Rezolute获得FDA批准RZ358用于肿瘤高胰岛素血症患者低血糖的IND应用，计划进行3期试验。 Rezolute receives FDA clearance for IND application of RZ358 for hypoglycemia in tumor hyperinsulinism patients, planning Phase 3 trials.
美国食品和药物管理局批准Rezolute用于IND应用RZ358治疗瘤高胰岛素患者的低血糖症. Rezolute receives FDA clearance for its IND application for RZ358 to treat hypoglycemia in tumor hyperinsulinism patients. 美国将在2025年上半年开始进行第三期注册研究,同时正在进行全球性第三期先天性高胰岛素症试验,并等待2025年中期的前期数据. A Phase 3 registrational study will commence in the U.S. in H1 2025, with a global Phase 3 trial for congenital hyperinsulinism also underway, awaiting topline data in mid-2025. 雷祖鲁特的股份在这些公告中下降了6%。 Rezolute's shares decline 6% amid these announcements.