Palisade Bio received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for PALI-2108, an ulcerative colitis treatment.
- The approval allows the company to begin its global Phase 2 Ascentra-UC study in patients with moderately to severely active ulcerative colitis.
- The Ascentra-UC trial is expected to enroll up to 204 patients across North America and Europe.
- Palisade Bio also plans to submit an IND application for a Phase 2 Crohn’s disease study, Ascentra-CD, later this year
Shares of Palisade Bio (PALI) surged more than 17% on Monday, clocking their biggest single-day gains in seven months, following a key regulatory clearance of its ulcerative colitis drug.
PALI shares jumped to their highest levels in nearly two months.
FDA Approves IND Application
Palisade Bio received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PALI-2108, allowing the company to begin its global Phase 2 Ascentra-UC study in patients with moderately to severely active ulcerative colitis, a chronic bowel disease.
An IND is a regulatory application that seeks approval to begin testing an investigational drug in human clinical trials. PALI-2108 is a once-daily oral drug designed to target the ileum, a part of the small intestine, and the colon.
PALI-2018 Pipeline
The Ascentra-UC trial is expected to enroll up to 204 patients across North America and Europe. Patient enrollment is scheduled to begin in the second half of 2026, with primary efficacy results anticipated in the second half of 2027.
The randomized, double-blind, placebo-controlled study will evaluate two once-daily doses of PALI-2108 against placebo. Researchers will assess clinical remission after 12 weeks, while eligible participants will continue into a 36-week maintenance phase to measure long-term treatment benefits.
Separately, Palisade Bio also plans to submit an IND application for a Phase 2 Crohn’s disease study, Ascentra-CD, later this year.
Palisade’s Cash Runway Expected To Support Key Phase 2 Data Readouts Through 2028
Palisade’s first-quarter report showed that PALI-2108 clinical trials had significantly increased research and development expenses to $6.4 million from $1.0 million a year earlier.
The company ended the quarter with $132.6 million in cash and cash equivalents, which it expects will fund operations through Phase 2 data readouts for ulcerative colitis in 2027 and Crohn’s disease in early 2028.
Retail Sees 36% Upside Following FDA Approval
Retail sentiment for PALI on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘high’ message volumes.
One user expects the stock to climb beyond $3 due to the FDA approval.
View this Stocktwits post
The stock has declined 12% so far this year.
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