一次情報の記録
決定級PDUFA 日設定
アイアンウッド:小児機能性便秘のLINZESS sNDAのPDUFAを5月24日に設定
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.
主要事実
- 提出
- 2026年5月7日 11:10
- イベント
- PDUFA 日設定
- 方向
- 中立
- アセット
- linaclotide
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- カレンダー
- FDA 審査決定 (PDUFA) · 2026年5月24日 · 承認
出典の抜粋
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