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Syndax Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
SNDXSyndax(SNDX) GlobeNewswire·2025-03-03 12:01

Core Insights - Syndax Pharmaceuticals reported a strong start with the U.S. launch of Revuforj, achieving 7.7millioninnetproductrevenueintheinitialfiveweeks,indicatinghighpatientdemandandbroadprescribing[1][4][10]−ThecompanylaunchedNiktimvo™intheU.S.inlateJanuary2025,inpartnershipwithIncyte,expandingitsproductofferingsintheoncologyspace[1][6]−SyndaxexpectstofileasupplementalNDAforrevumenibinrelapsed/refractorymNPM1AMLinQ22025,basedonpositivedatafromtheAUGMENT−101trial[1][4][19]−Thecompanyhas7.7 million in net product revenue in the initial five weeks, indicating high patient demand and broad prescribing [1][4][10] - The company launched Niktimvo™ in the U.S. in late January 2025, in partnership with Incyte, expanding its product offerings in the oncology space [1][6] - Syndax expects to file a supplemental NDA for revumenib in relapsed/refractory mNPM1 AML in Q2 2025, based on positive data from the AUGMENT-101 trial [1][4][19] - The company has 692.4 million in cash and investments, which is expected to fund operations until profitability [1][10][15] Business Highlights - Revuforj (revumenib) generated 7.7millioninnetproductrevenueduringitsfirstpartialquarteroflaunch,withone−thirdattributedtoinventoryatspecialtypharmacies[4][10]−RevumenibwasincludedintheNCCNClinicalPracticeGuidelinesforacutemyeloidleukemiaandacutelymphoblasticleukemiaasacategory2Arecommendation[4]−TheprimaryendpointwasmetintheAUGMENT−101trial,with267.7 million in net product revenue during its first partial quarter of launch, with one-third attributed to inventory at specialty pharmacies [4][10] - Revumenib was included in the NCCN Clinical Practice Guidelines for acute myeloid leukemia and acute lymphoblastic leukemia as a category 2A recommendation [4] - The primary endpoint was met in the AUGMENT-101 trial, with 26% of patients achieving complete remission or partial hematological recovery [4][19] - Ongoing trials for revumenib include combinations with venetoclax and azacitidine, showing promising results in various patient populations [8][19] Financial Performance - For Q4 2024, research and development expenses increased to 65.5 million from 55.1millionyear−over−year,drivenbyclinicalandpre−commercialmanufacturingcosts[11]−Selling,general,andadministrativeexpensesroseto55.1 million year-over-year, driven by clinical and pre-commercial manufacturing costs [11] - Selling, general, and administrative expenses rose to 37.7 million in Q4 2024, reflecting increased costs related to the commercial launch of Revuforj [12] - The net loss attributable to common stockholders for Q4 2024 was 94.2million,comparedtoalossof94.2 million, compared to a loss of 72.5 million in the same period the previous year [13] - The company expects R&D expenses for Q1 2025 to be between 65millionand65 million and 70 million, with total operating expenses projected to be 105millionto105 million to 110 million [14] Future Outlook - Syndax plans to initiate multiple trials for revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025 [8] - The company is also evaluating revumenib in patients with relapsed metastatic colorectal cancer [8] - The anticipated filing for revumenib in R/R mNPM1 AML and ongoing trials position Syndax to capitalize on significant market opportunities in oncology [1][4][19]