Palisade Bio Says FDA Clears IND Application For PALI-2108, Enabling Initiation Of Global Phase 2 ASCENTRA-UC Clinical Trial In Patients Wit

ASCENTRA-UC expected to enroll up to 204 patients with moderately to severely active ulcerative colitis across North America and Europe First patient enrollment anticipated in the second half of 2026; primary efficacy results expected in the second half of 2027 IND clearance marks a major development milestone for PALI-2108 and supports continued advancement of the Company’s inflammatory bowel disease portfolio Denver, CO, June 29, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (NASDAQ: PALI ) ("Palisade" or the "Company"), a clinical-stage biopharmaceutical company developing next-generation oral PDE4 inhibitor prodrugs for inflammatory bowel disease, today announced that the U.S.

Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for PALI-2108, enabling initiation of the global Phase 2 ASCENTRA-UC clinical trial in patients with moderately to severely active ulcerative colitis (UC).

The Company anticipates initiating patient enrollment in the second half of 2026, with primary efficacy results expected in the second half of 2027.