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) dosed the first patient in ASCENTRA-UC, its global Phase 2b ulcerative colitis trial of PALI-2108. The randomized, placebo-controlled study will evaluate two once-daily oral doses in approximately 204 patients with moderately to severely active disease. Its primary endpoint is clinical remission at Week 12; the company expects 12-week induction topline results in Q4 2027.
Palisade has activated 29 of 30 planned U.S. sites and is progressing toward approximately 115 sites globally. Canada has cleared the clinical trial application; submissions remain under review in Europe and other international countries. The completed Phase 1 program reported no serious adverse events. In a preliminary, uncontrolled Phase 1b cohort treated for seven days, all five evaluable patients achieved clinical response and two achieved remission based on the modified Mayo Score, a disease activity measure.
Palisade Bio (PALI) presented early PALI-2108 clinical results and intestinal tissue analyses in inflammatory bowel disease at UEG Week 2026. In five Phase 1b fibrostenotic Crohn’s disease patients, mean endoscopic disease activity fell 47.5% and mean fecal calprotectin, an intestinal inflammation marker, fell 58.8% after 14 days. Two patients achieved endoscopic response and two achieved endoscopic remission. All reported adverse events were mild.
In a separate five-patient ulcerative colitis cohort, all achieved clinical response and two achieved remission at Day 7. Tissue analyses showed biological activity. Both cohorts were small, short-duration and open-label, without placebo controls; results require confirmation and do not establish reversal of fibrosis. Palisade is enrolling the approximately 204-patient Phase 2b ASCENTRA-UC study and initiating an open-label Phase 2a Crohn’s disease study.
Palisade Bio (Nasdaq: PALI) presented early clinical and mechanistic PALI-2108 findings supporting its ongoing Phase 2 ulcerative colitis and Crohn’s disease development. PALI-2108 is an investigational oral prodrug activated in the intestine to inhibit PDE4, an enzyme involved in inflammatory signaling.
In five ulcerative colitis patients treated for seven days, all achieved clinical response and two achieved remission; modified Mayo scores fell a mean 62.8%. In five patients with fibrostenotic Crohn’s disease treated for 14 days, endoscopic scores fell a mean 47.5%; all reported adverse events were mild. Both cohorts were small, open-label and lacked placebo controls, requiring confirmation in larger studies. Tissue and drug-exposure analyses supported further development. The ongoing ASCENTRA-UC Phase 2 study evaluates once-daily 15 mg and 30 mg against placebo in approximately 204 patients.
Palisade Bio (PALI) will feature PALI-2108 clinical and translational findings in four presentations at UEG Week 2026.
An oral presentation will cover Phase 1b findings in fibrostenotic Crohn’s disease, including early endoscopic improvement and evidence of PDE4 target engagement. Three moderated posters will address gut-targeted drug exposure and safety and tolerability in inflammatory bowel disease, clinical response in ulcerative colitis within one week of treatment, and a biomarker being prospectively validated to predict treatment response in ulcerative colitis.
The conference runs October 17–20 in Barcelona. PALI-2108 is a once-daily oral treatment candidate being advanced into Phase 2 development in ulcerative colitis and Crohn’s disease. The announcement provides no patient counts or numerical efficacy results.
Palisade Bio (PALI) received Health Canada clearance for its Clinical Trial Application for ASCENTRA-UC, a global Phase 2b study of once-daily oral PALI-2108 in moderately to severely active ulcerative colitis.
The Canadian authorization allows site activation and patient enrollment in Canada and, together with prior U.S. clearance, supports the company’s global site activation and enrollment strategy. The randomized, double-blind, placebo-controlled, dose-ranging trial will enroll approximately 204 patients and evaluate 15 mg and 30 mg doses versus placebo. The 12-week induction period has a primary endpoint of clinical remission at Week 12 measured by modified Mayo Score, with key secondary endpoints including clinical response, endoscopic improvement and histologic-endoscopic mucosal improvement. A 36-week maintenance extension will assess durability of response and longer-term safety through Week 48. Patient dosing is expected to begin in the second half of 2026, with primary efficacy results expected in the second half of 2027.
Palisade Bio (PALI) received FDA clearance of its Investigational New Drug application for PALI-2108 in moderate to severe Crohn’s disease, enabling initiation of the Phase 2 ASCENTRA-CD trial.
ASCENTRA-CD is a multicenter, open-label, single-arm study in approximately 60 adults, with a 14-day dose titration to 30 mg once-daily oral PALI-2108, followed by a 12-week induction and 36-week maintenance phase. The primary endpoint is Week 12 endoscopic response, defined as at least a 50% reduction from baseline in SES-CD by blinded central review, with multiple clinical and endoscopic secondary endpoints through Week 48. First patient dosing is targeted for Q1 2027 and the primary efficacy readout for Q1 2028. The program builds on prior clinical experience in fibrostenotic Crohn’s disease and, together with the ASCENTRA-UC study, is intended to create a broader Phase 2 dataset across inflammatory bowel disease.
Palisade Bio (PALI)/b) will present at the Stifel 2026 Virtual Immunology and Inflammation Forum on September 23, 2026 at 1:00–1:25 PM ET.Chief Executive Officer JD Finley and President & Chief Medical Officer Mitchell Jones will give a virtual presentation updating the PALI-2108 clinical development program. Topics include recent progress in ulcerative colitis and Crohn’s disease, growing clinical and translational data supporting PALI-2108’s differentiated profile, and upcoming development milestones. A live webcast will be available via the Events page in the Investors section of palisadebio.com, with a replay accessible for a limited time. Management will also participate in one-on-one meetings with qualified, registered investors.
Palisade Bio (PALI) will participate in three healthcare investor conferences in September 2026, including events hosted by Wells Fargo, Morgan Stanley and H.C. Wainwright.
The Morgan Stanley fireside chat is on September 16, 2026, 10:00–10:35 AM ET in New York. The H.C. Wainwright presentation is on September 16, 2026, 3:00–3:30 PM ET in New York. Live webcasts and limited-time replays will be available on the Investors section of palisadebio.com.
Palisade Bio (Nasdaq: PALI) reported second quarter 2026 results and progress on its lead IBD candidate PALI-2108. The company is advancing PALI-2108 into Phase 2 ASCENTRA-UC and ASCENTRA-CD trials, with UC trial initiation expected in 2H 2026 and primary efficacy data in 2H 2027. An IND submission for the Crohn’s disease Phase 2 trial is targeted for 2H 2026, with trial start in 1Q 2027 and primary readout in early 2028.
PALI-2108’s Phase 1 data showed favorable safety, targeted gut distribution and clinical responses in small UC and fibrostenotic CD cohorts. For Q2 2026, Palisade Bio reported $0.5 million in license revenue, a net loss of $10.6 million ($0.05 per share), and $125.2 million in cash and cash equivalents, which the company believes can fund operations through these key Phase 2 readouts.
Palisade Bio (Nasdaq:PALI) will participate in the Leerink Partners Therapeutics Forum on July 14-15, 2026, in Boston, Massachusetts. CEO JD Finley and President & CMO Dr. Mitchell Jones will attend.
Management plans one-on-one meetings with institutional investors to discuss Palisade Bio's clinical development strategy, recent progress advancing PALI-2108, and upcoming milestones across its inflammatory bowel disease programs.