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Syndax Announces Topline Results from MAXPIRe Phase 2 Trial of Axatilimab in Idiopathic Pulmonary Fibrosis

Globe Newswire•12/10/2026•16:01 ET
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Key Highlights

  • ➤MAXPIRe Phase 2 missed its primary endpoint, annualized FVC decline
  • ➤Syndax will not pursue further axatilimab development in IPF
  • ➤Axatilimab safety profile comparable to placebo, with no new safety signals
  • ➤cGVHD axatilimab trial readouts expected later this year and early 2028

Expert Statements

Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax

“The MAXPIRe trial did not meet its primary endpoint, and we are disappointed by this outcome given the promising scientific rationale in IPF”

Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax

“We sincerely thank the patients, caregivers, clinicians and study teams who participated.”

Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax

“Axatilimab was well tolerated, with a safety profile consistent with prior studies supporting its continued development and use in cGVHD.”

Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax

“There are multiple trials underway in cGVHD where axatilimab has shown remarkable results and we look forward to readouts from these trials later this year and in early 2028.”

Michael A. Metzger, Chief Executive Officer of Syndax

“We remain highly focused on further advancing revumenib and axatilimab to frontline in the ongoing clinical trials which will unlock significant value for patients and shareholders.”

Michael A. Metzger, Chief Executive Officer of Syndax

“And we are well positioned to deliver breakthroughs for patients and build long-term value, with a robust pipeline, multiple upcoming catalysts, and strong financial position.”

Michael A. Metzger, Chief Executive Officer of Syndax

“We look forward to working with our partner Incyte as we continue to build Niktimvo into a blockbuster franchise in cGVHD.”

– Trial did not meet the primary endpoint of annualized rate of FVC decline –

– Axatilimab was well tolerated with a safety profile comparable to placebo; no new safety signals were observed –

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