Zentalis Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, 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 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.
“We are grateful to the FDA for their collaboration and review of our complete response package, which included a comprehensive safety assessment of the azenosertib program,” said Kimberly Blackwell, M.D., Chief Executive Officer. “We are extremely pleased with the successful resolution of the partial clinical hold. Our confidence in the therapeutic index of azenosertib has been unwavering, and we continue to believe in the potential for this treatment to address unmet medical needs faced by people living with gynecologic malignancies.”
At a corporate event later this year, Zentalis will present azenosertib monotherapy data and provide additional updates to azenosertib clinical development and other data presentation timelines. The Company remains on track to meet all previously disclosed data guidance for the remainder of 2024.