FDA lifts partial hold on Curis' PhI/II leukemia study as biotech raises $15M
Curis can now go full speed ahead with its leukemia trial after the FDA had imposed a partial clinical hold on the biotech last year due to a patient death.
The company announced Thursday that the FDA lifted a partial clinical hold on a Phase I/II trial evaluating its leukemia treatment emavusertib. The regulator put two partial holds in place in April of last year after a patient died from rhabdomyolysis, a complication that Curis had previously identified as a safety signal where skeletal muscle starts to break down into the blood. In August, it said some patients could be enrolled in the Phase Ia trial if they received a lower dose of 200 mg.
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