Every material Form 8-K GRI Bio, Inc. has filed with the SEC since June 18, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
At its November 4, 2026 virtual annual meeting, GRI Bio stockholders approved an amendment to the 2018 Equity Incentive Plan that adds 546,529 shares and extends the evergreen provision to January 1, 2036, and re-elected Class III director nominees W. Marc Hertz and David Szekeres. The plan vote was 136,205 for and 102,978 against, with 684,435 broker non-votes, so the approval reflects a narrow margin of votes cast and a larger share of shares not voting on the plan.
Plan amendment: 546,529 additional shares reserved and evergreen provision extended to January 1, 2036; votes were 136,205 for, 102,978 against, 2,856 abstained, and 684,435 broker non-votes
Directors: W. Marc Hertz, Ph.D. and David Szekeres elected as Class III directors to serve until the 2029 Annual Meeting
Auditor: WithumSmith+Brown, PC ratified as independent registered public accounting firm for fiscal year ending December 31, 2026 (883,489 for, 23,019 against)
Quorum: 926,474 shares, or about 42.37% of 2,186,115 eligible shares as of the September 22, 2026 record date, were present or represented
GRI Bio, Inc. issued a press release on September 8, 2026 presenting new translational biomarker data from its Phase 2a GRI-0621-IPF-02 study of oral tazarotene in idiopathic pulmonary fibrosis, and posted an updated corporate presentation. The filing reports that the 12-week, 35-patient study showed a placebo-adjusted FVC change of +99 mL overall, but the company states the study was not powered for efficacy and the FVC endpoint was exploratory, so the data do not establish clinical benefit.
Placebo-adjusted FVC change from baseline at Week 12 was +99 mL overall and +139 mL in the subset on background standard-of-care antifibrotic therapy.
The study enrolled 35 patients: 23 on GRI-0621 and 12 on placebo; the FVC endpoint was exploratory and the study was not powered for efficacy.
Data were presented at the 2026 European Respiratory Society Congress in Barcelona, Spain, and the company said totality of findings supports advancing GRI-0621 in the IPF program.
The filing was made under Items 7.01, 8.01 and 9.01 and includes Exhibits 99.1 (corporate presentation) and 99.2 (press release).
GRI Bio said on June 18, 2026 that the U.S. Food and Drug Administration granted Orphan Drug Designation to GRI-0621, its oral investigational therapy for idiopathic pulmonary fibrosis (IPF). The designation provides potential benefits such as seven years of U.S. market exclusivity upon approval, but the filing does not report revenue, earnings, or changes to guidance.
FDA granted Orphan Drug Designation to GRI-0621 for IPF, announced June 18, 2026
Orphan designation applies to diseases affecting fewer than 200,000 people in the U.S.; benefits include potential seven years of U.S. market exclusivity upon approval
GRI-0621 was evaluated in a 35-patient Phase 2a trial (GRI-0621-IPF-02), which the company says met its primary, secondary and exploratory endpoints
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