Designation highlights significant regulatory milestone and provides a potential pathway to seven years of U.S. market exclusivity

LA JOLLA, CA, June 18, 2026 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ:GRI) ("GRI Bio" or the "Company"), a biotechnology company developing innovative therapies for inflammatory, fibrotic and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a progressive, irreversible and ultimately fatal lung disease affecting tens of thousands of patients in the United States.

The designation represents a significant regulatory achievement for GRI-0621 and reinforces the growing recognition of the drug's potential to address significant unmet medical needs in fibrotic diseases.