FDA Clears PALI-2108 for Crohn's Disease, Expanding Phase 2 Program
PALI has more than doubled off its 52-week low of $0.58.
Summary
Palisade Bio received FDA clearance for its IND for PALI-2108 in Crohn's disease, enabling the Phase 2 ASCENTRA-CD trial in ~60 patients with moderate to severe disease. This expands the drug's development beyond ulcerative colitis and fibrostenotic Crohn's, with first patient dosing targeted for Q1 2027 and primary efficacy readout (Week 12 endoscopic response) in Q1 2028. The company cites prior clinical experience showing targeted tissue exposure, PDE4 target engagement, and encouraging endoscopic activity. This is a significant regulatory milestone for a clinical-stage biotech with a market cap under $300M, as it broadens the addressable patient population and de-risks the program. The news follows the initial IND clearance in June and Q2 financials outlining the Phase 2 path. Key upcoming catalysts are first patient dosing in Q1 2027 and the primary efficacy readout in Q1 2028.
At the time of this announcement, PALI was trading at $1.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $294.5M. The 52-week trading range was $0.58 to $2.86. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.