Definium因抑郁症药物获FDA“突破性疗法”认定而股价上涨

路透中文
Sep 08
BUZZ-Definium因抑郁症药物获FDA“突破性疗法”认定而股价上涨

9月8日 - ** Definium TherapeuticsDFTX.O)股价上涨2.2%,至38.92美元

** 该公司表示,其基于LSD的实验性药丸DT120 (link) 获得美国食品药品监督管理局(FDA)授予的突破性疗法认定,用于治疗重度抑郁症(MDD)

** “突破性疗法”认定旨在加速针对严重疾病或存在未满足医疗需求的药物研发和审查进程

** 此前,晚期临床试验数据显示,与安慰剂相比,DT120 显著减轻了 (link) 抑郁症状,FDA 据此授予了该资格

** 斯蒂费尔(Stifel)分析师表示,该认定“再次证明DFTX的试验设计符合FDA的预期”

** DT120目前已同时获得FDA针对MDD和广泛性焦虑障碍的“突破性疗法”认定

** 截至上一交易日收盘,该股年内涨幅已超过一倍

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