduction reflects a strategic shift in FMR LLC's investment approach towards Zentalis Pharmaceuticals [1] Company Profile: Zentalis Pharmaceuticals - Zentalis Pharmaceuticals is focused on developing cancer therapeutics using its Integrated Discovery Engine to create small molecule new chemical entities [4] - The company has a market capitalization of $221.145 million and a current stock price of $3.11, indicating a significant decline from its IPO price [4] Financial Performance and Market Context - Zentalis Pharmaceuticals has faced a year-to-date price decline of 80.55% and an 87.56% drop since its IPO, highlighting the volatility in biotechnology investments [5] - The company's GF-Score is 31/100, indicating challenges in profitability and growth [5][6] Investment Implications - The decision by FMR LLC to reduce its stake in Zentalis is likely due to the company's poor financial and market performance [6] - The biotechnology sector remains competitive, and Zentalis must leverage its R&D to improve its financial standing and market position [6] Future Outlook - The prospects for Zentalis in the biotechnology sector appear cautious, necessitating critical evaluations of its pipeline products and market strategies [6] - Investors will be closely monitoring how Zentalis navigates its upcoming development phases and market adaptations [7]

Shares of Zentalis Pharmaceuticals (ZNTL) gained 13.6% on Monday after it announced that the FDA has lifted the partial clinical hold previously imposed on three studies of the company's lead product candidate, azenosertib, for three different cancer indications. The decision was based on the regulatory body's review of Zentalis' complete response package, which included a comprehensive safety assessment of the azenosertib program. Zentalis' azenosertib, a potentially first-in-class oral WEE1 inhibitor, is ...

Monday, the FDA lifted the partial clinical hold on studies of Zentalis Pharmaceuticals, Inc.'s ZNTL azenosertib, the company's novel, selective, and orally bioavailable inhibitor of WEE1. The FDA has cleared the company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan. Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible. Also Read: Zentalis Gea ...

SAN DIEGO, Sept. 16, 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 lifted the partial clinical hold on studies of azenosertib, the Company's novel, selective, and orally bioavailable inhibitor of WEE1. The FDA has cleared the Company to r ...

Company Overview - Zentalis Pharmaceuticals, Inc. (ZNTL) has experienced a significant stock decline of 71.7% over the past three months, contrasting with the industry growth of 6.2% [1] - The company is focused on developing azenosertib, a potential first-in-class WEE1 inhibitor, for various cancer treatments, including solid tumors and ovarian cancer [1] Clinical Trials and Regulatory Actions - In June 2024, the FDA imposed a partial clinical hold on three studies evaluating azenosertib for different cancer indications due to safety concerns [2][3] - The studies affected include the phase I ZN-c3-001 for solid tumors, the phase II ZN-c3-005 DENALI for platinum-resistant ovarian cancer, and the phase II ZN-c3-004 TETON for uterine serous carcinoma [2] - The hold was triggered after two patient deaths in the DENALI study, presumed to be due to sepsis, which likely contributed to the stock's decline [3] Upcoming Data and Studies - Top-line data from cohort 1b of the DENALI study is anticipated in the second half of 2024, with additional data from the ZN-c3-001 and MAMMOTH studies expected later this year [3][6] - The phase I/II MAMMOTH study is evaluating azenosertib in combination with GSK's PARP inhibitor Zejula and as a monotherapy for treating platinum-resistant ovarian cancer [4] Financial Position - As of June 30, 2024, Zentalis reported cash, cash equivalents, and marketable securities totaling $426.4 million, which is projected to fund operations into mid-2026 [6] Recent Developments - Zentalis has discontinued the development of its BCL-2 inhibitor, ZN-d5, which was being evaluated in combination with azenosertib for acute myeloid leukemia [5]

$426.4M cash, cash equivalents and marketable securities as of June 30, 2024; Projected cash runway into mid-2026 SAN DIEGO, Aug. 09, 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 financial results for the quarter ended June 30, 2024, and highlighted recent corporate accomplishments. "While ...

Core Viewpoint - Zentalis Pharmaceuticals, Inc. is under investigation due to a partial clinical hold placed by the FDA on its studies involving azenosertib, which has led to a decline in its stock price [2]. Investigation Details - On June 18, 2024, Zentalis announced that the FDA had placed a partial clinical hold on three studies: 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, and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma [2]. Next Steps - Investors who have information related to the investigation or who purchased Zentalis securities are encouraged to assist by visiting the law firm's website or contacting their representatives [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if they are successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm specializing in representing investors in securities fraud class actions and has recovered hundreds of millions of dollars for investors across the nation [5].

NEW YORK, July 25, 2024 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. Why Your Participation Matters: For additional information, please visit Shareholder Derivative Litigation - Kuehn Law. Contacts: Kuehn Law, ...