Zentalis' shares plunge 30% after FDA places WEE1 drug on partial hold over sepsis deaths

The FDA has placed three trials of Zentalis’ WEE1 candidate on partial hold in the wake of two deaths that are presumed to be from sepsis.

The fatalities occurred in the phase 2 DENALI study, which was evaluating the synthetic lethal WEE1 inhibitor azenosertib in patients with platinum-resistant ovarian cancer. The hold also extends to the other studies of azenosertib as a monotherapy—a phase 2 trial in uterine serous carcinoma and a phase 1 dose-escalation study in solid tumors.