2023-07-06 08:27:17 ET
Curis, Inc. ( NASDAQ: CRIS ) announced Thursday that the FDA removed the partial clinical hold placed on the company’s Phase 1/2 TakeAim Leukemia trial for lead candidate emavusertib.
The trial is targeted at patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Curis ( CRIS ) added that its investigators selected 300 mg BID dosing for emavusertib as the recommended phase 2 dose (RP2D) in the monotherapy phase.
However, the initial investor reaction to the announcement appeared negative, with shares of the Lexington, Massachusetts-based biotech trading ~14% lower in the pre-market.
The FDA placed partial clinical holds on the company’s TakeAim Leukemia trial and Phase 1/2 TakeAim Lymphoma trial following a serious adverse event found in the TakeAim Leukemia trial.
In August 2022, the FDA lifted the partial hold on the TakeAim Lymphoma trial and allowed the company to resume additional enrollments in the monotherapy dose-finding phase of the TakeAim Leukemia trial.
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Curis says FDA lifted partial clinical hold on leukemia trial