Palisade Bio, Inc. develops next-generation oral PDE4 inhibitor prodrugs for inflammatory and fibrotic diseases. Its lead program, PALI-2108, is a once-daily oral PDE4 inhibitor prodrug designed for targeted delivery and selective bioactivation in the ileum and colon, with clinical development focused on ulcerative colitis and Crohn’s disease.
Company news commonly covers PALI-2108 clinical and translational data, pharmacokinetic and biomarker findings, disease-conference presentations, clinical advisory activity and healthcare investor events. Updates also describe the company’s precision pharmacology strategy and the role of gut-targeted PDE4 inhibition in inflammatory bowel disease programs.
Palisade Bio (Nasdaq: PALI) announced first patients dosed in its open-label Phase 1b study of PALI-2108, an ileocolonic-targeted PDE4 inhibitor prodrug for fibrostenotic Crohn’s disease (FSCD), on Oct 20, 2025. The study will enroll ~6–12 patients to evaluate safety, tolerability, PK, PD, tissue pharmacology, and molecular responses over a 14-day dosing period. Topline safety, PK, and PD data are anticipated in Q1 2026. Data plus existing UC program results are planned to support a Phase 2 IND submission in H1 2026.
Palisade Bio (Nasdaq: PALI) announced that the Canadian Intellectual Property Office granted patent No. 3,174,137 for PALI-2108, titled “Gut Microbiota Bioactivated PDE4 Inhibitor Precursors,” providing composition-of-matter protection through May 28, 2041. PALI-2108 is an orally administered, ileocolonic-targeted PDE4 B/D inhibitor designed for fibrostenotic Crohn’s disease (FSCD) and ulcerative colitis (UC). The molecule uses a galactose-derived sugar moiety activated by colonic β-glucuronidase to enable colon-specific distribution with reduced systemic exposure, as shown in a tissue distribution study. Patient dosing in the Phase 1b FSCD study was expected in H2 2025, topline data expected in Q1 2026, and a planned Phase 2 IND submission to FDA is targeted for H1 2026.
Palisade Bio (Nasdaq: PALI) announced on October 9, 2025 that it has cancelled its previously adjourned special meeting of stockholders that had been scheduled to reconvene on October 10, 2025. The meeting was earlier reconvened on September 26, 2025 but adjourned without business due to a lack of quorum.
The company said it still has not received sufficient proxies to constitute a quorum and has withdrawn from stockholder consideration the proposals included in its definitive proxy statement filed with the SEC on August 18, 2025.
Palisade Bio (Nasdaq: PALI) announced closing an upsized public offering on October 2, 2025 that raised approximately $138 million in gross proceeds, including full exercise of the underwriter’s over-allotment option. The offering comprised 197,154,844 shares at a public offering price of $0.70 per share. Proceeds will support the upcoming Phase 2 clinical program for PALI-2108 in ulcerative colitis. Ladenburg Thalmann served as sole book-running manager. SEC registration statements (Form S-1 File Nos. 333-290568 and 333-290644) were effective Sept 30 and Oct 1, 2025.
Palisade Bio (NASDAQ: PALI), a clinical-stage biopharmaceutical company, has announced the pricing of an upsized $120 million underwritten public offering. The offering consists of 171,440,559 shares of common stock priced at $0.70 per share.
The company has granted underwriters a 45-day option to purchase up to an additional 25,714,285 shares at the public offering price. Ladenburg Thalmann & Co. Inc. is serving as the sole book-running manager. The offering is expected to close around October 2, 2025, subject to customary closing conditions.
Palisade Bio (NASDAQ: PALI), a clinical-stage biopharmaceutical company, announced the adjournment of its special meeting of stockholders on September 26, 2025, due to insufficient quorum. The meeting required one-third of outstanding shares present but achieved only 29.68% participation.
The meeting has been rescheduled for October 10, 2025 at 10:00 a.m. Pacific Time in virtual format. Only stockholders of record as of July 28, 2025 are eligible to vote. The company has engaged Mediant Communications Inc. to assist in obtaining the required votes, with a voting deadline of October 9, 2025, at 11:59 p.m. Pacific Time.
Palisade Bio (Nasdaq: PALI), a clinical-stage biopharmaceutical company, announced the adjournment of its special stockholders meeting on September 18, 2025 due to insufficient quorum. The meeting achieved only 28.34% participation of eligible voting shares, falling short of the required one-third quorum threshold.
The meeting has been rescheduled for September 26, 2025 at 10:00 a.m. Pacific Time in virtual format. Only stockholders of record as of July 28, 2025 are eligible to vote. The company has engaged Mediant Communications Inc. to assist in obtaining adequate votes, with a voting deadline of September 25, 2025 at 11:59 p.m. Pacific Time.
Palisade Bio (NASDAQ:PALI) has reported positive Phase 1b clinical data for PALI-2108, its first-in-class, ileocolonic-targeted PDE4 B/D inhibitor for autoimmune and inflammatory diseases. The trial demonstrated 100% clinical response in ulcerative colitis (UC) patients, with 2 out of 5 patients achieving remission after just seven days.
Key findings include no serious adverse events in Phase 1a trials (n=84), and significant improvements in Phase 1b UC cohort (n=5) including a 62.8% mean reduction in modified Mayo score and approximately 70% reduction in fecal calprotectin. The study also showed normalization of 186 genes linked to fibrosis, supporting potential application in fibrostenotic Crohn's disease (FSCD).
The company plans to begin patient dosing for the Phase 1b FSCD study in 2H 2025, with Phase 2 IND submissions anticipated in 1H 2026.
Palisade Bio (NASDAQ:PALI) has received Health Canada clearance for a Phase 1b clinical trial of PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor for treating fibrostenotic Crohn's disease (FSCD). The trial will enroll 6-12 patients to evaluate safety, pharmacokinetics, and pharmacodynamics.
PALI-2108 represents the first dual-acting anti-inflammatory and anti-fibrotic candidate for FSCD, a condition affecting up to half of Crohn's disease patients with no currently approved therapies. Patient dosing is expected to begin in H2 2025, with topline data anticipated in Q1 2026. The company plans to submit a Phase 2 IND to the FDA in H1 2026.
Palisade Bio (NASDAQ:PALI) has released a Virtual Investor KOL Connect segment featuring Dr. Brian G. Feagan, a leading expert in Fibrostenotic Crohn's Disease (FSCD) and Inflammatory Bowel Diseases (IBD). The segment focuses on the company's lead candidate PALI-2108 and its potential impact on FSCD treatment.
Dr. Feagan, a Professor of Medicine at Western University and Senior Scientific Director at Alimentiv, Inc., discussed the significant unmet need in FSCD treatment and highlighted PALI-2108's novel approach. The drug candidate is designed to provide localized treatment that reduces side effects while maintaining anti-inflammatory and anti-fibrotic activity.