GRI Bio Reports Positive Phase 2a Results for GRI-0621 with No Serious Adverse Events Over 12 Weeks
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 10 2025
0mins
Should l Buy GRI?
Source: Globenewswire
- Safety Validation: GRI-0621 demonstrated no drug-related severe adverse events over the 12-week treatment period, with no increase in gastrointestinal issues compared to existing therapies, indicating a favorable safety profile that may offer a safer treatment option for IPF patients.
- Biomarker Improvement: The treatment group showed improvements in collagen turnover biomarkers, with PRO-C6 decreasing by 3% in the GRI-0621 group while increasing by 12% in the placebo group, suggesting GRI-0621's potential to reverse fibrosis and promote lung tissue repair.
- Lung Capacity Enhancement: At 12 weeks, 39% of patients treated with GRI-0621 experienced an increase in forced vital capacity (FVC), while 80% of the placebo group saw a decline, highlighting GRI-0621's potential to improve lung function and possibly transform the treatment landscape for IPF.
- Clinical Trial Milestone: The trial results establish a significant milestone for GRI Bio's IPF program, with the CEO stating that GRI-0621 could surpass current treatments by directly impacting the underlying pathology of IPF, potentially creating substantial value for both patients and shareholders.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy GRI?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on GRI
Wall Street analysts forecast GRI stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.250
Low
10.00
Averages
23.00
High
36.00
Current: 2.250
Low
10.00
Averages
23.00
High
36.00
About GRI
GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. The Company’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. Its lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis. The Company is also developing a pipeline of novel type II diverse NKT agonists for the treatment of systemic lupus erythematosus. Its product candidate portfolio also includes GRI-0803 and a proprietary library of more than 500 compounds. It is developing GRI-0803 for the treatment of autoimmune disorders, with much of its preclinical work in systemic lupus erythematosus disease (SLE) and multiple sclerosis (MS).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
GRI Bio to Participate in Webull Webinar Series
- Webinar Participation: GRI Bio will participate in a Corporate Connect Webinar hosted by Webull Financial on February 11, 2026, at 1:00 PM EST, showcasing its innovative pipeline of immune cell modulators, which aims to enhance the company's visibility and investor confidence in the biotechnology sector.
- Leadership Presentation: CEO Marc Hertz, PhD, will present the latest advancements in GRI Bio's treatments for inflammatory, fibrotic, and autoimmune diseases, which is expected to attract potential investors' attention and bolster market trust.
- Pipeline Highlights: GRI Bio's lead program, GRI-0621, an RARβγ agonist, is being developed for idiopathic pulmonary fibrosis, a serious disease with significant unmet needs, and successful commercialization could substantially increase the company's revenue and market share.
- Future Outlook: The company is also developing a range of novel NKT agonists targeting systemic lupus erythematosus, and as its product pipeline expands, GRI Bio is positioned to capture a larger market share in the biopharmaceutical industry, driving long-term growth.
See More
GRI Biopress Reports $12 Million Net Loss for FY 2025
- Annual Financial Performance: GRI Biopress reported a net loss of $12 million for the fiscal year ending December 31, 2025, indicating significant challenges in profitability that could impact future investor confidence.
- Cash Flow Status: As of December 31, 2025, the company had $8.2 million in cash and cash equivalents, reflecting tight liquidity that may limit its operational and expansion capabilities.
- Financing Activity: In January 2026, GRI Biopress raised $6.5 million in gross proceeds, which, while alleviating short-term funding pressures, necessitates ongoing scrutiny of its long-term financial health.
- Public Offering Plans: GRI Biopress announced an $8 million public offering aimed at raising additional capital to support business development, although market reactions may be influenced by its financial performance.
See More
GRI Bio Reports Promising Phase 2a Results for GRI-0621
- Clinical Trial Results: GRI Bio announced that GRI-0621 significantly modulated genes related to lung injury and fibrosis progression in its Phase 2a study for Idiopathic Pulmonary Fibrosis, suggesting the drug may alter disease trajectory.
- Safety and Tolerability: Prior Phase 2a results indicated favorable safety and tolerability, with treated patients maintaining lung function at twice the rate of standard care, highlighting the potential clinical value of GRI-0621.
- Market Reaction: Despite the encouraging new data, GRI shares fell 20%, leading to speculation about short selling; however, retail sentiment on Stocktwits shifted to 'extremely bullish', reflecting confidence in the drug's prospects.
- Reverse Split: Last week, GRI Bio announced a 1-for-28 reverse stock split to comply with Nasdaq's minimum bid price requirement, reducing outstanding shares from approximately 15 million to 536,000, aimed at boosting the stock price for continued listing.
See More
GRI BIO INC - GRI-0621 Demonstrates Notable Genetic Enhancement in Lung Injury
Significant Gene Improvement: Recent advancements have been made in gene therapy that show promise for treating lung injuries.
Potential Impact on Treatment: These improvements could lead to more effective treatments for patients suffering from lung-related conditions.
See More
GRI BIO INC REPORTS ENCOURAGING PHASE 2A RESULTS FOR GRI-0621 IN IPF
Announcement of Phase 2 Data: Gribio Inc. has announced positive Phase 2 data for its drug candidate, GRI-0621.
Significance of Results: The results indicate promising efficacy and safety profiles, which could advance the drug towards further clinical development.
See More
GRI Bio Secures New Patent Protection
- Patent Protection Enhanced: GRI Bio has secured U.S. Patent No. 12,528,775, providing robust intellectual property protection for novel compounds with broad therapeutic potential in treating inflammatory, fibrotic, and autoimmune diseases, thereby enhancing the company's market competitiveness.
- Molecular Design Innovation: The new patent covers compounds with unique molecular structures, including pyrrolidine, piperidine, or azepane ring systems, representing a significant structural advancement distinct from previously issued patents, further solidifying GRI Bio's intellectual property portfolio.
- Product Development Strategy: GRI Bio is focused on advancing its lead program, GRI-0621, an RARβγ agonist aimed at treating idiopathic pulmonary fibrosis, addressing the urgent market need for new therapies while leveraging a library of over 500 proprietary compounds to support future pipeline expansion.
- Clear Market Positioning: By enhancing modulation of Natural Killer T (NKT) cell biology, GRI Bio's technology platform not only improves therapeutic outcomes but also lays the groundwork for potential strategic partnerships, further driving the company's growth in the biopharmaceutical sector.
See More
GRI Bio to Participate in Webull Webinar Series
- Webinar Participation: GRI Bio will participate in a Corporate Connect Webinar hosted by Webull Financial on February 11, 2026, at 1:00 PM EST, showcasing its innovative pipeline of immune cell modulators, which aims to enhance the company's visibility and investor confidence in the biotechnology sector.
- Leadership Presentation: CEO Marc Hertz, PhD, will present the latest advancements in GRI Bio's treatments for inflammatory, fibrotic, and autoimmune diseases, which is expected to attract potential investors' attention and bolster market trust.
- Pipeline Highlights: GRI Bio's lead program, GRI-0621, an RARβγ agonist, is being developed for idiopathic pulmonary fibrosis, a serious disease with significant unmet needs, and successful commercialization could substantially increase the company's revenue and market share.
- Future Outlook: The company is also developing a range of novel NKT agonists targeting systemic lupus erythematosus, and as its product pipeline expands, GRI Bio is positioned to capture a larger market share in the biopharmaceutical industry, driving long-term growth.
See More
GRI Biopress Reports $12 Million Net Loss for FY 2025
- Annual Financial Performance: GRI Biopress reported a net loss of $12 million for the fiscal year ending December 31, 2025, indicating significant challenges in profitability that could impact future investor confidence.
- Cash Flow Status: As of December 31, 2025, the company had $8.2 million in cash and cash equivalents, reflecting tight liquidity that may limit its operational and expansion capabilities.
- Financing Activity: In January 2026, GRI Biopress raised $6.5 million in gross proceeds, which, while alleviating short-term funding pressures, necessitates ongoing scrutiny of its long-term financial health.
- Public Offering Plans: GRI Biopress announced an $8 million public offering aimed at raising additional capital to support business development, although market reactions may be influenced by its financial performance.
See More
GRI Bio Reports Promising Phase 2a Results for GRI-0621
- Clinical Trial Results: GRI Bio announced that GRI-0621 significantly modulated genes related to lung injury and fibrosis progression in its Phase 2a study for Idiopathic Pulmonary Fibrosis, suggesting the drug may alter disease trajectory.
- Safety and Tolerability: Prior Phase 2a results indicated favorable safety and tolerability, with treated patients maintaining lung function at twice the rate of standard care, highlighting the potential clinical value of GRI-0621.
- Market Reaction: Despite the encouraging new data, GRI shares fell 20%, leading to speculation about short selling; however, retail sentiment on Stocktwits shifted to 'extremely bullish', reflecting confidence in the drug's prospects.
- Reverse Split: Last week, GRI Bio announced a 1-for-28 reverse stock split to comply with Nasdaq's minimum bid price requirement, reducing outstanding shares from approximately 15 million to 536,000, aimed at boosting the stock price for continued listing.
See More
GRI BIO INC - GRI-0621 Demonstrates Notable Genetic Enhancement in Lung Injury
Significant Gene Improvement: Recent advancements have been made in gene therapy that show promise for treating lung injuries.
Potential Impact on Treatment: These improvements could lead to more effective treatments for patients suffering from lung-related conditions.
See More
GRI BIO INC REPORTS ENCOURAGING PHASE 2A RESULTS FOR GRI-0621 IN IPF
Announcement of Phase 2 Data: Gribio Inc. has announced positive Phase 2 data for its drug candidate, GRI-0621.
Significance of Results: The results indicate promising efficacy and safety profiles, which could advance the drug towards further clinical development.
See More
GRI Bio Secures New Patent Protection
- Patent Protection Enhanced: GRI Bio has secured U.S. Patent No. 12,528,775, providing robust intellectual property protection for novel compounds with broad therapeutic potential in treating inflammatory, fibrotic, and autoimmune diseases, thereby enhancing the company's market competitiveness.
- Molecular Design Innovation: The new patent covers compounds with unique molecular structures, including pyrrolidine, piperidine, or azepane ring systems, representing a significant structural advancement distinct from previously issued patents, further solidifying GRI Bio's intellectual property portfolio.
- Product Development Strategy: GRI Bio is focused on advancing its lead program, GRI-0621, an RARβγ agonist aimed at treating idiopathic pulmonary fibrosis, addressing the urgent market need for new therapies while leveraging a library of over 500 proprietary compounds to support future pipeline expansion.
- Clear Market Positioning: By enhancing modulation of Natural Killer T (NKT) cell biology, GRI Bio's technology platform not only improves therapeutic outcomes but also lays the groundwork for potential strategic partnerships, further driving the company's growth in the biopharmaceutical sector.
See More
