Apraglutide

Ironwood Pharmaceuticals' stock plummeted by 37% after the FDA required a confirmatory Phase 3 trial for apraglutide, a treatment for short bowel syndrome with intestinal failure.

Ironwood Pharmaceuticals has announced that a confirmatory Phase 3 trial will be required for apraglutide in short bowel syndrome with intestinal failure, following its $1 billion acquisition of VectivBio.

The FDA approved mirikizumab (Omvoh) for Crohn's disease, marking its second approval in IBD after ulcerative colitis, based on positive Phase 3 trial results.