As Agios Pharmaceuticals Inc. awaits an FDA decision on ivosidenib (AD-120) in relapsed or refractory acute myeloid leukemia (r/r AML) – the isocitrate dehydrogenase 1 mutant, or IDH1m, inhibitor is under priority review with an Aug. 21 PDUFA date – the company moved AG-348, its selective small-molecule activator of the pyruvate kinase-R (PKR) enzyme, into a second phase III trial that will lay the groundwork for another potential filing. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 80 adults with pyruvate kinase (PK) deficiency who do not receive regular blood transfusions, seeking to show that AG-348 produces sustained increase in hemoglobin (Hb) in those individuals.