GRI Bio to Present Late-Breaking Phase 2a GRI-0621 Data Highlighting Lung Function, Anti-Fibrotic Biomarkers and Favorable Tolerability in IPF at ERS 2026
Rhea-AI Summary
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.
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Market reaction after Phase 2a clinical data: GRI +13.33%
Following this news, GRI has gained 13.33%, reflecting a significant positive market reaction. Our momentum scanner has triggered 10 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $1.87. Trading volume is exceptionally heavy at 19.5x the average, suggesting very strong buying interest.
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Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 18 | Orphan drug designation | Positive | -19.0% | FDA granted orphan designation for GRI-0621 after positive Phase 2a trial endpoints. |
| May 18 | Healthcare showcase presentation | Neutral | +5.4% | Company announced CEO participation in a virtual healthcare company showcase. |
| May 14 | Quarterly earnings report | Positive | -4.9% | Quarterly results included supportive Phase 2a safety, biomarker and lung-function data. |
| Apr 08 | Patent allowance | Positive | +4.3% | UAE patent office allowed claims covering type 2 diverse NKT cell agonists. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
GRI Bio's recent news reactions were mixed, with positive clinical and corporate developments producing both declines and gains.
Key Terms
idiopathic pulmonary fibrosis medical
rarβ/γ-selective agonist medical
fvc medical
placebo controlled trial medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 its potential to meaningfully impact the treatment landscape for patients with IPF.”
Details of the presentations are as follows:
Late-Breaking Oral
Title: Safety, translational biomarkers and lung function with the oral RARβ/γ-selective agonist GRI-0621 in idiopathic pulmonary fibrosis: a Phase 2a randomised, double-blind, placebo controlled trial (GRI-0621-IPF-02)
Presentation Number: OA2380
Abstract Number: 63931
Session: 12.04 – Rare ILD/DPLD
Presenter: Helen Parfrey, MA PhD FRCP
Date and Time: Sunday, September 6, 2026, from 3:45–5:00 PM CEST
Lung Function
Title: GRI-0621 phase 2a biomarker study in patients with IPF: GRI-0621 has a positive effect on FVC after 12 weeks of treatment
Poster Number: PA897
Abstract Number: 62491
Session: 12.04 – Rare ILD/DPLD
Presenter: Joanna C. Porter, PhD FRCP
Date and Time: Sunday, September 6, 2026, from 8:00–9:30 AM CEST
Translational Biomarkers
Title: GRI-0621 Phase 2a biomarker study in patients with IPF using gene expression, immune cell activity and collagen markers supports a repair phenotype with strong anti-fibrotic and pro-resolving effects
Poster Number: PA896
Abstract Number: 62491
Session: 12.04 – Rare ILD/DPLD
Presenter: Marc Hertz, PhD, Chief Executive Officer of GRI Bio
Date and Time: Sunday, September 6, 2026, from 8:00–9:30 AM CEST
Safety
Title: GRI-0621 phase 2a biomarker study in patients with IPF: a safety signal demonstrating favorable tolerability
Poster Number: PA895
Abstract Number: 62486
Session: 12.04 – Rare ILD/DPLD
Presenter: Helen Parfrey, MA PhD FRCP
Date and Time: Sunday, September 6, 2026, from 8:00–9:30 AM CEST
For more information about the 2026 European Respiratory Society Congress, please visit the conference website.
About GRI Bio, Inc.
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.
In addition to GRI-0621, the Company is also developing a pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies, topline or interim data or trials will be indicative of results of later studies or clinical trials or final data, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected future milestones, shareholder value and the length of time the Company’s current resources will fund its planned operations (which current estimate assumes only initial preparatory activities for GRI-0621 as substantial additional capital or resources will be required to fund future clinical trials of GRI-0621). Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation risks related to: (1) the Company’s inability to maintain the listing of the Company’s common stock on The Nasdaq Capital Market and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the accuracy of the estimated size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; (9) that later data or clinical trials may be inconsistent with or contrary to data and observations to date, including that later data may not indicate a patient benefit, modulate toxicities or validate a mechanism of action; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents and its ability to obtain any expected patent term extensions, adjustments, exclusivities or disclaimers; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-K filed with the SEC on January 30, 2026 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
GRI@jtcir.com
