Ironwood Pharmaceuticals stock tumbles after FDA requires additional trial

Investing.com -- Shares of Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) plunged 33.5% following the company’s announcement that the U.S. Food and Drug Administration (FDA) requires a confirmatory Phase 3 trial for apraglutide, potentially delaying the drug’s approval for patients with short bowel syndrome (SBS) with intestinal failure (IF) who depend on parenteral support.

The biotechnology firm, which focuses on developing therapies for gastrointestinal and rare diseases, had engaged in discussions with the FDA and initially believed its STARS Phase 3 trial results would pave the way for regulatory approval. However, a recent pharmacokinetic analysis showed that the exposure and dose delivered in the trial were lower than planned due to issues with dose preparation and administration, leading to the FDA’s decision.

Despite the setback, Ironwood reported strong safety and efficacy data from the STARS Phase 3 trial, which is the largest trial for SBS-IF conducted to date. The company also noted that 27 patients treated with apraglutide in a long-term extension trial achieved enteral autonomy, a significant milestone for those dependent on parenteral support.

Ironwood’s CEO, Tom McCourt, expressed disappointment in the FDA’s requirement but remains optimistic about apraglutide’s potential, stating, "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." In parallel with the trial preparations, Ironwood has tasked Goldman Sachs & Co (NYSE:GS). LLC with exploring strategic alternatives to maximize stockholder value.

The news has significantly impacted Ironwood’s stock, as investors react to the prospects of a delayed market entry for apraglutide and the additional costs associated with conducting another Phase 3 trial. The company’s future steps, including the design of the new trial and ongoing strategic evaluations, will be closely watched by stakeholders and the medical community eager for advancements in the treatment of SBS-IF.

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