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 are disappointed in this outcome, as we firmly believe apraglutide has the potential to provide tremendous value to patients with SBS-IF who suffer from increased mortality and reduced quality of life, and will now have to wait for the results of a confirmatory Phase 3 trial.”
“We are focused on the best path forward to get apraglutide to market, which we believe still has the potential to be a blockbuster drug. Concurrently, we will be exploring strategic alternatives for the company in an effort to maximize stockholder value. We are grateful to the patients, families, and clinicians who have and continue to support our clinical development programs,” he added.
