原始来源记录
决策级FDA 批准
Lantheus：FDA批准PYLARIFY TruVu（piflufolastat F18）
FDA已授予PYLARIFY TruVu完全批准，这是公司PSMA PET成像剂的新制剂。计划于2026年第四季度开始分阶段地理商业化上市，与编码、覆盖、支付和PMF准备工作保持一致。该批准提升了生产效率和供应灵活性。
关键事实
- 申报时间
- 2026年5月7日 11:36
- 事件
- FDA 批准
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年3月6日 · 已批准
来源摘录
EX-99.1 2 lnth-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Lantheus Reports First Quarter 2026 Financial Results and Provides Business Update • Strong start to the year with worldwide revenue of $377.3 million in the first quarter 2026 • GAAP fully diluted earnings per share of $1.80, compared to $1.02 in the first quarter of 2025 • Adjusted fully diluted earnings per share of $1.46, compared to $1.53 in the first quarter of 2025 • FDA approves PYLARIFY TruVu TM (piflufolastat F18); phased geographic launch planned to begin in the fourth quarter of 2026 • FDA tentative approval for Lutetium Lu 177 Dotatate (PNT2003); expected to be the first radioequivalent for the treatment of gastroenteropancreatic neuroendocrine tumors • Reaffirmed previously issued corporate guidance for full year