FDA requires confirmatory Phase 3 trial for apraglutide; Ironwood explores strategic alternatives

IRONWOOD PHARMACEUTICALS INC

FDA feedback indicates a confirmatory Phase 3 trial is needed to seek approval of apraglutide for SBS-IF; company will work on design and regulatory path.
Pharmacokinetic analysis found exposure and dose in STARS Phase 3 trial were lower than planned due to dose preparation and administration.
Ironwood has engaged Goldman Sachs & Co. LLC to explore strategic alternatives to maximize stockholder value.
Long-term extension data: 27 apraglutide-dosed patients achieved enteral autonomy (no parenteral support); STARS data remains part of NDA package.

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