GRI Bio, Inc. (NASDAQ: GRI) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational therapy, GRI-0621, aimed at treating Idiopathic Pulmonary Fibrosis (IPF).
This progressive and fatal lung disease impacts tens of thousands of patients in the U.S. The designation highlights the drug’s potential to meet significant unmet medical needs in fibrotic diseases.
GRI-0621 is an oral therapy that selectively targets RARβ/γ pathways involved in inflammation and fibrosis associated with IPF.
Orphan Drug Designation is reserved for treatments addressing rare diseases affecting fewer than 200,000 people in the U.S.
Marc Hertz, Ph.D., Chief Executive Officer, stated, “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.”
 has been granted Orphan Drug Designation by the FDA for GRI-0621, a therapy for Idiopathic Pulmonary Fibrosis.){kind=link}