Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Idiopathic Pulmonary Fibrosis

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 idiopathic pulmonary fibrosis (IPF).

“IPF is a serious, life-limiting orphan disease, and today’s Orphan Drug Designation validates axatilimab’s potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. “Building on promising data demonstrating meaningful multiorgan clinical benefit in patients with chronic graft versus host disease, we are actively evaluating options to expand the axatilimab franchise into additional areas of high unmet need where the monocyte-macrophage lineage plays a key role in the fibrotic disease process. We look forward to providing updates on these plans in the coming months.”

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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