Common Stock, par value $0.0001 per share
- Symbol
- GRI
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01, 9.01 · 8-K
GRI Bio, Inc.
GRINASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On June 18, 2026, GRI Bio, Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration has granted Orphan Drug Designation to GRI-0621 for the treatment of idiopathic pulmonary fibrosis. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.
Company context
GRI Bio is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory, fibrotic and autoimmune diseases. The Company's lead program, GRI-0621, is an oral RARβ/γ-selective agonist being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and life-threatening fibrotic lung disease with significant unmet need. GRI-0621 is designed to modulate pathways associated with inflammation, fibrosis and tissue repair and is being evaluated as a potential novel oral therapeutic for patients with IPF.
Current securities
Recent company filings
- Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Submission of Matters to a Vote of Security HoldersNov 4, 2026
- ARS filingSep 28, 2026
- DEF 14A filingSep 28, 2026
- Regulation FD Disclosure · Other EventsSep 8, 2026
- 10-Q filingAug 14, 2026
Registered securities in this filing
GRI BIO, INC. · 8-K · Filed 2026-06-18
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On June 18, 2026, GRI Bio, Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration has granted Orphan Drug Designation to GRI-0621 for the treatment of idiopathic pulmonary fibrosis. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.
Filed exhibits (1)
EX-99.1 2 ex991_pressreleaseodd.htm EX-99.1 Document Exhibit 99.1 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 -- 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 alteri…
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