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Syndax Pharmaceuticals Stops Axatilimab Lung Disease Program After Phase 2 Trial Fails

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SNDX$16.55 −2.59%

Syndax Pharmaceuticals Inc (NASDAQ:SNDX) announced it will discontinue development of axatilimab in idiopathic pulmonary fibrosis (IPF) after a mid-stage clinical study missed its main goal. The Phase 2 MAXPIRe trial failed to meet its primary endpoint of reducing forced vital capacity decline in patients.

The strategic halt removes an important potential pipeline expansion path and reduces the asset's overall market opportunity. Despite missing the primary efficacy target, safety outcomes for axatilimab were comparable to placebo, demonstrating that the trial outcome was not driven by safety concerns.

Syndax noted that its broader development plans for axatilimab remain on track. Ongoing clinical trials testing the drug for chronic graft-versus-host disease (cGVHD) are unaffected by the IPF result, with upcoming readouts expected later this year and in early 2028. Following the announcement, Syndax shares declined 2.59% to $16.55.

Key points

  • Syndax Pharmaceuticals discontinued its axatilimab program in idiopathic pulmonary fibrosis after missing the main endpoint in the Phase 2 MAXPIRe trial.
  • The trial failed to show a significant reduction in forced vital capacity decline, though safety results were comparable to placebo.
  • Ongoing clinical studies investigating axatilimab in chronic graft-versus-host disease are unaffected, with readouts expected later this year and in early 2028.
  • Syndax Pharmaceuticals Inc (NASDAQ:SNDX) shares fell 2.59% to $16.55 following the announcement.

Written by our AI from expert market sources across the web. It can contain mistakes: check the facts before acting on them. Write-ups powered by the free AI API at FreeTheAI.org

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Questions and answers

Why did Syndax Pharmaceuticals stop its axatilimab trial for IPF?

Syndax stopped the axatilimab IPF program because the Phase 2 MAXPIRe trial failed to meet its primary endpoint of forced vital capacity decline.

Are other Syndax clinical trials affected by the axatilimab trial failure?

No. Ongoing trials investigating axatilimab in chronic graft-versus-host disease remain unaffected, with study readouts scheduled for later this year and early 2028.

Were there safety concerns in the axatilimab MAXPIRe trial?

No. Safety in the Phase 2 MAXPIRe trial was comparable to placebo, indicating the study miss was related to efficacy rather than safety issues.