Business
Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
– $7.7 million in Revuforj® (revumenib) net product revenue in initial five weeks of launch – – Launched Niktimvo™ (axatilimab-csfr) in the U.S. in late
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– $7.7 million in Revuforj® (revumenib) net product revenue in initial five weeks of launch – – Launched Niktimvo™ (axatilimab-csfr) in the U.S. in late January, in partnership with Incyte – – sNDA filing for revumenib in R/R mNPM1 AML expected in 2Q25 based on positive pivotal data from AUGMENT-101 trial – – $692.4 million in cash, cash equivalents and investments expected to fund the company to profitability – – Company to host a conference call today at 8:00 a.m. ET – NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today reported its financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “We are off to a strong start with the U.S. launch of Revuforj and are very encouraged by the early patient demand, breadth of prescribing, and coverage from payers. Our early results are consistent with the high unmet need in R/R KMT2A-rearranged acute leukemia and reflect strong execution across our entire organization,” said Michael A. Metzger, Chief Executive Officer. “With two first-in-class medicines on the market that address major unmet needs and a robust development strategy underway for expansion, Syndax is well-positioned to unlock the multi-billion-dollar potential of both medicines.” Recent Business Highlights and Anticipated Milestones Revuforj® (revumenib) Achieved $7.7 million in Revuforj net product revenue in the fourth quarter of 2024, the first partial quarter (initial five weeks) of the U.S. launch. The Company estimates that approximately one-third of the net revenue represents inventory at specialty pharmacies and specialty distributors and the remainder represents patient demand. Revuforj was launched in the U.S. in late November 2024, following the FDA’s approval on November 15, 2024 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 (KMT2Ar).1Announced that the primary endpoint was met in ...