GRI Bio, Inc. 8-K

What Happened
GRI Bio, Inc. (GRI) announced on June 18, 2026 (via an 8‑K and an attached press release) that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its candidate GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF). The press release is included as Exhibit 99.1 to the Form 8‑K.

Key Details

• Date of filing/announcement: June 18, 2026.
• Regulatory action: FDA granted Orphan Drug Designation to GRI-0621 for idiopathic pulmonary fibrosis.
• Disclosure format: Announcement made via Form 8‑K with a press release attached as Exhibit 99.1.
• Report signed on behalf of the company by CFO Leanne Kelly.

Why It Matters
Orphan Drug Designation is a regulatory milestone that can provide benefits such as potential tax credits, grant eligibility, FDA development support, and seven years of market exclusivity if the drug is approved. For investors, this designation signals a recognized regulatory pathway for GRI-0621 in a serious, unmet-need indication (IPF), but it is not an approval and does not guarantee clinical or commercial success. The filing contains no financial results or other corporate changes; it is strictly a disclosure of the FDA designation.