Axatilimab displayed similar efficacy regardless of the number of prior lines of therapy in chronic graft-versus-host disease.

– Total revenue of $73 million in 2Q26, a 92% year-over-year increase – – Revuforj ® (revumenib) net revenue of $54.7 million in 2Q26, a 91% year-over-year increase – – Niktimvo™ (axatilimab-csfr) net revenue of $60.3 million in 2Q26, a 67% year-over-year increase, resulting in Syndax collaboration

MONTREAL, Aug. 04, 2025 (GLOBE NEWSWIRE) — Knight Therapeutics Inc., (TSX: GUD) (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced tod…

The Therapeutic Goods Administration in Australia has granted approval to NIKTIMVO (axatilimab) for chronic graft-versus-host disease. This first-in-class therapy marks a significant advancement in treatment options.

Researchers sought to determine whether combining axatilimab and ruxolitinib is a safe strategy among patients with newly diagnosed chronic GVHD.

– Total revenue of $64.9 million in 1Q26, a 224% year-over-year increase – – Revuforj ® (revumenib) net revenue of $48.9 million in 1Q26, highlighting leadership in menin inhibition and increasing uptake in R/R NPM1m AML – – Niktimvo™ (axatilimab-csfr) net revenue of $55.1 million in 1Q26,

Syndax (NASDAQ: SNDX) reported Q4 2025 revenue $68.7M and FY2025 revenue $172.4M, driven by Revuforj net sales of $44.2M in Q4 ($124.8M FY2025) and Niktimvo net sales of $56.0M in Q4 ($151.6M FY2025).The company had $394.1M in cash and equivalents at year-end, completed Phase 2 IPF enrollment for axatilimab, and expects 2026 R&D plus SG&A of ~$400M while targeting profitability from product and collaboration revenue.

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.

Specialised Therapeutics (ST) has expanded its partnership with Incyte to distribute two additional oncology therapies - axatilimab (Niktimvo) and retifanlimab (Zynyz) - in Australia, New Zealand, and Singapore. These medicines join the existing portfolio of Minjuvi and Pemazyre. Axatilimab, approved by FDA in August 2024, treats chronic graft-versus-host disease in patients who've had at least two prior treatments. Retifanlimab is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest MCC incidence globally. Under the agreement, Incyte will handle development and manufacturing, while ST will manage regulatory affairs, distribution, and local marketing. ST plans to submit both drugs for regulatory and reimbursement approval in 2025.

Syndax Pharmaceuticals (NASDAQ: SNDX) announced multiple data presentations for its cancer therapies Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) at the upcoming 30th European Hematology Association Annual Congress in June 2025. The presentations will showcase: For Revuforj: Updated results from the BEAT AML trial combining revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients, data from 77 patients with R/R mNPM1 AML in the AUGMENT-101 trial, and outcomes in patients with R/R NUP98r acute leukemias. For Niktimvo: Data highlighting responses in different organs and subgroups of chronic GVHD patients from the AGAVE-201 trial. The company recently submitted a supplemental NDA for revumenib in R/R mNPM1 AML in April 2025.

Incyte and Syndax's Niktimvo becomes first FDA-approved CSF-1R targeting therapy for chronic GVHD, demonstrating remarkable 75% response rate in patients failing prior treatments.

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NIKTIMVO® (axatilimab) approved by the Therapeutic Goods Administration (TGA) under Priority Review for the treatment of eligible Australian patients with chronic graft-versus-host disease[2] Australia becomes the first country to obtain Marketing Authorisation for NIKTIMVO since approval...