Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for revumenib, the Company's first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia. The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process, which historically has led to earlier approvals.

The NDA submission is supported by positive data from the pivotal AUGMENT-101 trial of revumenib in adult and pediatric patients with KMT2Ar acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL). Positive topline results from the Phase 2 AUGMENT-101 trial in R/R KMT2Ar acute myELoid leukemia showing the trial met its primary endpoint were presented at the 65th American Society of Hematology Annual Meeting and data from the Phase 1 portion of AUGMENT-101 in acute leukemia was published in Nature. Revumenib was granted Orphan Drug Designation by the FDA and European Commission for the treatment of patients with AML and Fast Track designation by the FDA for the treatment of adult and adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation.

Revumenib was granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment the treatment of adult and pediatric patients with R-R acute leukemias Harboring a KMT2Aangeangement or NPM1 mutations. Revumenib was granted breakthrough Therapy Designation (BT D) by the FDA for the treated of adult and pediatric patients with K MT2A acute myeloid leukemia (AML) and acute lymphoidukemia (ALL). Positive toplines results from the Phase 2 AugMENT-101 trial in R-R KMT2Ar acute leukemia showing the trial met its Primary endpoint were presented at the 65% American Society of Hematology annual Meeting and data from the Phase1 portion of AUGMENT- 101 in acute leukemia was published in nature.

Revumenib was grantedOrphan Drug Designation by theFDA and European Commission for the treatment the treatment of patients with AM L and Fast Track designation by theFDA for the treatment of adult andiatric patients with R/R acute Leukemias harboring aKMT2A rearrangements or NPM1 mutation.