矿物治疗公司报告了洛伦多斯塔特的晚期结果,FDA批准了该药物的应用,预计将在2026年12月作出决定. Mineralys Therapeutics reported positive late-stage results for lorundrostat, with FDA acceptance of its application and a decision expected by December 2026.

矿物治疗公司报告了强的2025年第四季度业绩,FDA接受了lorundrostat的NDA并设定了2026年12月22日为PDUFA的目标行动日期. Mineralys Therapeutics reported strong fourth-quarter 2025 results, with the FDA accepting lorundrostat’s NDA and setting a PDUFA target action date of December 22, 2026. 关键试验显示,该药物降低了6. 2 mmHg的静脉压,并具有良好的安全性,尽管该药在睡眠呼吸暂停试验中未达到其主要终点. Pivotal trials showed a 6.2 mmHg systolic blood pressure reduction and favorable safety, though the drug didn’t meet its primary endpoint in a sleep apnea trial. 到年底,现金和投资增至6.566亿美元,到2028年一直支持业务。 Cash and investments rose to $656.6 million by year-end, supporting operations through 2028. 净损失减少到1.547亿美元,该公司计划以使用三线高血压和四线高血压为目标进行商业发射,知识产权保护至少延长到2035年。 Net loss narrowed to $154.7 million, and the company plans commercial launch targeting third- and fourth-line hypertension use, with intellectual property protection extending to at least 2035.