Syndax to Halt Axatilimab Development After Fibrosis Trial Miss

what happened

According to Newsmetry API, Syndax Pharmaceuticals’ trial of axatilimab for idiopathic pulmonary fibrosis failed to achieve its primary objective. Based on the findings, the New York-based drugmaker does not intend to continue developing the medicine for the lung condition.

The Phase 2 study missed its goal for the annualized decline in forced vital capacity, a measure of how much air a patient can expel forcefully following a deep breath. The 26-week trial enrolled 145 patients. Axatilimab’s safety and tolerability results were in line with earlier studies.

Syndax shares fell 13% to $14.45 in Monday’s after-hours trading. The Food and Drug Administration has already approved axatilimab for patients with chronic graft-versus-host disease after two previous therapies have failed. The condition can develop following stem-cell or bone-marrow transplants. The drug is also being tested alongside other treatments in newly diagnosed graft-versus-host disease. The report was written by Katherine Hamilton, who can be reached at katherine.hamilton@wsj.com.

why it matters

The failed endpoint removes a potential development path for axatilimab in pulmonary fibrosis and was reflected in a 13% after-hours decline in Syndax shares.

instruments