3 Articles
3 Articles
Ironwood reports updates on apraglutide following FDA interaction - BioTuesdays
Ironwood Pharmaceuticals (NASDAQ:IRWD) announced that a confirmatory Phase 3 trial evaluating apraglutide in short bowel syndrome with intestinal failure (SBS-IF) and dependence on parenteral support, is a requirement to seek regulatory approval, according to the FDA. The company also announced that it has engaged Goldman Sachs to explore strategic alternatives to maximize stockholder value. In a statement Tom McCourt, CEO of Ironwood, said, “We…
Ironwood to look for alternative paths after FDA asks for another Phase 3
Ironwood Pharmaceuticals is now working with Goldman Sachs in its hunt for company alternatives after getting regulatory feedback from the FDA. The Boston drugmaker hoped to get the agency's blessing for apraglutide, its drug for ...
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