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GRI Bio reports developments from its clinical-stage biopharmaceutical pipeline of Natural Killer T cell modulators for inflammatory, fibrotic and autoimmune diseases. Recurring updates center on GRI-0621, an RARβγ agonist being developed as an oral therapy for idiopathic pulmonary fibrosis, including Phase 2a clinical, biomarker, immune-profiling and gene-expression data.
The company also issues news on GRI-0803 and other type 2 diverse NKT agonist programs, patents covering dNKT agonists and novel compound compositions, its proprietary compound library, financial results, equity financings, Nasdaq compliance matters, reverse stock split actions and conference participation.
GRI Bio (GRI) reported new Phase 2a IPF data for oral RARβ/γ agonist GRI-0621, showing exploratory lung function and mechanistic signals after 12 weeks.
In 35 randomized patients, 39% on GRI-0621 achieved ≥30 mL FVC increase versus 20% on placebo, rising to 50% with background antifibrotics. Only 8% on GRI-0621 had ≥10% FVC decline versus 20% on placebo, and placebo-adjusted mean FVC change was +99 mL overall and +139 mL on standard-of-care therapy. Ten post hoc FVC sensitivity analyses remained directionally positive. Biomarker data across RNA sequencing, serum ECM markers and spectral flow cytometry supported nine pre-specified mechanistic pillars, including immune re-balancing, myofibroblast inhibition, fibrolysis and basement-membrane repair. GRI-0621 was well tolerated with 0% serious treatment-emergent adverse events versus 8% on placebo and lower rates of cough, dyspnea and diarrhea.
GRI Bio (NASDAQ: GRI) announced that it is featured in a "Why Now" on-demand video webcast. CEO Marc Hertz, Ph.D., discusses the company’s differentiated approach to treating idiopathic pulmonary fibrosis (IPF) with GRI-0621, a once-daily oral RARβ/γ-selective agonist targeting inflammation, fibrosis and tissue repair pathways.
The webcast also addresses GRI-0621’s mechanism of action and the remaining unmet need in IPF. GRI Bio notes it has been selected to present data related to GRI-0621 at the 2026 European Respiratory Society Congress in Barcelona. The webcast is available for on-demand viewing.
GRI Bio (NASDAQ: GRI) announced that three abstracts and one late-breaking oral presentation from its Phase 2a GRI-0621-IPF-02 trial in idiopathic pulmonary fibrosis (IPF) have been accepted for the 2026 European Respiratory Society Congress in Barcelona, Spain, on September 5–9, 2026.
According to the company, the data will cover safety and tolerability, translational biomarker profiles, and the potential impact on lung function of GRI-0621, an oral RARβ/γ-selective agonist. The late-breaking oral presentation (OA2380; abstract 63931) is scheduled for September 6, 2026, from 3:45–5:00 PM CEST. Three posters on lung function (FVC after 12 weeks), gene-expression and anti-fibrotic biomarker signals, and a safety signal indicating favorable tolerability will be presented earlier that day from 8:00–9:30 AM CEST.
GRI Bio (NASDAQ: GRI) received FDA Orphan Drug Designation for GRI-0621 (tazarotene) to treat idiopathic pulmonary fibrosis (IPF). The designation may provide seven years of U.S. market exclusivity, tax credits, fee waivers and enhanced FDA interaction. GRI-0621 met primary, secondary and exploratory endpoints in a 35-patient Phase 2a IPF trial.
GRI Bio (NASDAQ: GRI) will participate in A.G.P.’s Annual Healthcare Company Showcase via a virtual fireside chat on Wednesday, May 20, 2026. CEO Marc Hertz, PhD, will discuss the company’s immune-modulating NKT cell pipeline targeting inflammatory, fibrotic and autoimmune diseases.
A live webcast will be available on the Events page in the Investors section of gribio.com.
GRI Bio (NASDAQ: GRI) reported Q1 2026 results and clinical updates for IPF candidate GRI-0621.
Phase 2a in idiopathic pulmonary fibrosis met its primary safety endpoint, showing zero cough, reduced dyspnea, no weight loss and 61% less diarrhea versus placebo, alongside FVC improvements.
Cash was $11.0 million, with runway into Q2 2027.
GRI Bio (NASDAQ: GRI) received a Notice of Allowance from the United Arab Emirates Patent Office on April 8, 2026, for UAE Patent No. P6000687/2017 titled “Prevention and Treatment of Inflammatory Conditions.”
The allowed claims cover novel type 2 diverse NKT (dNKT) cell agonists and related methods, expanding the company’s global IP protection for its immunomodulatory platform and supporting future regional partnerships, licensing and commercialization in the UAE and MENA region.
GRI Bio (NASDAQ: GRI) said CEO Marc Hertz was featured in a Virtual Investor “What This Means” segment on February 17, 2026. Hertz discussed additional positive Phase 2a data in idiopathic pulmonary fibrosis (IPF), highlighting biomarker improvements tied to fibrosis and lung repair.
The segment is available via the company's virtual investor content library for investors seeking details on the biomarker results and clinical implications.
GRI Bio (NASDAQ: GRI) will participate in the Corporate Connect Webinar Series hosted by Webull Financial, held virtually February 10-11, 2026. The company will deliver a live video webcast presentation on Wednesday, February 11, 2026 at 1:00 PM EST, presented by Marc Hertz, PhD.
Registration is available via the company's provided link. The presentation will cover GRI Bio's pipeline and corporate update for investors.
GRI Bio (NASDAQ: GRI) reported year-end $8.2 million in cash and cash equivalents as of December 31, 2025 and raised an additional $6.5 million in January 2026, strengthening the balance sheet to fund operations into Q1 2027. Key clinical highlights include positive Phase 2a topline data for GRI-0621 in idiopathic pulmonary fibrosis, supplemental RNA‑seq and immune phenotype data reinforcing proof‑of‑concept, and advancement of GRI-0803 toward IND‑enabling studies for autoimmune indications.