Ironwood Pharmaceuticals’ future looks uncertain after it revealed on 14 April that the US Food and Drug Administration indicated that it will need to see a confirmatory Phase III trial on top of data the firm already has produced for its GLP-2 analog apraglutide in short bowel syndrome. The Boston biotech said it will work with the agency to design a new Phase III trial but is also considering its strategic alternatives.
Key Takeaways
- An FDA request for a confirmatory Phase III trial for its lead candidate apraglutide, puts Ironwood is in financial straits, with declining revenue for its...
The regulatory setback comes after Ironwood initiated a rolling submission to the FDA in January for apraglutide in SBS with intestinal failure (SBS-IF), an indication that would put it in...
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