FDA Clears PALI-2108 for Phase 2 Ulcerative Colitis Trial, Enrollment Starts H2 2026
PALI has more than doubled off its 52-week low of $0.53 on elevated volume (5.9× avg).
Summary
Palisade Bio received FDA clearance for its Investigational New Drug (IND) application for PALI-2108, allowing it to initiate a global Phase 2 study for ulcerative colitis. This follows positive Phase 1 data announced on May 5th. The trial, expected to enroll up to 204 patients, will begin enrollment in the second half of 2026, with primary efficacy results anticipated in the second half of 2027. This IND clearance is a critical de-risking event and a major development milestone for the company's lead program. The company also plans to submit an IND for PALI-2108 in Crohn's disease in the second half of 2026. Palisade Bio recently secured shareholder approval for increased authorized shares and filed a $300 million shelf registration, providing capital raising flexibility for these advancing trials.
At the time of this announcement, PALI was trading at $1.87 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $328.1M. The 52-week trading range was $0.53 to $2.86. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.