Grandbrothers/iStock Editorial via Getty Images Zentalis ( NASDAQ: ZNTL ) announced Tuesday that the U.S. FDA placed a partial clinical hold on several studies involving its lead candidate, azenosertib after two trial participants died in one of those studies.
Shares of the New York-based biotech fell ~27% following a brief trading halt after the announcement. The partial clinical hold will be applicable for 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 (PROC), and the Phase 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC). The FDA’s decision comes after two subjects in the DENALI study died recently, which Zentalis ( ZNTL ) attributed to a medical condition known as sepsis.
However, the company remains on track to present results from the ZN-c3-001 study and another trial called Phase 1/2 ZN-c3-006 (MAMMOTH) involving azenosertib in H2 2024. Meanwhile, overall efficacy and safety data from Cohort 1b of DENALI are also expected later this year. “We are working closely with the FDA to resolve this partial clinical hold as quickly as possible,” CEO Kimberly Blackwell remarked.
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