FDA Grants Fast Track designation To Aptose Biosciences for HM43239 in Relapsed/Refractory AML Patients and FLT3 Mutation

Aptose Biosciences Inc. APTO announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation.

HM43239 is being investigated in an ongoing international Phase 1/2 clinical study for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).

William G. Rice, Ph.D., Chairman, President and Chief Executive Officer., said, ”HM43239, which potently inhibits all tested forms of FLT3 and the SYK and JAK driven pathways, already has delivered complete remissions in a broad diversity of relapsed or refractory AML patients in an ongoing Phase 1/2 clinical trial, including patients with prior failure of other FLT3 inhibitor agents. Fast Track designation will help facilitate the drug's development.”

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Aptose Biosciences is trading down 4 percent at $1.15 in the pre-market session.