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 Pharmaceuticals (Nasdaq: SNDX) announced that Revuforj (revumenib) was named to TIME’s Best Inventions of 2026 in Medical and Healthcare.
Revuforj is FDA approved for adults and children one year and older with relapsed or refractory acute leukemia with a KMT2A translocation, or acute myeloid leukemia with a susceptible NPM1 mutation and no satisfactory alternative treatment options. TIME evaluated contenders on originality, efficacy, ambition and impact.
Syndax Pharmaceuticals (SNDX) announced that its MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmonary fibrosis failed its primary endpoint. The endpoint measured the annualized decline in forced vital capacity (FVC), a measure of how much air a person can forcibly exhale. Syndax does not plan further development of axatilimab in this lung disease.
The 145-patient, 26-week trial compared axatilimab with placebo. The annualized 52-week FVC rate was derived from measurements collected over 26 weeks. Safety and tolerability were comparable to placebo, with no new safety signals or treatment-related fatal adverse events in either arm.
The results do not affect ongoing trials in other potential indications. Axatilimab remains in frontline combination trials for chronic graft-versus-host disease (cGVHD), including combinations with ruxolitinib and steroids. Syndax expects cGVHD trial results later in 2026 and early 2028.
Syndax Pharmaceuticals (SNDX) granted inducement stock options covering up to 213,300 common shares on October 1, 2026, to new employees.
The awards went to nine employees under the company's 2023 Inducement Plan. Options vest over four years: 25% on the first anniversary of the vesting commencement date, then 1/48th monthly over 36 months. Vesting requires continued service with Syndax through each applicable vesting date.
Syndax Pharmaceuticals (SNDX) granted inducement stock options for up to 175,000 shares of common stock to nineteen new employees on September 1, 2026, under its 2023 Inducement Plan.
The options vest over four years, with 25% vesting after one year and the remaining 75% vesting in equal monthly installments over the following 36 months, contingent on continued service.
Syndax Pharmaceuticals (Nasdaq:SNDX) will participate in two September 2026 investor conferences in New York. CEO Michael A. Metzger and the management team are scheduled for fireside chats at the Citi 2026 Biopharma Back to School Conference on September 10 at 8:40 a.m. ET, and the H.C. Wainwright 28th Annual Global Investment Conference on September 15 at 10:00 a.m. ET. Live webcasts and limited-time replays will be accessible via the Investor section of Syndax’s website.
Syndax Pharmaceuticals (Nasdaq: SNDX) reported that on August 1, 2026, it granted stock option inducement awards covering up to 59,250 shares of common stock to five new employees under its 2023 Inducement Plan. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following 36 months, contingent on continued service.
Syndax (Nasdaq: SNDX) reported second quarter 2026 total revenue of $72.8 million, up 92% year over year, driven by Revuforj net revenue of $54.7 million (+91% YoY) and Niktimvo collaboration revenue of $18.1 million based on $60.3 million Niktimvo net sales.
Second quarter R&D expenses rose to $68.0 million, while SG&A declined to $41.5 million. For the first half of 2026, Syndax recorded a net loss attributable to common stockholders of $49.4 million, or $0.55 per share, versus $71.8 million, or $0.83 per share, a year earlier. Cash, cash equivalents and investments totaled $575.1 million as of June 30, 2026.
The company expanded its pipeline with SNDX-4321, a mutant‑selective allosteric EGFR inhibitor for NSCLC, and SNDX-62122, a next‑generation menin inhibitor for myelofibrosis, and outlined multiple ongoing and planned Phase 1–3 trials for Revuforj and Niktimvo. Syndax continues to expect 2026 operating expenses (R&D plus SG&A) of about $400 million, excluding around $50 million of non‑cash stock compensation, and believes its cash and anticipated revenues will enable it to reach profitability.
Syndax Pharmaceuticals (Nasdaq: SNDX) will report its second quarter 2026 financial results and provide a business update on Tuesday, August 4, 2026. Management will host a conference call and live audio webcast at 4:30 p.m. ET, accessible via the Events & Presentations page in the Investors section of its website or by domestic and international dial-in numbers.
A live webcast link (https://sndx-2q26.open-exchange.net/) and Conference ID Syndax2Q26 are provided. According to Syndax, a replay will be available on its website approximately 24 hours after the call and remain accessible for 90 days.
Syndax Pharmaceuticals (Nasdaq: SNDX) is hosting an R&D Event on July 14, 2026, to showcase its late-stage programs and unveil new pipeline assets, including SNDX-4321 and SNDX-62122.
SNDX-4321 is a novel, mutant-selective, allosteric EGFR inhibitor licensed worldwide for development and commercialization in EGFR-mutated NSCLC, with an IND submission targeted by year-end 2026 and a Phase 1 trial planned for 2027. SNDX-62122, the first candidate from the company’s internally developed, wholly owned next-generation menin inhibitor library, is being advanced for myelofibrosis, with an IND and Phase 1 trial expected in 2027, informed by a revumenib MF proof-of-principle study starting in 4Q26. The event will also review ongoing late-stage programs for Revuforj (revumenib) and Niktimvo (axatilimab-csfr), including a Phase 2 axatilimab trial in IPF expected to deliver topline data in 4Q26.
Syndax Pharmaceuticals (Nasdaq:SNDX) granted inducement stock options to eight new employees on July 1, 2026 under its 2023 Inducement Plan. The awards cover up to 250,700 shares of common stock and vest over four years, subject to continued employment-based service conditions.