GRI Bio, Inc.

New whole blood RNA sequencing data identified coordinated, consistent change in genes governing immune re-balancing, myofibroblast inhibition, fibrolysis, basement membrane repair, re-epithelialization, antitussive effect and GI protection Signals observed from at least two independent measurement modalities, including RNA sequencing, serum extracellular matrix biomarkers, spectral flow cytometry and clinical readouts, supported each of the nine pre-specified mechanistic pillars, defining a repair phenotype with anti-fibrotic and pro resolving effects Approximately 2x-2.5x as many GRI-0621-treated patients experienced an FVC increase compared with placebo; placebo-adjusted FVC change from baseline at Week 12 was +99 mL overall and +139 mL on background standard-of-care antifibrotic therapy Totality of Phase 2a findings supports advancement of GRI-0621 in the IPF program and further evaluation in a longer-duration study LA JOLLA, CA, Sept. 08, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company developing innovative therapies for inflammatory, fibrotic and autoimmune diseases, today announced new translational biomarker data from the Phase 2a GRI-0621-IPF-02 study evaluating GRI-0621 (oral tazarotene) in patients with idiopathic pulmonary fibrosis (“IPF”). The new data, together with the study’s lung function and safety results, were presented in a late-breaking oral presentation and three posters at the 2026 European […]

Video webcast now available here LA JOLLA, CA, Aug. 27, 2026 (GLOBE NEWSWIRE) — 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 it is featured in a “Why Now” video webcast. During the webcast, Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio, discusses the Company’s differentiated approach to treating idiopathic pulmonary fibrosis (IPF) through GRI-0621, a once-daily oral, RARβ/γ-selective agonist designed to modulate the biological pathways associated with inflammation, fibrosis and tissue repair. The discussion also highlights GRI-0621’s differentiated mechanism of action and the significant unmet need that remains for patients living with IPF. As previously announced, GRI has been selected for presentation at the 2026 European Respiratory Society (ERS) Congress, being held September 5-9 in Barcelona, Spain, where it will present on data that it believes is supportive of GRI-0621’s differentiated mechanism and its potential to address the underlying biology of IPF. The video webcast is now accessible for on-demand viewing here. JTC Team and Virtual Investor Co. are paid consultants to GRI Bio, Inc. JTC Team and Virtual Investor Co. are investor relations and corporate communications firms. Any content included […]

LA JOLLA, CA, Aug. 24, 2026 (GLOBE NEWSWIRE) — 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 three abstracts and an oral presentation highlighting data from the Phase 2a GRI-0621-IPF-02 study have been selected for presentation at the 2026 European Respiratory Society (ERS) Congress, being held September 5-9, 2026 in Barcelona, Spain. The presentations will include a late-breaking oral presentation as well as three posters evaluating the safety and tolerability, translational biomarker profile and potential impact on lung function of GRI-0621, the Company’s oral retinoic acid receptor (“RAR”) β/γ-selective agonist being developed for the treatment of idiopathic pulmonary fibrosis (“IPF”). “The breadth of data being presented at ERS marks an important step forward for GRI-0621 and our understanding of its potential in IPF,” said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Across lung function, translational biomarkers and safety, we are seeing encouraging and complementary signals that support GRI-0621’s differentiated mechanism and its potential to address the underlying biology of this devastating disease. We believe these findings provide a compelling foundation for the continued advancement of GRI-0621 and reinforce our conviction in […]

Designation highlights significant regulatory milestone and provides a potential pathway to seven years of U.S. market exclusivity LA JOLLA, CA, June 18, 2026 (GLOBE NEWSWIRE) — 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 altering the course of this devastating disease,” said Marc Hertz, Ph.D., Chief Executive Officer of GRI Bio. “We believe GRI-0621’s differentiated mechanism of action has the potential to address key drivers of inflammation and fibrosis, and this designation strengthens our ability to advance the program efficiently while creating significant long-term value for patients and […]

Phase 2a data show zero cough and 60% lower treatment-related diarrhea than placebo despite higher nintedanib use in the active arm – suggesting GRI-0621 may mitigate nintedanib-related GI-toxicities when used in combination Advancing GRI-0803 toward IND-enabling activities to expand the pipeline across autoimmune indications with high unmet need LA JOLLA, CA, May 14, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced reported financial results for the quarter ended March 31, 2026 and provided a corporate update. “The growing body of Phase 2a clinical, translational and biomarker data continues to reinforce GRI-0621’s differentiated therapeutic potential in idiopathic pulmonary fibrosis (IPF),” said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Additional analyses in the Phase 2a study show that GRI-0621 delivered zero cough, reduced dyspnea, zero weight loss and approximately 60% less treatment-related diarrhea when added to standard of care versus standard of care alone, with no serious adverse events in the active arm – directly addressing the tolerability burdens that drive discontinuations of current IPF therapies. These data, together […]

Issued claims further strengthen global intellectual property portfolio supporting immune cell modulation platform and expand strategic presence in a high-growth international market LA JOLLA, CA, April 08, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that it has received a Notice of Allowance from the United Arab Emirates Patent Office (UAE) 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 and compositions for the prevention and treatment of inflammatory conditions, further expanding GRI Bio’s intellectual property protection for its proprietary immunomodulatory platform. These claims support therapeutic approaches targeting immune pathways implicated in inflammatory, fibrotic and autoimmune diseases and complement the Company’s existing patent portfolio. This allowance further reinforces the Company’s disciplined approach to building a global intellectual property portfolio designed to support long-term exclusivity and strategic optionality. The UAE represents a strategically significant and rapidly expanding healthcare market, serving as a gateway to the broader Middle East and North Africa (MENA) […]

Access the “What This Means” segment here LA JOLLA, CA, Feb. 17, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that it participated in a Virtual Investor “What This Means” segment. As part of the segment, Marc Hertz, PhD, President, Chief Executive Officer and Director of GRI Bio, discussed important insights from the Company’s recently reported additional positive Phase 2a data in Idiopathic Pulmonary Fibrosis (IPF), including a series of compelling biomarker results that demonstrate improvements in key drivers of fibrosis and lung repair. The “What This Means” segment can be accessed here. About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are […]

– Live video webcast on Wednesday, February 11th at 1:00 PM EST LA JOLLA, CA, Feb. 05, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of immune cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that it will participate in the Corporate Connect Webinar Series hosted by Webull Financial being held virtually February 10-11, 2026. Details of the presentation are as follows:Date and Time: Wednesday, February 11, 2026 at 1:00 PM ESTPresenter: Marc Hertz, PhD, President, Chief Executive Officer and DirectorRegistration Link: Here About Webull Financial Webull Financial is a leading online brokerage platform committed to empowering self-directed investors with innovative tools and cutting-edge technology. With low-cost trading on a wide range of assets, advanced charting tools, and real-time market data, Webull is revolutionizing the way individuals approach investing. The user-centric approach and commitment to staying at the forefront of industry trends underscore the mission to provide a seamless and rewarding experience for traders of all levels. Through the Webull Group, Webull Financial and its affiliates combine to serve tens of millions of users from over 180 countries worldwide. Securities and futures […]

Company reported $8.2 million in cash and cash equivalents at December 31, 2025 and raised additional $6.5 million in gross proceeds in January 2026 Balance sheet strengthened to fund operations into Q1 2027 Strong Phase 2a clinical data for GRI-0621 in idiopathic pulmonary fibrosis reinforce clinical proof-of-concept and therapeutic differentiation GRI-0803 focused on autoimmune indications with high unmet need advancing through IND-enabling activities LA JOLLA, CA, Feb. 04, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of immune cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases today summarized recently reported Full Year 2025 financial results, provided an update on the Company’s current cash position and cash runway and summarized key clinical and corporate highlights. “In 2025, we prioritized disciplined clinical execution and balance sheet strength, delivering compelling clinical data from our lead IPF program which underscores the therapeutic differentiation of GRI-0621,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Entering 2026 with a strong cash position, we are focused on advancing GRI-0621 in IPF, progressing GRI-0803 toward the clinic and executing our clinical strategy with capital discipline to drive long-term value creation.” […]

Multiple Independent Molecular Signals Converge to Validate GRI-0621 as a Potential Disease-Modifying Therapy LA JOLLA, CA, Jan. 28, 2026 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of immune cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced additional positive data from its recently completed Phase 2a clinical study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”), further strengthening potential clinical proof-of-concept and reinforcing the therapeutic differentiation of GRI-0621. Newly reported RNA-sequencing differential gene expression data demonstrate that treatment with GRI-0621 resulted in significant improvement across genes associated with lung injury, myofibroblast activation, extracellular matrix deposition, fibrosis progression, and alveolar basement membrane and epithelial repair compared to placebo. These findings represent a potential powerful and independent validation of previously reported biomarker, functional and clinical signals from the Phase 2a study. Gene Expression Data Show Direct Impact on the Core Biology of IPF IPF is driven by ongoing epithelial injury, unchecked fibroblast activation and irreversible scarring of lung tissue. In the Phase 2a study, subjects treated with GRI-0621 demonstrated clear and significant differentially expressed genes (“DEGs”) linked to key drivers of disease, supporting a mechanism consistent […]