James Dentzer, Curis CEO
'Rapid' path for Curis' lead leukemia drug hits roadblock with partial clinical hold after patient death
A patient has died in a Phase I/IIa trial of Curis’ lead drug after experiencing rhabdomyolysis, “among several conditions.” As a result, FDA has slapped a partial clinical hold on the study.
The hold could throw the biotech’s plans for a potential “rapid regulatory path” of the drug into question. Just six weeks ago, Curis said it expected to meet with the FDA to discuss the registrational route for emavusertib as a monotherapy in the first half of this year.
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