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GRI Bio reports Phase 2a data on GRI-0621 for lung fibrosis

Tue, 08 Sep 2026 08:15:23 -0400

GRI Bio, Inc. (NASDAQ: GRI) presented new translational biomarker data from its Phase 2a study of GRI-0621, an oral retinoic acid receptor β/γ-selective agonist, in patients with idiopathic pulmonary fibrosis (IPF), at the 2026 European Respiratory Society Congress in Barcelona, Spain.

The data, drawn from a 35-patient randomized, double-blind, placebo-controlled study, integrated four independent measurement modalities: whole-blood RNA sequencing, a 12-marker serum extracellular matrix biomarker panel, 28-color spectral flow cytometry, and clinical readouts. The company said direction-consistent signals across these modalities supported nine pre-specified mechanistic pillars, including immune re-balancing, myofibroblast inhibition, fibrolysis, basement-membrane repair, and re-epithelialization.

Patients were randomized 2:1 to receive

GRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621's Mechanism of Action in IPF Across Nine Mechanistic Pillars

Tue, 08 Sep 2026 08:15:00 -0400

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

GRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621's Mechanism of Action in IPF Across Nine Mechanistic Pillars

Tue, 08 Sep 2026 08:15:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio Featured in "Why Now" On-Demand Video Webcast

Thu, 27 Aug 2026 09:01:00 -0400

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

GRI Bio to present Phase 2a IPF drug data at ERS Congress in September

Mon, 24 Aug 2026 09:05:16 -0400

GRI Bio, Inc. (NASDAQ: GRI) announced that three abstracts and an oral presentation from its Phase 2a GRI-0621-IPF-02 study have been selected for the 2026 European Respiratory Society (ERS) Congress, scheduled for September 5–9 in Barcelona, Spain.

The presentations cover data on GRI-0621, an oral retinoic acid receptor (RAR) β/γ-selective agonist the company is developing for idiopathic pulmonary fibrosis (IPF). The data spans safety and tolerability, translational biomarkers, and lung function outcomes.

A late-breaking oral presentation, titled "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," is

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

Mon, 24 Aug 2026 09:05:00 -0400

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

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

Mon, 24 Aug 2026 09:05:00 -0400

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

Form 10-Q GRI Bio, Inc. For: Jun 30

Fri, 14 Aug 2026 07:45:00 -0400
si-local-file:///var/storage/secattach/20260814/26924641.html

Form 10-Q GRI Bio, Inc. For: Jun 30

Fri, 14 Aug 2026 07:45:00 -0400
si-local-file:///var/storage/secattach/20260814/26924641.html

Form SCHEDULE 13G/A GRI Bio, Inc. Filed by: INTRACOASTAL CAPITAL, LLC

Thu, 13 Aug 2026 10:17:00 -0400
si-local-file:///var/storage/secattach/20260813/26918105.html

Form SCHEDULE 13G/A GRI Bio, Inc. Filed by: INTRACOASTAL CAPITAL, LLC

Thu, 13 Aug 2026 10:17:00 -0400
si-local-file:///var/storage/secattach/20260813/26918105.html

Form 8-K GRI Bio, Inc. For: Jun 18

Thu, 18 Jun 2026 16:51:00 -0400
si-local-file:///var/storage/secattach/20260618/26666871.html

Form 8-K GRI Bio, Inc. For: Jun 18

Thu, 18 Jun 2026 16:51:00 -0400
si-local-file:///var/storage/secattach/20260618/26666871.html

FDA grants orphan drug status to GRI Bio's GRI-0621 for lung disease

Thu, 18 Jun 2026 08:32:45 -0400

GRI Bio, Inc. (NASDAQ: GRI) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its investigational therapy GRI-0621 for the treatment of idiopathic pulmonary fibrosis, a progressive and fatal lung disease.
Orphan Drug Designation is awarded to therapies targeting rare diseases that affect fewer than 200,000 people in the United States. The designation provides potential benefits including seven years of U.S. market exclusivity upon approval, tax credits for qualified clinical development expenses, waiver of certain FDA application fees, and enhanced regulatory engagement during development.
GRI-0621 is an oral, once-daily RARβ/γ-selective agonist designed to modulate pathways involved in

FDA grants orphan drug status to GRI Bio's GRI-0621 for lung disease

Thu, 18 Jun 2026 08:32:45 -0400

GRI Bio, Inc. (NASDAQ: GRI) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its investigational therapy GRI-0621 for the treatment of idiopathic pulmonary fibrosis, a progressive and fatal lung disease.
Orphan Drug Designation is awarded to therapies targeting rare diseases that affect fewer than 200,000 people in the United States. The designation provides potential benefits including seven years of U.S. market exclusivity upon approval, tax credits for qualified clinical development expenses, waiver of certain FDA application fees, and enhanced regulatory engagement during development.
GRI-0621 is an oral, once-daily RARβ/γ-selective agonist designed to modulate pathways involved in

GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis

Thu, 18 Jun 2026 08:31:00 -0400

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.

GRI Bio Secures FDA Orphan Drug Designation for GRI-0621 (Tazarotene) in Idiopathic Pulmonary Fibrosis

Thu, 18 Jun 2026 08:31:00 -0400

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.

GRI Bio to Present at A.G.P.’s Annual Healthcare Company Showcase

Mon, 18 May 2026 09:15:00 -0400

Live webcast fireside chat with Marc Hertz, PhD, Chief Executive Officer, on Wednesday, May 20, 2026

Register for the event here

LA JOLLA, CA, May 18, 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 Marc Hertz, PhD, Chief Executive Officer of GRI Bio, will participate in a fireside chat at

GRI Bio to Present at A.G.P.’s Annual Healthcare Company Showcase

Mon, 18 May 2026 09:15:00 -0400

Live webcast fireside chat with Marc Hertz, PhD, Chief Executive Officer, on Wednesday, May 20, 2026

Register for the event here

LA JOLLA, CA, May 18, 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 Marc Hertz, PhD, Chief Executive Officer of GRI Bio, will participate in a fireside chat at

GRI Bio to Present at A.G.P.’s Annual Healthcare Company Showcase

Mon, 18 May 2026 09:15:00 -0400

Live webcast fireside chat with Marc Hertz, PhD, Chief Executive Officer, on Wednesday, May 20, 2026

Register for the event here

LA JOLLA, CA, May 18, 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 Marc Hertz, PhD, Chief Executive Officer of GRI Bio, will participate in a fireside chat at