GRI Bio Receives FDA Orphan Drug Designation for GRI-0621 in Idiopathic Pulmonary Fibrosis

On June 18, 2026, GRI Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, GRI-0621, for the treatment of Idiopathic Pulmonary Fibrosis (IPF). GRI-0621 is a once-daily, oral RARβ/γ-selective agonist designed to modulate pathways involved in inflammation and fibrosis. The designation provides the company with several potential benefits, including seven years of U.S. market exclusivity upon regulatory approval, tax credits for qualified clinical development expenses, and a waiver of certain FDA application fees. The ODD follows a randomized, double-blind, placebo-controlled Phase 2a trial (GRI-0621-IPF-02) involving 35 patients, which met its primary, secondary, and exploratory endpoints. Approximately 80% of participants in that trial were on background standard-of-care antifibrotics. GRI Bio continues to advance its pipeline, which also includes type 2 diverse NKT agonists for systemic lupus erythematosus. The company noted that substantial additional capital will be required to fund a planned Phase 2b clinical trial of GRI-0621.