(RTTNews) - Curis, Inc. (CRIS) announced the FDA has placed a partial clinical hold on the company's TakeAim Leukemia phase 1/2a study of Emavusertib. With the partial hold, the FDA is requesting additional data from the study, including data related to the death of a R/R AML patient. Also, the FDA is requesting safety, efficacy, and other data.
Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical hold is resolved and the related impact on the trial can be determined.
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