The list of biotechs under clinical hold keeps getting longer. Curis is the latest company to join the list, with the FDA slapping a partial hold on a phase 1/2a leukemia study while it gathers information about the death of a patient.
Massachusetts-based Curis is running the TakeAim Leukemia study to evaluate different doses of IRAK4 kinase inhibitor emavusertib as a monotherapy and in combination with azacitidine or venetoclax. The clinical trial was enrolling patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome before the FDA got wind of a safety signal.