Ironwood Says Feedback From FDA Indicates That Confirmatory Phase 3 Trial Is Needed To Seek Approval Of Apraglutide For Patients With SBS With Intestinal Failure

– Feedback from recent FDA interaction indicates that a confirmatory Phase 3 trial evaluating apraglutide in SBS-IF is needed to seek approval –

– Company has engaged Goldman Sachs & Co. LLC to explore strategic alternatives –

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support. While continuing to advance apraglutide, Ironwood has engaged Goldman Sachs & Co. LLC to explore strategic alternatives for the company to maximize value for stockholders.