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GRI Bio's GRI-0621 gains FDA Orphan Drug Designation for treating fatal lung disease IPF

Market News
18 Jun 2026
GlobeNewsWire
View Source
Bullish
pluang ai news

GRI Bio, Inc. announced that the FDA granted Orphan Drug Designation to its investigational drug GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), a severe and progressive lung disease. This designation offers benefits like seven years of U.S. market exclusivity, tax credits, and fee waivers, supporting the drug's development and commercialization. GRI-0621, an oral therapy targeting inflammation and fibrosis, showed positive results in a Phase 2a trial, addressing a significant unmet medical need. The designation marks a key regulatory milestone, enhancing GRI Bio's ability to advance this promising treatment for IPF patients.

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