Palisade Bio Stock Up 14% FDA Clearance

Palisade Bio Stock Up 14% FDA Clearance

Palisade Bio Inc (NASDAQ:PALI) saw its shares rise approximately 14% on Monday, 29 June 2026, after the U.S. Food and Drug Administration granted clearance of the company’s Investigational New Drug (IND) application for PALI‑2108. The clearance permits Palisade to commence the global Phase 2 ASCENTRA‑UC clinical trial, a multicenter, randomized, double‑blind, placebo‑controlled, dose‑ranging study in patients with moderately to severely active ulcerative colitis.

The ASCENTRA‑UC trial is slated to enroll roughly 204 patients across North America and Europe and will compare two once‑daily oral dose levels of PALI‑2108—15 mg and 30 mg—against a placebo arm. The primary efficacy endpoint is clinical remission at Week 12, assessed by the modified Mayo Score. Key secondary endpoints include clinical response, endoscopic improvement, and histologic‑endoscopic mucosal improvement. Following the 12‑week induction period, patients who meet eligibility criteria will enter a 36‑week maintenance phase, extending the evaluation of response durability through Week 48.

Palisade anticipates enrolling the first patient in the second half of 2026, with primary efficacy data expected in the second half of 2027. Execution of the ASCENTRA‑UC program will be managed by PSI, a contract research organization partnered with Palisade for trial conduct. In addition, Palisade disclosed plans to submit an IND application for a Crohn’s disease trial, designated ASCENTRA‑CD, also targeted for the second half of 2026.