Business
Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Business Update
– Topline data from AUGMENT-101 KMT2Ar patients expected in the third quarter of 2023 – –Topline data from the pivotal AGAVE-201 trial on track for mid-2023 –
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Topline data from AUGMENT-101 KMT2Ar patients expected in the third quarter of 2023 –\n–Topline data from the pivotal AGAVE-201 trial on track for mid-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., Feb. 28, 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 fourth quarter and full year ended December 31, 2022 and provided a business update.\n\"With two pivotal data readouts expected later this year and potential regulatory filings to follow shortly thereafter, we expect 2023 will be an extraordinary year for Syndax,\" said Michael A. Metzger, Chief Executive Officer. \"The fourth quarter was marked by significant progress on the clinical, regulatory and operational fronts and we expect this positive momentum to continue in 2023. We had a strong presence at the American Society of Hematology (ASH) Annual Meeting where we presented positive revumenib results from the Phase 1 portion of the AUGMENT-101 trial and the axatilimab Phase 1/2 trial data were published in the Journal of Clinical Oncology. These data further support the potential for both our pipeline agents to be first- and best-in-class therapies that could meaningfully change treatment paradigms.\"\n\"For revumenib, we are on track to begin reporting topline data from the AUGMENT-101 pivotal trial in the third quarter of this year, with the first data expected to be in patients with KMT2A rearranged (KMT2Ar) acute leukemia and expect to file a New Drug Application (NDA) by year-end 2023. For axatilimab, we also remain on track to report topline results from our pivotal AGAVE-201 trial in chronic graft versus host disease (cGVHD) in mid-2023, with a Biologics License Application (BLA) filing expected to follow by year-end 2023. We look forward to providing updates on all of our progress as we continue to strive toward our mission of realizing a future in which people with cancer live longer and better than ever before.\"\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: patie...