原始来源记录
决策级PDUFA 日期确定
Ironwood：FDA为LINZESS治疗儿童FC的sNDA设定5月24日PDUFA日期
FDA已受理sNDA并授予LINZESS治疗功能性便秘（2-5岁）的优先审评。已确定2026年5月24日的PDUFA目标行动日期，为此次儿科标签扩展确立了近期的监管决策节点。
关键事实
- 申报时间
- 2026年5月7日 11:10
- 事件
- PDUFA 日期确定
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年5月24日 · 已批准
来源摘录
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