On October 12, 2026, said its MAXPIRe trial of axatilimab in missed its — the annualized rate of decline in .
The trial enrolled 145 patients across 62 sites in 14 countries. It ran 26 weeks, randomized patients 2:1 to axatilimab or placebo every two weeks, and was double-blind and placebo-controlled.
A 145-patient trial across 14 countries is large enough that the miss is a real result, not a small-study fluke.
The drug was on safety, with no new safety signals and no treatment-related fatal adverse events in either arm. The failure was on efficacy, not safety.
Syndax said it does not plan to move forward with further development of axatilimab in IPF. The results do not affect ongoing trials of the drug in other diseases.
Axatilimab is a . It is FDA approved for after at least two prior lines of systemic therapy.
Syndax licensed axatilimab from in 2016. In September 2021, Syndax and signed a worldwide co-development and co-commercialization agreement for the drug in cGVHD and any future indications.
Axatilimab is in multiple cGVHD trials, with results expected later in 2026 and early 2028. Those include a Phase 2 combination trial with ruxolitinib and a Phase 3 combination trial with steroids, both testing the drug as a treatment.
The IPF failure leaves the approved cGVHD business and the push into frontline cGVHD untouched — the drug's commercial future does not depend on the lung indication.
, Syndax's chief executive, said the company is focused on advancing axatilimab and revumenib to frontline and building Niktimvo into a franchise in cGVHD with Incyte.
, Syndax's head of research and development and chief medical officer, said the company was disappointed by the outcome given the scientific rationale for testing the drug in IPF.
Syndax's other approved drug is revumenib, a menin inhibitor for certain acute leukemias.