Business
Syndax Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Clinical and Business Update
- Initiated pivotal Phase 2 portion of SNDX-5613 AUGMENT-101 trial in patients with NPM1 and MLLr acute leukemias - - Entered global collaboration with Incyte
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Initiated pivotal Phase 2 portion of SNDX-5613 AUGMENT-101 trial in patients with NPM1 and MLLr acute leukemias -\n - Entered global collaboration with Incyte to develop and commercialize axatilimab for cGVHD and other fibrotic diseases -\n - Updated data from SNDX-5613 and axatilimab clinical programs to be presented during oral sessions at 63rd ASH Annual Meeting -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., Nov. 15, 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 third quarter ended September 30, 2021. In addition, the Company provided a clinical and business update.\n\"We are thrilled to announce that the pivotal Phase 2 portion of AUGMENT-101, examining SNDX-5613 across three distinct patient populations, is open and enrolling following a productive meeting with the U.S. Food and Drug Administration (FDA),\" said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. \"Supported by a growing body of data, we firmly believe that SNDX-5613 is ideally positioned to be first to market and serve as a meaningful intervention for patients with mutant nucleophosmin (NPM1c) and mixed lineage leukemia rearranged (MLLr) acute leukemias who are deeply in need of effective therapies. We look forward to presenting updated data from the Phase 1 portion of the AUGMENT-101 trial, including updated durability of CR/CRh responses, during an oral session at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting.\"\n\"We were also pleased to recently announce our partnership with Incyte for the development and commercialization of axatilimab. This agreement represents a key step forward in our strategy to expand and maximize the program across multiple lines of treatment in chronic graft-versus-host disease (cGVHD) as well as additional fibrotic diseases, such as idiopathic pulmonary fibrosis (IPF), where the monocyte-macrophage lineage plays a vital role. As we continue to execute on advancing the program, we look forward to sharing updated data from our Phase 1/2 trial of axatilimab in cGVHD during an oral session at the ASH Annual Meeting next month.\"\nRecent Pipeline Progress and Ant...