Ironwood Pharmaceuticals, Inc. (NASDAQ: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 (NYSE: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 indicated that the exposure and dose delivered in the STARS Phase 3 trial were lower than planned due to dose preparation and administration.

Based on the strength of the STARS Phase 3 results, Ironwood believed there was a regulatory path forward.

Following a recent dialogue with the FDA, the company said a confirmatory Phase 3 trial is needed to seek approval.

Ironwood plans to work with the FDA on designing a confirmatory Phase 3 trial and the regulatory path forward.

Apraglutide generated strong safety and efficacy data in the STARS Phase 3 trial. Following an analysis of long-term extension trial data, 27 apraglutide-dosed patients dependent on parenteral support achieved enteral autonomy, which is the ultimate goal for these patients. Consistent with FDA discussions, Ironwood plans to continue the long-term extension trial and believes the data from the STARS trial will continue to be an integral part of an NDA submission package.

“We are disappointed in this outcome,” Tom McCourt, CEO of Ironwood.

Apraglutide has the potential to provide “tremendous value to patients with SBS-IF who suffer from increased mortality and reduced quality of life,” McCourt added.

Ironwood initiated the rolling new drug application to the FDA for apraglutide for SBS, with submission completion expected in Q3 2025.

Price Action: IRWD stock is down 30.28% at 66 cents at the last check Monday.

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