Business
GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis
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 Pulm
About this update from Gri Bio, Inc.
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. "Receiving FDA Orphan Drug Designation for GRI-0621 in IPF is an important validation of our development strategy and highlights the urgent need for innovative therapies capable of altering the course of this devastating disease," said Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio. "We believe GRI-0621's differentiated mechanism of action has the potential to address key drivers of inflammation and fibrosis, and this designation strengthens our ability to advance the program efficiently while creating significant long-term value for patients and shareholders." Orphan Drug Designation is granted to therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides important development and commercialization benefits, including: IPF remains one of the most challenging pulmonary diseases, characterized by progressive scarring of lung tissue that leads to declining lung function and premature mortality. Despite currently approved therapies, patients continue to face poor long-term outcomes, underscoring the need for additional treatment options. GRI-0621 an oral, RARβ/γ-selective investigational therapy designed to modulate pathways involved in inflammation and fibrosis in IPF. Emerging scientific evidence increasingly supports the role of immune dysfunction in driving fibrosis, creating opportunities for novel therapeutic approaches beyond current standards of care. GRI-0621, the Company’s once-daily oral RARβ/γ selective agonist, ...