Entera Bio股价飙升,FDA同意EB613以BMD为终点指标

英为财情
Jul 28, 2025

Investing.com -- 在美国食品药品监督管理局(FDA)同意该公司的EB613新药申请(NDA)可以使用骨密度(BMD)作为其第3期研究的主要终点指标,而非骨折发生率后,Entera Bio Ltd (NASDAQ:ENTX)股价在盘前交易中跃升9.1%。 这一监管协议代表了对骨质疏松症药物先前要求的重大转变,此类药物通常要求在安慰剂对照的第3期研究中以骨折减少作为主要终点指标。相反,...

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