原始来源记录
重大申请已受理
Mineralys：FDA接受lorundrostat NDA，设定2026年12月22日PDUFA
FDA已接受lorundrostat用于高血压的NDA，并指定PDUFA目标行动日期为2026年12月22日。该受理将该资产纳入主动监管审查，并设定了明确的决定截止日期。目标日期前的上市前准备活动现已启动。
关键事实
- 申报时间
- 2026年5月6日 20:07
- 事件
- 申请已受理
- 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12月22日 · 积极
来源摘录
EX-99.1 2 mlys2026q18kex991.htm EX-99.1 Document Exhibit 99.1 Mineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update – NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, PA – May 6, 2026 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. “We continue to make strong progress advancing lorundrostat tow