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High materiality7/10

FDA Clears IND for PALI-2108; ASCENTRA-CD Advances Crohn’s Phase 2

Sep 22, 2026, 8:46 AM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Regulatory milestones in biotech often trigger positive price moves, particularly for smaller biotechs with binary data risk. IND clearance extends the company’s Crohn’s program, creating potential upside ahead of Phase 2 data readouts.

AI summary

What happened, with direct paths to the underlying reporting

Palisade Bio announced FDA clearance of the IND for PALI-2108, enabling the ASCENTRA-CD Phase 2 trial in moderate-to-severe Crohn’s disease. The multicenter, open-label study targets ~60 patients with first dosing in Q1 2027 and a Week 12 endoscopic readout in Q1 2028. This milestone expands the IBD program beyond ulcerative colitis, potentially increasing long-term value if data are favorable.

  • FDA clears IND for PALI-2108; ASCENTRA-CD Phase 2.
  • Trial enrolls about 60 Crohn’s patients; first dosing targeted Q1 2027.
  • Primary end point is Week 12 endoscopic response; readout in 2028.
  • PALI-2108 is a once-daily PDE4 prodrug activated in ileum/colon.
  • ASCENTRA-CD builds on prior fibrostenotic Crohn’s data.

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