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FDA puts Curis’ leukemia trial on partial hold after patient death spurs review of muscle breakdown

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.

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