Syndax said on Monday that its experimental drug axatilimab missed the main goal of a mid-stage study in idiopathic pulmonary fibrosis.
- The trial result ends Syndax’s plans to advance the drug further in idiopathic pulmonary fibrosis.
- The company said the results do not affect ongoing trials of the same drug in other settings.
- Axatilimab is already approved and sold as Niktimvo for chronic graft-versus-host disease, a serious complication that can follow stem-cell transplants.
Syndax Pharmaceuticals (SNDX) shares tumbled 15% after hours on Monday after the company said its experimental drug axatilimab missed the main goal of a mid-stage study in idiopathic pulmonary fibrosis, a progressive and often fatal lung-scarring disease.
SNDX’s Trial Falls Short Of Key Lung Function Goal
The 26-week MAXPIRe study enrolled about 145 patients across 62 sites in 14 countries. Participants were randomly assigned to receive axatilimab or placebo every two weeks, on top of any standard antifibrotic drugs they were already taking. The primary measure was the annualized rate of decline in forced vital capacity—essentially how quickly patients were losing the ability to push air out of their lungs.
Axatilimab did not slow that decline better than placebo. Secondary measures, including time to disease progression and quality-of-life scores, were also reported without evidence of benefit. The result ends Syndax’s plans to advance the drug further in idiopathic pulmonary fibrosis.
Drug Proves Safe But Company Drops IPF Plans
Safety data looked relatively clean. Side effects leading to treatment discontinuation were low and similar between the drug and placebo arms, and no new safety concerns emerged. There were no treatment-related deaths. The most common side effects matched those seen in earlier studies of the medicine.
“The MAXPIRe trial did not meet its primary endpoint, and we are disappointed by this outcome given the promising scientific rationale in IPF,” said Nick Botwood, Syndax’s head of research and development and chief medical officer. The company said the results do not affect ongoing trials of the same drug in other settings.
Syndax Focus Shifts To Existing Blood Disorder Franchise
Axatilimab is already approved and sold as Niktimvo for chronic graft-versus-host disease, a serious complication that can follow stem-cell transplants. Syndax and partner Incyte are testing it in combination regimens for newly diagnosed patients in that indication, with data expected later this year and in early 2028. Chief Executive Michael Metzger said the company remains focused on pushing both axatilimab and its other commercial drug, revumenib, into earlier lines of treatment.
Syndax’s announcement comes on the heels of Bristol Myers Squibb announcing mixed results from its late-stage IPF trial. The company said earlier on Monday that patients receiving a 60 mg twice-daily dose of admilparant showed statistically significant improvement in lung function, while those on the higher 120 mg twice-daily dose did not.
How Did SNDX Retail Traders React?
On Stocktwits, retail sentiment around SNDX stayed within neutral territory over the past 2 months, while message volume rose from normal to high levels.
A Stocktwits user said they bought more shares on the dip, highlighting that the drug has more data due this quarter and is already approved for other indications.
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SNDX stock fell by 21% year-to-date.
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