Business
Syndax Reports Second Quarter 2024 Financial Results and Provides Clinical and Business Update
– Axatilimab BLA in refractory chronic GVHD is under Priority Review; PDUFA action date of August 28, 2024 – – Revumenib NDA in R/R KMT2Ar acute leukemia is
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Axatilimab BLA in refractory chronic GVHD is under Priority Review; PDUFA action date of August 28, 2024 –\n– Revumenib NDA in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 –\n– Pivotal AUGMENT-101 topline data from the mNPM1 AML cohort expected in 4Q24; potential sNDA filing in 1H25 –\n– Company to host a conference call today at 4:30 p.m. ET –\nWALTHAM, Mass., Aug. 1, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended June 30, 2024, and provided a business update.\n\n\"This is an exciting time for Syndax as we transition to a commercial stage company,\" said Michael A. Metzger, Chief Executive Officer. \"We've made significant progress advancing our pipeline this quarter, including the presentation of updated revumenib combination data from the BEAT AML and AUGMENT-102 trials and additional axatilimab data from the AGAVE-201 trial at EHA. We are excited to continue building on this momentum as we look ahead to the approval of both first-in-class assets and sharing pivotal AUGMENT-101 data in mNPM1 AML this year.\"\nRecent Pipeline Progress and Anticipated Milestones\nRevumenib \nThe New Drug Application (NDA) for revumenib, a highly selective menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia was granted Priority Review and is being reviewed under the U.S. FDA's Real-Time Oncology Review (RTOR) Program. On July 29, 2024, the Company announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) target action date for the revumenib NDA from September 26, 2024 to December 26, 2024 to provide FDA additional time to conduct a full review of supplemental information provided by the Company in response to the FDA's requests. The Company expects to report topline data from the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) in the fourth quarter of 2024. Positive data could support a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025.Multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemias are ongoing acros...