Welcome to our dedicated page for Syndax Pharmaceuticals news (Ticker: SNDX), a resource for investors and traders seeking the latest updates and insights on Syndax Pharmaceuticals stock.
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) is a commercial-stage biopharmaceutical company whose news flow centers on cancer drug development, regulatory milestones, and commercialization updates. The company’s announcements emphasize progress with its two FDA-approved therapies: Revuforj® (revumenib), an oral menin inhibitor for specific relapsed or refractory acute leukemias, and Niktimvo™ (axatilimab-csfr), a CSF-1 receptor-blocking antibody for chronic graft-versus-host disease after at least two prior systemic therapies.
News for SNDX often covers quarterly and annual financial results, product revenue trends for Revuforj and Niktimvo, and guidance on research and development as well as selling, general and administrative expenses. Investors can follow updates on clinical trial milestones, such as Phase 2 and Phase 3 studies of revumenib in newly diagnosed and relapsed or refractory NPM1-mutated and KMT2A-rearranged AML, and trials of axatilimab in chronic GVHD and idiopathic pulmonary fibrosis.
Press releases also highlight regulatory events, including FDA approvals and label expansions, inclusion of revumenib in clinical practice guidelines, and special designations such as Orphan Drug, Fast Track, and Breakthrough Therapy. Scientific and medical conference activity is another recurring theme, with multiple abstracts and oral presentations at meetings like the American Society of Hematology and appearances at investor conferences and healthcare forums.
In addition, Syndax issues news on collaborations and access initiatives, such as its agreement with the World Orphan Drug Alliance to launch a multi-regional Managed Access Program for Revuforj outside the United States. For investors and observers tracking SNDX, the news stream provides insight into commercial performance, pipeline evolution, partnership activity, and the company’s stated path toward profitability.
Syndax (Nasdaq: SNDX) reported preliminary, unaudited 4Q25 and full‑year 2025 results and business updates ahead of its J.P. Morgan presentation on Jan 12, 2026.
Key figures: preliminary Revuforj net revenue of $44M in 4Q25 and $125M for 2025, Revuforj net revenue up ~38% in 4Q25 vs 3Q25; preliminary Niktimvo net revenue of $56M in 4Q25 and $152M for 2025. Year‑end cash and marketable securities approx. $394M. 2026 expense outlook: R&D plus SG&A ~$400M (ex‑$50M stock comp). Several Phase 2/3 trials and access programs planned for 2026.
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.
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