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.

“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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