Zentalis Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2014-12-01
- Employees
- 168
- Market Cap
- $216.8M
- Website
- http://www.zentalis.com
- Introduction
Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which engages in discovering and developing clinically differentiated, novel small molecule therapeutics targeting fundamental biological pathways of cancer. It develops a broad pipeline of product candidates with an initial focus on validated oncology targets with the potential to address large patient populations. The company was founded by Kevin D. Bunker and Cam Gallagher on December 23, 2014 and is headquartered in San Diego, CA.
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FDA lifts partial clinical hold on Zentalis Pharma's cancer treatment azenosertib
The FDA lifted a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib, enabling continued cancer treatment evaluation. Zentalis’ stock rose 53% post-decision. Azenosertib, targeting WEE1 protein, showed promise in Phase Ib trials for ovarian cancer. Zentalis plans to present monotherapy data in 2024.
Related Clinical Trials:
Zentalis Pharmaceuticals Advances with FDA Approval and Upcoming Data
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FDA lifts hold on Zentalis cancer drug trials
Zentalis Pharmaceuticals announces FDA removal of partial clinical hold on azenosertib studies, allowing resumption of patient enrollment. Azenosertib, an orally bioavailable WEE1 inhibitor, targets gynecologic malignancies and is being evaluated in ovarian cancer and other tumor types. Zentalis plans to present monotherapy data and expects to meet 2024 data guidance. The company remains focused on advancing azenosertib and exploring protein degraders for high genomic instability tumors.
FDA Lifts Partial Clinical Hold on Trials Evaluating Azenosertib in Advanced Solid Tumors
The FDA has lifted the partial clinical hold on studies evaluating the WEE1 inhibitor azenosertib in advanced solid tumors. The hold was initially placed on the phase 1 ZN-c3-001 trial, phase 2 DENALI trial for platinum-resistant ovarian cancer, and phase 2 TETON trial for uterine serous carcinoma due to 2 deaths from presumed sepsis in the DENALI trial. After reviewing Zentalis Pharmaceuticals' complete response package, the FDA allowed the studies to resume without changes to the clinical development plan.
Zentalis Pharmaceuticals Announces FDA Has Lifted Partial Clinical Hold on Azenosertib Studies
FDA lifts partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing resumption of enrollment in ongoing clinical trials without changes to the development plan. Zentalis remains confident in azenosertib's therapeutic potential for gynecologic malignancies and plans to present monotherapy data later this year.
Zentalis Pharmaceuticals: Pioneering Small Molecule Therapeutics for Cancer
Zentalis is a clinical-stage biopharmaceutical company dedicated to discovering and developing small molecule therapeutics for cancer, aiming to improve patient lives through innovative treatments. They invite professionals to join their team to make a significant impact in cancer care.
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