IRWD Ironwood Pharma

Ironwood: FDA sets May 24 PDUFA for LINZESS sNDA in pediatric FC

FDA accepted the sNDA and granted priority review for LINZESS in functional constipation (ages 2-5). A PDUFA target action date of May 24, 2026 has been assigned, establishing a near-term regulatory decision point for this pediatric label expansion.

Ironwood finalizes STARS-2 Phase 3 design for apraglutide in SBS-IF

Ironwood aligned with FDA on key design elements of the confirmatory Phase 3 STARS-2 trial for apraglutide in SBS-IF. The 24-week global, randomized, double-blind, placebo-controlled study will measure relative change from baseline in weekly parenteral support volume. Site initiations are expected to begin in Q2 2026.

Ironwood: FDA approves LINZESS for IBS-C in patients 7 years and older

The FDA approved LINZESS (linaclotide) for the treatment of IBS-C in children 7 years and older, making it the first and only prescription drug approved for this indication in the 7-17 age group. This label expansion broadens the drug's clinical utility beyond its prior adult indication. The approval is stated as a completed regulatory outcome in the November 10, 2025 press release.