Palisade Bio Receives FDA Clearance for PALI-2108 to Enter Phase 2 Trials
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 29 2026
0mins
Palisade Bio announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for its oral drug candidate, PALI-2108. The clearance allows the company to initiate its global Phase 2 ASCENTRA-UC study evaluating PALI-2108 in patients with moderately to severely active ulcerative colitis. The trial is expected to enroll up to 204 patients across North America and Europe. Palisade expects to begin patient enrollment in the second half of 2026 and report primary efficacy results in the second half of 2027. "FDA clearance of our IND application is a significant milestone for Palisade Bio and an important validation of the extensive preclinical, manufacturing and clinical work completed to advance PALI-2108 into Phase 2 development," said Mitch Jones, president and chief medical officer of Palisade Bio.
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Analyst Views on PALI
Wall Street analysts forecast PALI stock price to rise
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Strong Buy
Current: 2.040
Low
7.00
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13.00
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25.00
Current: 2.040
Low
7.00
Averages
13.00
High
25.00
About PALI
Palisade Bio, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing and advancing therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company’s lead product candidate, PALI-2108, is being developed as a treatment for patients living with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Fibrostenotic Crohn’s disease (FSCD). The Company is conducting a Phase I human clinical trial of its lead product candidate, PALI-2108, for the treatment of UC. In UC mouse models, the Company has demonstrated the dose-dependent efficacy of PALI-2108. It utilizes dextran sodium sulfate (DSS)-induced UC mouse models and targets engagement in oxazolone-induced colitis. PALI-2108 targets the key phosphodiesterase-4 (PDE4) in colon tissues and prevents it from breaking down cyclic Adenosine Monophosphate (cAMP) molecules which regulate inflammation in the body.
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.
Palisade Bio Receives FDA Approval for Clinical Trial
- FDA Approval for Trials: Palisade Bio received FDA clearance to initiate the global Phase 2 Ascentra-UC study targeting moderately to severely active ulcerative colitis patients, with plans to enroll 204 participants, highlighting the company's advancements in chronic bowel disease research.
- Significant Stock Surge: Following the FDA approval announcement, Palisade Bio's shares surged over 17%, marking the largest single-day gain in seven months and reaching their highest levels in nearly two months, reflecting strong market confidence in the new drug.
- Increased R&D Expenses: The company's Q1 report indicated that research and development expenses for PALI-2108 rose significantly from $1 million to $6.4 million year-over-year, demonstrating a heightened investment in clinical trials that is expected to support key data readouts for ulcerative colitis in 2027 and Crohn's disease in early 2028.
- Optimistic Market Sentiment: Following the FDA approval, retail sentiment for Palisade Bio on Stocktwits shifted from 'bullish' to 'extremely bullish', with users anticipating the stock could exceed $3, despite a 12% decline this year, indicating a notable increase in positive market expectations for the future.
See More
Palisade Bio Receives FDA Clearance for Clinical Trial Initiation
- FDA IND Approval: Palisade Bio's PALI-2108 has received FDA clearance for its Investigational New Drug application to treat moderately to severely active ulcerative colitis, enabling the initiation of the global Phase 2 ASCENTRA-UC clinical trial, marking a significant milestone in its development process.
- Trial Design: The ASCENTRA-UC will be a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial designed to enroll up to 204 patients, evaluating the efficacy, safety, and pharmacokinetics of PALI-2108, which is expected to provide critical data for future treatment options.
- Key Milestones: The first patient enrollment is anticipated in the second half of 2026, with primary efficacy results expected in the second half of 2027, establishing a timeline that will support Palisade Bio's further development in the ulcerative colitis space.
- Future Development Plans: In addition to ASCENTRA-UC, Palisade Bio plans to submit an IND application for Crohn's disease in the second half of 2026, demonstrating the company's ongoing commitment and strategic positioning in the treatment of gastrointestinal diseases.
See More
Palisade Bio Receives FDA Approval for UC Clinical Trial
- Clinical Trial Launch: Palisade Bio announced that its IND application for PALI-2108 has been cleared by the FDA, with patient enrollment for the ASCENTRA-UC trial expected to begin in the second half of 2026, marking a significant advancement in the company's inflammatory bowel disease portfolio.
- Trial Design Highlights: The ASCENTRA-UC trial will utilize a randomized, double-blind, placebo-controlled design, primarily assessing clinical remission at 12 weeks, indicating PALI-2108's potential in treating ulcerative colitis and offering new therapeutic options for patients.
- Partnership Strategy: To ensure the successful execution of ASCENTRA-UC, Palisade Bio has partnered with PSI, a leading global contract research organization, leveraging its extensive experience in immunology and gastroenterology to enhance the likelihood of clinical trial success.
- Future Development Plans: Palisade Bio also plans to submit an IND application for ASCENTRA-CD in the second half of 2026, demonstrating the company's confidence in expanding PALI-2108's applications across inflammatory bowel disease indications, potentially opening up broader market opportunities.
See More
B Group Acquires Stake in Bright Minds Biosciences
- New Investment Position: B Group disclosed in its May 15, 2026 SEC filing that it acquired 67,500 shares of Bright Minds Biosciences for an estimated $5.43 million, indicating confidence in the company's future growth potential.
- Significant Stake: This acquisition represents approximately 4% of B Group's reportable AUM, reflecting its strategic positioning within the biotechnology sector.
- Strong Market Performance: Bright Minds' shares have surged nearly 175% over the past year, significantly outperforming the S&P 500's 25% increase, highlighting market confidence in its drug development prospects.
- Increased R&D Investment: Bright Minds ramped up its R&D spending to C$18.7 million in the first half of fiscal 2026, a substantial increase from C$3.6 million a year earlier, demonstrating accelerated efforts in developing its lead drug BMB-101 for drug-resistant epilepsy.
See More
Palisade Bio Schedules Virtual Presentation at Needham Healthcare Conference
- Virtual Presentation Scheduled: Palisade Bio will present virtually at the Needham & Co. 25th Annual Healthcare Conference on April 16, 2026, from 2:15 PM to 2:55 PM ET, showcasing its innovative drug development in inflammatory and fibrotic diseases.
- Management Engagement: CEO JD Finley and CMO Dr. Mitchell Jones will participate in the conference, engaging in one-on-one meetings with registered investors post-presentation, enhancing transparency and interaction with the investment community.
- Product Development Progress: The company's lead program, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed for selective bioactivation in the ileum and colon, enabling targeted inhibition at disease sites while improving patient convenience and tolerability.
- Clinical Study Plans: Palisade is advancing towards a Phase 2 clinical study in ulcerative colitis, aimed at evaluating clinical remission, response, and pharmacodynamic biomarkers over 12 weeks, with an extension phase to assess maintenance of remission, highlighting its potential in chronic disease treatment.
See More
Palisade Bio Reports Early Trial Data for PALI-2108 in Crohn’s Disease
- Clinical Trial Progress: Palisade Bio reported two weeks of data from its early-stage trial of PALI-2108 for fibrostenotic Crohn’s disease, indicating endoscopic response rates comparable to AbbVie's Skyrizi and Rinvoq, highlighting its therapeutic potential.
- Safety Profile: The therapy showed no serious adverse events among five patients, and the experimental treatment was well tolerated, demonstrating its safety for clinical application.
- Follow-up Research Plans: Palisade Bio intends to launch a Phase 2 study to further evaluate PALI-2108's efficacy in moderate to severe Crohn’s disease patients, reflecting the company's confidence in the drug's future market potential.
- Market Outlook: Palisade Bio is viewed as an undervalued biotech firm with blockbuster drug development potential, leading to optimistic market sentiment regarding its future performance.
See More
Palisade Bio Receives FDA Approval for Clinical Trial
- FDA Approval for Trials: Palisade Bio received FDA clearance to initiate the global Phase 2 Ascentra-UC study targeting moderately to severely active ulcerative colitis patients, with plans to enroll 204 participants, highlighting the company's advancements in chronic bowel disease research.
- Significant Stock Surge: Following the FDA approval announcement, Palisade Bio's shares surged over 17%, marking the largest single-day gain in seven months and reaching their highest levels in nearly two months, reflecting strong market confidence in the new drug.
- Increased R&D Expenses: The company's Q1 report indicated that research and development expenses for PALI-2108 rose significantly from $1 million to $6.4 million year-over-year, demonstrating a heightened investment in clinical trials that is expected to support key data readouts for ulcerative colitis in 2027 and Crohn's disease in early 2028.
- Optimistic Market Sentiment: Following the FDA approval, retail sentiment for Palisade Bio on Stocktwits shifted from 'bullish' to 'extremely bullish', with users anticipating the stock could exceed $3, despite a 12% decline this year, indicating a notable increase in positive market expectations for the future.
See More
Palisade Bio Receives FDA Clearance for Clinical Trial Initiation
- FDA IND Approval: Palisade Bio's PALI-2108 has received FDA clearance for its Investigational New Drug application to treat moderately to severely active ulcerative colitis, enabling the initiation of the global Phase 2 ASCENTRA-UC clinical trial, marking a significant milestone in its development process.
- Trial Design: The ASCENTRA-UC will be a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial designed to enroll up to 204 patients, evaluating the efficacy, safety, and pharmacokinetics of PALI-2108, which is expected to provide critical data for future treatment options.
- Key Milestones: The first patient enrollment is anticipated in the second half of 2026, with primary efficacy results expected in the second half of 2027, establishing a timeline that will support Palisade Bio's further development in the ulcerative colitis space.
- Future Development Plans: In addition to ASCENTRA-UC, Palisade Bio plans to submit an IND application for Crohn's disease in the second half of 2026, demonstrating the company's ongoing commitment and strategic positioning in the treatment of gastrointestinal diseases.
See More
Palisade Bio Receives FDA Approval for UC Clinical Trial
- Clinical Trial Launch: Palisade Bio announced that its IND application for PALI-2108 has been cleared by the FDA, with patient enrollment for the ASCENTRA-UC trial expected to begin in the second half of 2026, marking a significant advancement in the company's inflammatory bowel disease portfolio.
- Trial Design Highlights: The ASCENTRA-UC trial will utilize a randomized, double-blind, placebo-controlled design, primarily assessing clinical remission at 12 weeks, indicating PALI-2108's potential in treating ulcerative colitis and offering new therapeutic options for patients.
- Partnership Strategy: To ensure the successful execution of ASCENTRA-UC, Palisade Bio has partnered with PSI, a leading global contract research organization, leveraging its extensive experience in immunology and gastroenterology to enhance the likelihood of clinical trial success.
- Future Development Plans: Palisade Bio also plans to submit an IND application for ASCENTRA-CD in the second half of 2026, demonstrating the company's confidence in expanding PALI-2108's applications across inflammatory bowel disease indications, potentially opening up broader market opportunities.
See More
B Group Acquires Stake in Bright Minds Biosciences
- New Investment Position: B Group disclosed in its May 15, 2026 SEC filing that it acquired 67,500 shares of Bright Minds Biosciences for an estimated $5.43 million, indicating confidence in the company's future growth potential.
- Significant Stake: This acquisition represents approximately 4% of B Group's reportable AUM, reflecting its strategic positioning within the biotechnology sector.
- Strong Market Performance: Bright Minds' shares have surged nearly 175% over the past year, significantly outperforming the S&P 500's 25% increase, highlighting market confidence in its drug development prospects.
- Increased R&D Investment: Bright Minds ramped up its R&D spending to C$18.7 million in the first half of fiscal 2026, a substantial increase from C$3.6 million a year earlier, demonstrating accelerated efforts in developing its lead drug BMB-101 for drug-resistant epilepsy.
See More
Palisade Bio Schedules Virtual Presentation at Needham Healthcare Conference
- Virtual Presentation Scheduled: Palisade Bio will present virtually at the Needham & Co. 25th Annual Healthcare Conference on April 16, 2026, from 2:15 PM to 2:55 PM ET, showcasing its innovative drug development in inflammatory and fibrotic diseases.
- Management Engagement: CEO JD Finley and CMO Dr. Mitchell Jones will participate in the conference, engaging in one-on-one meetings with registered investors post-presentation, enhancing transparency and interaction with the investment community.
- Product Development Progress: The company's lead program, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed for selective bioactivation in the ileum and colon, enabling targeted inhibition at disease sites while improving patient convenience and tolerability.
- Clinical Study Plans: Palisade is advancing towards a Phase 2 clinical study in ulcerative colitis, aimed at evaluating clinical remission, response, and pharmacodynamic biomarkers over 12 weeks, with an extension phase to assess maintenance of remission, highlighting its potential in chronic disease treatment.
See More
Palisade Bio Reports Early Trial Data for PALI-2108 in Crohn’s Disease
- Clinical Trial Progress: Palisade Bio reported two weeks of data from its early-stage trial of PALI-2108 for fibrostenotic Crohn’s disease, indicating endoscopic response rates comparable to AbbVie's Skyrizi and Rinvoq, highlighting its therapeutic potential.
- Safety Profile: The therapy showed no serious adverse events among five patients, and the experimental treatment was well tolerated, demonstrating its safety for clinical application.
- Follow-up Research Plans: Palisade Bio intends to launch a Phase 2 study to further evaluate PALI-2108's efficacy in moderate to severe Crohn’s disease patients, reflecting the company's confidence in the drug's future market potential.
- Market Outlook: Palisade Bio is viewed as an undervalued biotech firm with blockbuster drug development potential, leading to optimistic market sentiment regarding its future performance.
See More
