Primary-source record
Decision-gradePDUFA date set
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.
Key facts
- Filed
- May 7, 2026, 11:10 AM
- Event
- PDUFA date set
- Direction
- Neutral
- Company
IRWDIronwood Pharma- Asset
- linaclotide
- Source
- SEC 8-K
- Confidence
- Sourced
- Calendar
- FDA decision (PDUFA) · May 24, 2026 · Outcome not recorded
Source excerpt
EX-99.1 2 tm267094d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 FOR IMMEDIATE RELEASE Ironwood Pharmaceuticals Reports Strong First Quarter 2026 Results with 97% year-over-year LINZESS U.S. Net Sales Growth; Maintains Full-Year 2026 Financial Guidance – LINZESS® (linaclotide) U.S. net sales of $273 million in Q1 2026, primarily driven by improved net price and 5% EUTRx demand growth year-over-year – – Total revenue of $107 million, GAAP net income of $41 million and adjusted EBITDA of $77 million in Q1 2026 – – On track to begin site initiations for Phase 3 confirmatory trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) in the second quarter of 2026 – – sNDA for LINZESS treatment of functional constipation (FC) in patients 2 to 5 years of age accepted and granted priority review by FDA; PDUFA date set for May 24 th – BOSTON, Mass., May 7, 2026 — Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today reported its first quarter 2026 results and recent business performance. “Our first quarter of 2026 delivered strong financial performance, driven by significantly improved net price and mid-single digit prescription growth for LINZESS, positioning us well to achieve our full-year 2026 financial guidance,” said Tom McCourt, chief executive officer of Ironwood. “We expect strong first quarter revenue to result in