SNDX - Syndax wins FDA's orphan drug designation for axatilimab in chronic lung disease

Syndax Pharmaceuticals (SNDX) is up ~4.4% in after-hours on the announcement of Orphan Drug Designation granted by the FDA for its anti-CSF-1R monoclonal antibody Axatilimab for the treatment of idiopathic pulmonary fibrosis (“IPF”).Given for drug candidates targeting rare disorders that affect less than 200K people in the U.S., the designation allows the company to claim incentives for the candidate including tax credits and market exclusivity for seven years following the FDA approval.IPF is a chronic lung disease characterized by fibrosis and scarring of lung tissue, and patients have a median survival of 3-5 years after the diagnosis.Axatilimab is undergoing a pivotal Phase 2 trial in skin and lung chronic graft versus host disease (cGVHD) with the primary endpoint being the objective response rate based on the 2014 NIH consensus criteria for GVHD.

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Syndax wins FDA’s orphan drug designation for axatilimab in chronic lung disease