Source disclosure: February 25, 2026, 15:30 JST
Delta-Fly Pharma,Inc. [4598.T]
TOKYO, Feb 25 (Pulse News Wire) – Delta-fly Pharma,inc. (4598.T) announced today that its phase III trial of DFP101 for relapsed/refractory acute myeloid leukemia (R/R AML) was terminated after an interim analysis failed to meet the primary endpoint of superiority.
However, the Data Safety Monitoring Board noted that the efficacy rate (CR+CRi+CRp+PR) showed higher values in the DFP101 group compared to the control group, though there was no significant difference. Additionally, patients who had poor responses to conventional treatments demonstrated improved outcomes with DFP101. The U.S.
Food and Drug Administration (FDA) has designated DFP101 as an orphan drug for treating rare diseases. Due to its low-cost nature as a small molecule compound, approval through a New Drug Application (NDA) could offer therapeutic and economic benefits for R/R AML patients. Delta-Fly Pharma plans to negotiate conditional NDA approval with the FDA moving forward.
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