Business
Syndax Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Clinical and Business Update
– Topline data from revumenib (SNDX-5613) and axatilimab pivotal programs expected starting in 1H23; Company remains on track for two FDA filings in 2023 – –
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Topline data from revumenib (SNDX-5613) and axatilimab pivotal programs expected starting in 1H23; Company remains on track for two FDA filings in 2023 –\n– BEAT-AML and AUGMENT-102 trials assessing revumenib (SNDX-5613) in combination with venetoclax-azacitidine for newly diagnosed patients and in combination with chemotherapy for R/R patients both underway; topline data expected starting in 1H23 –\n– Axatilimab granted Fast Track by U.S. FDA for the treatment of cGVHD after failure of two or more lines of systemic therapy –\n– Company to host conference call today at 4:30 p.m. ET –\nWALTHAM, Mass., May 9, 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 first quarter ended March 31, 2022. In addition, the Company provided a clinical and business update.\n\"Throughout the first quarter, we continued to realize significant progress advancing 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 firmly believe revumenib (SNDX-5613) is positioned to serve as a first-to-market and best-in-class menin inhibitor for patients with NPM1 and MLLr acute leukemias. We have also begun exploring its activity beyond use as a monotherapy agent through initiation of two new trials, including in combination with venetoclax-azacitidine for use as a frontline treatment, and in combination with chemotherapy for relapsed/refractory (R/R) disease. Beyond acute leukemias, we intend to assess revumenib's (SNDX-5613) potential in additional areas where menin inhibition could have a strong therapeutic benefit, and we look forward to commencing a proof-of-concept clinical trial in patients with advanced colorectal cancer (CRC), a highly underserved area lacking effective therapeutic options, in the fourth quarter of the year.\"\n\"Additionally, enrollment continues in the ongoing 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. Supported by recent receipt of Fast Track Designation (F...