Ironwood Pharmaceuticals Plunges 33.4% on FDA Trial Demand

On April 14, 2025, Ironwood Pharmaceuticals experienced a significant drop of 33.4% in pre-market trading.

Ironwood Pharmaceuticals has announced that it will need to conduct a new Phase 3 trial for its drug apraglutide, following feedback from the FDA. The regulatory body has requested additional confirmatory evidence despite positive efficacy data from previous trials. This decision comes after a recent interaction with the FDA, which indicated that a confirmatory Phase 3 trial is necessary to seek approval for apraglutide in patients with short bowel syndrome with intestinal failure (SBS-IF).

In response to this regulatory hurdle, Ironwood Pharmaceuticals has initiated a strategic review with Goldman Sachs to explore various alternatives that could enhance shareholder value. The company remains committed to advancing apraglutide and plans to work closely with the FDA to design the new trial and move forward with regulatory submissions.

The STARS Phase 3 trial, which was the largest of its kind for SBS-IF, showed promising results with apraglutide significantly reducing the volume of parenteral support required. However, the FDA's demand for additional confirmatory evidence has led to the need for a new Phase 3 trial. Ironwood Pharmaceuticals is dedicated to improving treatment options for patients with SBS-IF and will continue to build on the data collected to strengthen their case for apraglutide's approval.