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Syndax Highlights Recent Accomplishments and Anticipated 2025 Milestones at the 43rd Annual J.P. Morgan Healthcare Conference
– Launched Revuforj® (revumenib) for treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older – –
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Launched Revuforj® (revumenib) for treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older –\n– Revumenib added to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)for AML and ALL –\n– Niktimvo™ (axatilimab-csfr) approved by U.S. FDA for treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg –\n– sNDA filing for revumenib in R/R mNPM1 AML expected in 1H25 based on positive pivotal data from AUGMENT-101 trial –\nWALTHAM, Mass., Jan. 13, 2025 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 10:30 a.m. PT/1:30 p.m. ET. Ahead of the presentation, Syndax highlighted its recent accomplishments and anticipated 2025 milestones.\n\n\"Building on a transformative 2024 with the FDA approvals of Revuforj® and Niktimvo™, we are focused on executing two outstanding U.S. launches for these first-in-class, practice-changing medicines,\" said Michael A. Metzger, Chief Executive Officer. \"Syndax is well-positioned for continued success and long-term growth with two approved drugs launching into multi-billion-dollar markets, a clear strategy to expand into additional indications, and a strong cash position expected to fund operations through profitability.\"\n2024 Key Accomplishments \nRevumenib:\nLaunched Revuforj (revumenib), the first and only U.S. Food and Drug Administration (FDA) approved menin inhibitor, in late November 2024. Revuforj was approved by the FDA under the Agency's Real-Time Oncology Review (RTOR) program for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.Revumenib was added to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement.1Announced that the primary endpoint was met in the protocol-defined efficacy population of 64 adults with R/R mNPM1 AML in the Phase 2 cohort of the AUGMENT-101 trial of revumenib.Reported additional positive results from a post-hoc efficacy analysis of all 77 R/R mNPM1 AML patients...