08:17 AM EDT, 04/22/2024 (MT Newswires) -- Kura Oncology ( KURA ) said Monday the US Food and Drug Administration has granted Breakthrough Therapy Designation for its potential leukemia drug ziftomenib.
The FDA granted the designation based on data from the company's clinical trial in patients who have relapsed/refractory NPM1-mutant acute myeloid leukemia, Kura said.
The company said the registration-directed trial of ziftomenib is slated for completion by the middle of this year.
Kura shares rose 3.3% in recent Monday premarket activity.