Business
Syndax Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update
– Topline data from the pivotal AGAVE-201 trial of axatilimab in cGVHD on track for mid-2023 – – Topline data from the pivotal AUGMENT-101 trial of revumenib
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Topline data from the pivotal AGAVE-201 trial of axatilimab in cGVHD on track for mid-2023 –\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., May 8, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the quarter ended March 31, 2023 and provided a business update.\n\"Syndax is at an important inflection point with pivotal data readouts and subsequent U.S. registrational filings from each of our two potential first- and best-in-class product candidates expected by year-end,\" said Michael A. Metzger, Chief Executive Officer. \"As we continue to advance our mission to realize a future in which people with cancer live longer and better than ever before, we look forward to reporting topline data from our AGAVE-201 pivotal trial of axatilimab in chronic graft versus host disease (cGVHD) in mid-2023 as well as topline data from our AUGMENT-101 pivotal trial in patients with KMT2A-rearranged (KMT2Ar) acute leukemia in the third quarter of this year.\" \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 KMT2Ar acute myeloid leukemia (AML), patients with KMT2Ar acute lymphocytic leukemia (ALL) and patients with nucleophosmin mutant (mNPM1) AML. The Company plans to pool data from the AUGMENT-101 cohorts enrolling adult and pediatric patients with R/R KMT2Ar AML and R/R KMT2Ar ALL to file a single New Drug Application (NDA) for the treatment of adult and pediatric KMT2Ar acute leukemia. The Company expects to share topline data from the KMT2Ar pooled analysis in the third quarter of 2023 and submit an NDA filing by the end of 2023. The Company also expects to complete enrollment of the NPM1 AML cohort in the second half of 2023.The Company has obtained U.S. Food and Drug Administration (FDA) agreement on a recommended Phase 2 dose (RP2D) of 276 mg of revumenib every 12 hours for patients not receiving a strong CYP3A...