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Decision-gradeNaitakda ang petsa ng PDUFA

Ironwood: FDA nagtakda ng Mayo 24 PDUFA para sa LINZESS sNDA sa pediatric FC

Tinanggap ng FDA ang sNDA at binigyan ng priority review ang LINZESS para sa functional constipation (edad 2-5). Isang PDUFA target action date na Mayo 24, 2026 ang itinalaga, na nagtatatag ng malapit na regulatory decision point para sa pediatric label expansion na ito.

Mahahalagang fact

Na-file
May 7, 2026, 11:10 AM
Kaganapan
Naitakda ang petsa ng PDUFA
Direksyon
Neutral
Kumpanya
IRWDIronwood Pharma
Asset
linaclotide
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · May 24, 2026 · Inaprubahan

Sipi mula sa source

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 grante

SEC 8-K

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