Syndax says mid-stage trial of lung disease treatment fails main goal, ends development

By Reuters News

Oct 12 (Reuters) - Syndax Pharmaceuticals SNDX.O said on Monday it will stop developing a treatment for idiopathic pulmonary fibrosis, a chronic lung-scarring disease, after a mid-stage trial failed to meet its main goal.

Shares of the cancer therapy maker fell about 17% in extended trading.


  • The company said the result does not affect ongoing studies of axatilimab in chronic graft-versus-host disease, a serious complication that can occur after bone marrow transplants. The drug is already approved in the US for that condition.

  • Syndax said the mid-stage study failed to meet its main goal of reducing the annual rate of lung function decline compared with placebo.

  • The company said it will not pursue further development of the treatment in idiopathic pulmonary fibrosis.

  • According to Syndax, the treatment was well tolerated and showed a safety profile comparable to placebo, with no new safety concerns identified.

  • The company said there were no treatment-related deaths in either study arm and few patients stopped treatment because of side effects.

  • The 26-week study enrolled patients across 62 sites in 14 countries.

  • The treatment, sold as Niktimvo, is approved in the United States for chronic graft-versus-host disease after failure of at least two prior treatments.

  • Syndax and partner Incyte INCY.O continue to study the treatment in newly diagnosed chronic graft-versus-host disease, with additional trial results expected later this year and in early 2028.

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