Business
Syndax Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update
– Announced positive topline results from the pivotal AGAVE-201 trial of axatilimab in cGVHD – – Topline data from the pivotal AUGMENT-101 trial of revumenib
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Announced positive topline results from the pivotal AGAVE-201 trial of axatilimab in cGVHD –\n– Topline data from the pivotal AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia on track for the third quarter of 2023 –\n– Two U.S. registrational filings expected by the end of 2023 –\n– Company to host conference call today at 4:30 p.m. ET –\nWALTHAM, Mass., Aug. 3, 2023 /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, 2023, and provided a business update.\n\"On the heels of recently reported positive data from our pivotal AGAVE-201 trial of axatilimab in chronic graft-versus-host disease, we remain on track to achieve several additional important milestones for both of our programs in what is proving to be a transformational year for Syndax,\" said Michael A. Metzger, Chief Executive Officer. \"The AGAVE-201 data underscore axatilimab's ability to provide meaningful benefit to patients suffering from cGVHD, and we are working with our partners at Incyte to potentially submit a BLA filing by the end of 2023.\"\nMr. Metzger added, \"Additionally, we remain on track to report topline pivotal data from the KMT2Ar cohorts of the Phase 2 AUGMENT-101 trial of revumenib for acute leukemias this quarter, followed by a potential NDA filing by the end of this year. We continue to be focused on executing our robust clinical development plans for both axatilimab and revumenib to fully realize their potential as best-in-class medicines.\"\nRecent Pipeline Progress and Anticipated Milestones\nRevumenib \nThe pivotal Phase 2 portion of AUGMENT-101 is enrolling relapsed/refractory (R/R) patients across distinct trial populations: patients with nucleophosmin mutant (mNPM1) acute myeloid leukemia (AML), patients with KMT2Ar AML, and patients with KMT2Ar acute lymphocytic leukemia (ALL). The Company expects to share topline data from a pooled analysis of the KMT2Ar cohorts in the third quarter of 2023 and submit a New Drug Application (NDA) filing by the end of 2023. The Company also expects to complete enrollment of the mNPM1 AML cohort by year-end 2023.The Company has several trials of revumenib ongoing across the treatment landscape in mNPM1 and KMT2Ar acute leukemias th...