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) 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.
Syndax (Nasdaq: SNDX) announced management will participate in multiple investor conferences in November 2025, featuring fireside chats by CEO Michael A. Metzger and other executives.
Scheduled appearances: UBS Global Healthcare Conference on Nov 10, 2025 at 11:00 a.m. ET; Guggenheim Healthcare Innovation on Nov 11, 2025 at 3:00 p.m. ET; Stifel Healthcare Conference on Nov 13, 2025 at 10:00 a.m. ET; and Jefferies London Healthcare Conference on Nov 20, 2025 at 10:00 a.m. GMT / 5:00 a.m. ET.
A live webcast and limited-time replay will be available in the Investor section at www.syndax.com.
Syndax (Nasdaq: SNDX) will report third quarter 2025 financial results and provide a business update on Monday, November 3, 2025. Management will host a conference call and live audio webcast at 4:30 p.m. ET the same day.
Investors can access the live webcast and slides via the Investors & Events page on the company website or join by phone using Conference ID: Syndax3Q25 (Domestic: 800-590-8290; International: 240-690-8800). A replay will be available on the Investors site about 24 hours after the call and remain accessible for 90 days.
Syndax (NASDAQ: SNDX) announced FDA approval of Revuforj (revumenib) on October 24, 2025 for treatment of relapsed or refractory (R/R) acute myeloid leukemia with a susceptible NPM1 mutation in adults and pediatric patients one year and older with no satisfactory alternative options.
The approval expands Revuforj’s prior 2024 indication for R/R acute leukemia with a KMT2A translocation, making it the first FDA-approved menin inhibitor for multiple acute leukemia subtypes. Approval was supported by AUGMENT-101 Phase 2 data showing CR+CRh 23% (15/65), median time to response 2.8 months, and median duration of response 4.5 months. Revuforj is included in the NCCN Guidelines as a category 2A option for R/R NPM1m AML and KMT2A-rearranged acute leukemia.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced on October 1, 2025 that it granted inducement awards under its 2023 Inducement Plan to 10 new employees to purchase up to 138,900 shares of common stock. The awards are stock options that vest over four years: 25% vest on the one‑year anniversary of the vesting commencement date and the remaining shares vest monthly at 1/48th per month over the following 36 months, subject to continued service. The grants were reported under Nasdaq Listing Rule 5635(c)(4).
Syndax Pharmaceuticals (NASDAQ:SNDX) announced that its drug Revuforj® (revumenib) has been included in the NCCN Guidelines® as a category 2A treatment recommendation for relapsed or refractory NPM1 mutated acute myeloid leukemia (AML). The update follows positive results from the AUGMENT-101 trial published in Blood in 2025.
The drug maintains its category 2A recommendation for R/R acute leukemia with KMT2A rearrangement. Syndax has submitted a supplemental New Drug Application (sNDA) for revumenib with Priority Review status and a PDUFA date of October 25, 2025.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has granted inducement stock options to 11 new employees. The awards, issued under the Company's 2023 Inducement Plan, allow for the purchase of up to 167,400 shares of common stock.
The stock options feature a four-year vesting schedule, with 25% of shares vesting after one year and the remaining vesting monthly at a rate of 1/48th over the subsequent 36 months, contingent on continued employment.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on innovative cancer therapies, has announced its participation in two upcoming investor conferences in September 2025.
CEO Michael A. Metzger and the management team will present at Citi's 2025 BioPharma Back to School Conference on September 2 at 4:45 p.m. ET and the H.C. Wainwright 27th Annual Global Investment Conference on September 8 at 9:00 a.m. ET. Both presentations will be available via webcast on the company's investor relations website.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has granted inducement awards to seven new employees under its 2023 Inducement Plan. The awards consist of stock options to purchase up to 48,600 shares of common stock.
The stock options feature a four-year vesting schedule, with 25% of shares vesting after one year and the remaining 1/48th vesting monthly over the subsequent 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (NASDAQ:SNDX) reported strong Q2 2025 financial results, highlighting significant growth in its commercial portfolio. Revuforj generated $28.6M in net revenue, up 43% from Q1, while Niktimvo achieved $36.2M in net revenue in its first full quarter, contributing $9.4M in collaboration revenue to Syndax.
Key developments include FDA Priority Review for Revuforj's sNDA in R/R mNPM1 AML with a PDUFA date of October 25, 2025. The company maintains a strong financial position with $517.9M in cash and expects to reach profitability with stable operating expenses. Clinical data showed promising results, including a 48% overall response rate in R/R mNPM1 AML patients.