Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Chronic Graft Versus Host Disease

Syndax Pharmaceuticals Inc.. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of patients with chronic graft versus host disease (cGVHD).

“Receipt of Orphan Drug Designation underscores axatilimab’s potential to serve as a safe and effective intervention for patients with cGVHD,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Through its ability to inhibit monocyte derived macrophages, which play a key role in the fibrotic disease process, we believe axatilimab could represent a meaningful therapeutic approach for cGVHD, as well as other fibrotic diseases. As previously announced, our pivotal Phase 2 AGAVE-201 trial is now underway in patients with cGVHD, with topline results expected in 2023.”

The FDA’s Office of Orphan Drug Products grants Orphan Drug Designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years upon FDA approval.

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