Syndax Pharmaceuticals reports developments as a commercial-stage biopharmaceutical company advancing cancer therapies. Company updates center on Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 receptor.
Recurring news includes quarterly financial results, product revenue for Revuforj and Niktimvo, collaboration revenue from Niktimvo commercialization with Incyte, clinical data presentations in acute leukemia, chronic graft-versus-host disease and related indications, FDA-related product updates, investor conference activity and inducement equity grants under Nasdaq listing rules.
Syndax (Nasdaq: SNDX) and the World Orphan Drug Alliance announced a multi-regional Managed Access Program to expand patient access to Revuforj (revumenib) outside the U.S. The program will operate where local rules permit and funding is secured and launches in parts of Eurasia, Central and Southeast Europe, Israel, the Middle East and Turkey, Latin America, and Africa. WODA will administer named-patient supply through its network and the program will follow local regulatory and ethical frameworks. U.S. FDA approvals for Revuforj in specified relapsed/refractory KMT2A‑translocated and NPM1‑mutated acute leukemias are noted. Physicians should contact medinfo@syndax.com for details; patients must contact their physician.
Syndax (Nasdaq: SNDX) announced that Chief Executive Officer Michael A. Metzger will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:00 p.m. PT / 6:00 p.m. ET. A live webcast will be available in the company's Investor section at www.syndax.com, and a replay will be accessible for a limited time.
Syndax (Nasdaq: SNDX) announced that Revuforj (revumenib) was named Best New Drug at the Scrip Awards 2025.
Revuforj is a first-in-class menin inhibitor that received FDA approval in November 2024 for relapsed or refractory acute leukemia with a KMT2A translocation in patients one year and older, and a second FDA approval in October 2025 for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in patients one year and older who have no satisfactory alternative treatment options.
The award recognizes perceived therapeutic advance and follows the recent regulatory expansion, which company leadership described as validation of its menin-inhibition program and patient focus.
Syndax (NASDAQ: SNDX) presented 12 Revuforj (revumenib) abstracts at ASH 2025 covering real-world, post‑HSCT maintenance, and combination trials in NPM1m, KMT2Ar and NUP98r acute leukemias.
Key disclosed results: real‑world ORR 77% (10/13) and 75% MRD negativity; pediatric post‑HSCT maintenance cohort: 100% alive and 90% relapse‑free at median 19 months; Phase 2 SAVE (revumenib+venetoclax+HMA) in newly diagnosed unfit patients: ORR 86% (18/21), CR 76% (16/21), 100% MRD negativity among responders; Phase 1 with intensive chemo: ORR 96% (25/26), CRc 92% (24/26), MRD‑negative CR 86% (12/14).
Syndax Pharmaceuticals (Nasdaq: SNDX) granted inducement awards on December 1, 2025 to a newly hired employee under its 2023 Inducement Plan.
The awards permit purchase of up to 15,500 shares of common stock. Options vest over a four-year schedule: 25% of the shares vest on the one-year anniversary of the vesting commencement date, then 1/48th of the shares vest monthly for the remaining 36 months, subject to continued service.
Syndax (Nasdaq: SNDX) announced that CEO Michael A. Metzger will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Thursday, December 4, 2025 at 11:15 a.m. ET.
A live webcast will be available in the company’s Investor section at www.syndax.com, and a replay will be posted for a limited time.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced inducement equity awards on November 1, 2025, granting options to purchase up to 143,500 shares of common stock to four new employees under its 2023 Inducement Plan.
The options vest over four years: 25% at the one-year anniversary of the vesting commencement date and 1/48th monthly thereafter for the remaining 36 months, subject to continued service through each vesting date.
Syndax (Nasdaq: SNDX) reported $45.9M total revenue for 3Q25, including $32.0M Revuforj net revenue and $13.9M collaboration revenue from Niktimvo. Revuforj prescriptions rose ~25% QoQ (~850 scripts) and Revuforj received FDA approval on Oct 24, 2025 and NCCN category 2A listing for R/R NPM1m AML. Incyte reported $45.8M Niktimvo net sales; Syndax recorded 50% product contribution. Cash, cash equivalents and investments were $456.1M, which the company expects will fund it to profitability. Reported 3Q25 net loss was $60.7M. Conference call held Nov 3, 2025.
Syndax Pharmaceuticals (Nasdaq: SNDX) will host an in-person investor event with a live webcast on Monday, December 8, 2025 at 7:00 a.m. ET during the 67th American Society of Hematology (ASH) Annual Meeting.
Company management and multiple key opinion leaders will discuss data updates from the Revuforj (revumenib) and Niktimvo (axatilimab-csfr) programs. A live webcast and a replay will be available on the Investor section of the company website at www.syndax.com for a limited time.
Syndax (Nasdaq: SNDX) announced that 23 abstracts, including 6 oral presentations, featuring Revuforj (revumenib) and Niktimvo (axatilimab) data were accepted for presentation at the ASH Annual Meeting, Dec 6-9, 2025 in Orlando.
Revumenib abstracts cover frontline and relapsed/refractory acute leukemia, combination regimens (venetoclax + decitabine/cedazuridine; intensive chemo; gilteritinib), real-world experience, and post-HSCT maintenance. Axatilimab abstracts address dosing feasibility, long-term therapy in R/R chronic GVHD, combination with ruxolitinib in newly diagnosed chronic GVHD, biomarker/pharmacodynamic analyses, and a Phase 3 trial in initial therapy.
The company will host an in-person investor event with a live webcast on Dec 8, 2025 at 7:00 a.m. ET.