Shares of Syndax Pharmaceuticals and Incyte surged in premarket trading following the announcement that their pivotal Phase 2 study of axatilimab has achieved its primary endpoint in treating a serious complication that can occur after a stem-cell or bone-marrow transplant.
Successful Treatment for Chronic Graft-Versus-Host Disease
The study, which involved adult and pediatric patients with chronic graft-versus-host disease who had not responded to previous therapies, demonstrated a remarkable overall response rate of 74% when administered at a dose of 0.3 milligrams per kilogram every two weeks.
Plans for FDA Approval
Buoyed by these encouraging results, Syndax Pharmaceuticals and Incyte have announced plans to seek regulatory approval from the U.S. Food and Drug Administration for axatilimab by the year-end.
Collaboration between Syndax and Incyte
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company based in Waltham, Mass., partnered with Incyte, a biopharmaceutical company headquartered in Wilmington, Del. In 2021, the two companies sealed an agreement to jointly develop and commercialize Syndax’s axatilimab drug candidate. Under the terms of the agreement, Syndax received an initial payment of $152 million, with the potential to earn hundreds of millions of dollars in milestone payments.
Positive Market Response
Following the announcement, Syndax Pharmaceuticals’ stock jumped 14% from its previous closing price to $24.21 in premarket trading. Incyte’s shares also experienced a slight increase of 1.9% to $65.39.