Business
Syndax Pharmaceuticals Reports Fourth Quarter 2021 Financial Results and Provides Clinical and Business Update
- Enrollment remains on track for pivotal programs of SNDX-5613 and axatilimab; topline data expected starting in 1H23 - - Initiation of three new trials of
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"- Enrollment remains on track for pivotal programs of SNDX-5613 and axatilimab; topline data expected starting in 1H23 -\n - Initiation of three new trials of SNDX-5613 in NPM1 and MLLr acute leukemias, including in the first-line and maintenance settings, expected in 1H22 -\n - Company to host conference call today at 4:30 p.m. ET -\n\n\nWALTHAM, Mass., March 1, 2022 /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 fourth quarter ended December 31, 2021. In addition, the Company provided a clinical and business update.\n\"2021 was marked by substantial progress advancing our pipeline of novel cancer therapies, including the initiation of our two pivotal programs for which we expect to report topline data starting in the first half of 2023,\" said Michael A. Metzger, Chief Executive Officer. \"We believe SNDX-5613 is poised to serve as a first-to-market and best-in-class menin inhibitor for patients with genetically defined acute leukemias. With our first regulatory filing for SNDX-5613 expected in 2023, we are keenly focused on laying the groundwork for the potential commercial launch, while concurrently expanding into the frontline and maintenance settings, with three new trials expected to begin in the first half of this year.\"\nMr. Metzger continued, \"Enrollment remains on track in our global pivotal Phase 2 AGAVE-201 trial of axatilimab in chronic graft-versus-host disease (cGVHD), with topline data expected in the first half of 2023 and a potential Biologic License Application (BLA) filing in 2023. Beyond cGVHD, we are also working to unlock axatilimab's full potential in additional fibrotic diseases where the monocyte-macrophage lineage plays a vital role, with commencement of a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) expected in the fourth quarter of this year.\"\nRecent Pipeline Progress and Anticipated Milestones\nSNDX-5613\nDuring an oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021, the Company reported positive data demonstrating continued robust clinical activity with durable responses in the Phase 1 portion of the AUGMENT-101 trial of SNDX-5613, the Company's ...