Aug. 13 at 9:49 PM
$GRI GRI Bio, Inc. reported that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead candidate GRI-0621 (tazarotene) for treating idiopathic pulmonary fibrosis, a progressive and ultimately fatal lung disease. This designation is a key regulatory milestone that can support development and potential commercialization.
The status may provide GRI-0621 with potential eligibility for seven years of U.S. market exclusivity upon approval, possible tax credits on qualified clinical expenses, waiver of certain FDA fees and enhanced interaction with the FDA. GRI-0621, a once-daily oral RARβ/γ-selective agonist, previously met primary, secondary and exploratory endpoints in a 35‑patient Phase 2a trial in idiopathic pulmonary fibrosis, most of whom received standard antifibrotic therapy.
