GRI Bio's GRI-0621 Receives FDA Orphan Drug Designation for IPF

GRI Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy, GRI-0621, for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This designation is a significant regulatory milestone, potentially offering seven years of U.S. market exclusivity upon approval, tax credits, and waived FDA fees. GRI-0621, an oral RARβ/γ-selective agonist, previously met all primary, secondary, and exploratory endpoints in a Phase 2a trial involving 35 IPF patients. The company views this as validation of its development strategy and a step towards addressing significant unmet medical needs in fibrotic diseases.