FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths

1. FDA Partial Clinical Hold: The FDA has placed a partial clinical hold on three cancer studies for Zentalis Pharmaceuticals' lead candidate, azenosertib, following two patient deaths due to presumed sepsis.
2. Studies Affected: The hold impacts a Phase I dose escalation study in solid tumors, a Phase II trial in platinum-resistant ovarian cancer (PROC), and a Phase II study in uterine serous carcinoma (USC).
3. Patient Deaths: The two deaths occurred in the Phase II DENALI study, which was evaluating azenosertib in patients with platinum-resistant ovarian cancer.
4. Patient Safety: Zentalis CEO Kimberly Blackwell emphasized that patient safety is the company's top priority and that they are working closely with the FDA to resolve the partial clinical hold.
5. Azenosertib Development: Azenosertib is a first-in-class small molecule WEE1 inhibitor being tested as a monotherapy and in combination with traditional chemotherapy and DNA damaging agents.
6. Future Data: Safety and efficacy data from Cohort 1b of the DENALI study are expected later this year, and the company remains on track to report topline results from other studies in 2024.
7. Stock Impact: Zentalis' stock price plummeted around 30% following the announcement.