Business
Syndax Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Clinical and Business Update
- Intermediate doses selected for Phase 2 portion of AUGMENT-101 trial of SNDX-5613 in patients with genetically-defined acute leukemias; updated results from
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Intermediate doses selected for Phase 2 portion of AUGMENT-101 trial of SNDX-5613 in patients with genetically-defined acute leukemias; updated results from Phase 1 portion anticipated in 4Q21 -\n - Syndax initiating frontline combination of SNDX-5613 with venetoclax and azacitidine in the Beat® AML Master Clinical Trial -\n - Enrollment ongoing in global pivotal AGAVE-201 trial of axatilimab in cGVHD; updated results from Phase 1/2 trial anticipated in 4Q21 -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., Aug. 9, 2021 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (\"Syndax,\" the \"Company\" or \"we\") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the second quarter ended June 30, 2021. In addition, the Company provided a clinical and business update.\n\"The second quarter of 2021 was marked by significant progress advancing our pipeline of innovative therapeutics, and we are pleased to share that we have selected a go-forward dose for the pivotal Phase 2 portion of AUGMENT-101 based on favorable findings from the intermediate dose cohort,\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"Enrollment in the trial continues, with recently enrolled patients expected to count towards the Phase 2 expansion portion, subject to endorsement of the Phase 2 dose by the U.S. Food and Drug Administration (FDA). We are also excited to announce an important step in our plans to expand development of SNDX-5613 into earlier lines of therapy with the initiation of the first frontline combination trial of a menin inhibitor in the Leukemia & Lymphoma Society's Beat® AML Master Clinical Trial.\"\n\"Beyond SNDX-5613, enrollment remains on track in the ongoing global pivotal AGAVE-201 trial of axatilimab in patients with chronic graft versus host disease (cGVHD), and we continue to expect topline data from the trial in 2023. In addition, as previously announced, we anticipate sharing updated results from the recently completed Phase 1/2 trial of axatilimab in cGVHD later this year and remain committed to unlocking the full potential of axatilimab in the growing number of cGVHD patients lacking effective interventions.\"\nRecent Progress and Anticipated Milestones\nSNDX-5613 \nIn May 2021,...