Syndax Pharmaceuticals announced on October 12, 2026, that it is ending its development program for Niktimvo in idiopathic pulmonary fibrosis after the drug failed to meet its primary lung function endpoint in the 145-patient Phase 2 Maxpire trial. The failure sent Syndax shares down up to 17% in extended trading. Syndax and partner Incyte will focus on ongoing clinical trials evaluating Niktimvo in chronic graft-versus-host disease.
Maxpire trial results and program discontinuation
- ▪Niktimvo demonstrated a safety profile comparable to placebo in the Maxpire trial, with no treatment-related deaths and few patient discontinuations due to side effects.
- ▪In the 26-week Maxpire Phase 2 trial, Syndax Pharmaceuticals' drug Niktimvo failed to meet its primary endpoint of slowing the annualized rate of lung function decline in idiopathic pulmonary fibrosis patients compared to placebo.
- ▪The Maxpire Phase 2 trial enrolled 145 patients across 62 study sites in 14 countries.
- ▪Syndax Pharmaceuticals announced on October 12, 2026, that it will stop developing Niktimvo as a treatment for idiopathic pulmonary fibrosis.
Analyst reactions to trial failure
- ▪Mizuho Securities stated that investor expectations for the Maxpire Phase 2 trial were low because testing Niktimvo in idiopathic pulmonary fibrosis involved a novel therapeutic mechanism.
- ▪Jefferies analysts noted that idiopathic pulmonary fibrosis was an secondary indication for Niktimvo, leaving their overall valuation outlook for Syndax Pharmaceuticals largely unchanged by the trial failure.
Syndax stock price decline
- ▪Syndax Pharmaceuticals stock fell 10% from $16.55 at market close on October 12, 2026, to $14.89 per share in premarket trading on October 13, 2026.
- ▪Syndax Pharmaceuticals shares dropped approximately 17% in extended trading on October 12, 2026, following the announcement of the failed Phase 2 trial.
Niktimvo background and regulatory history
- ▪Niktimvo is a monoclonal antibody that targets and blocks the colony-stimulating factor-1 receptor protein to reduce immune cell activity responsible for lung tissue scarring in idiopathic pulmonary fibrosis.
- ▪The U.S. Food and Drug Administration granted Niktimvo orphan drug status for idiopathic pulmonary fibrosis in April 2021.
Niktimvo status in graft-versus-host disease
- ▪Syndax Pharmaceuticals and partner Incyte are evaluating Niktimvo combination therapies for newly diagnosed chronic graft-versus-host disease across two ongoing studies, with data readouts expected in late 2026 and early 2028.
- ▪Niktimvo is approved in the United States under the commercial name axatilimab for treating chronic graft-versus-host disease in patients who failed at least two prior lines of therapy.
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