USFDAJun 18, 2026, 04:56 PM
GRI Bio Secures FDA Orphan Drug Designation for IPF Therapy
AI Summary
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 and providing other development benefits. The company highlighted that GRI-0621 has shown promise in a Phase 2a trial, meeting key endpoints and reinforcing its potential to address the unmet medical needs in IPF.
Key Highlights
- GRI Bio, Inc. received Orphan Drug Designation from the FDA for GRI-0621 to treat Idiopathic Pulmonary Fibrosis (IPF).
- The designation provides potential eligibility for seven years of U.S. market exclusivity upon approval.
- GRI-0621 is an investigational oral therapy designed to modulate pathways involved in inflammation and fibrosis in IPF.
- A Phase 2a trial (GRI-0621-IPF-02) in 35 IPF patients met its primary, secondary, and exploratory endpoints.
Price Impact
More from GRI