Ironwood Pharmaceuticals Stock Plunges, FDA Wants Another Trial For Gastrointestinal Drug
Ironwood Pharmaceuticals, Inc. IRWD on Monday announced that the U.S. Food and Drug Administration (FDA) wants a confirmatory Phase 3 trial to approve apraglutide for short bowel syndrome with intestinal failure.Ironwood has engaged Goldman Sachs Group Inc GS to explore strategic alternatives.Apraglutide is a once-weekly, long-acting synthetic GLP-2 analog with the potential to treat rare gastrointestinal diseases.In preparation for the new drug application (NDA) submission, pharmacokinetic analysis indicat ...