Aquestive Therapeutics(AQST)盘前股价升4成 称Anaphylm新药仅包装管理需整改

金吾财讯
Feb 02

金吾财讯 | Aquestive Therapeutics(AQST)盘前股价拉升,暂报4.21美元,升幅42%。消息面上,公司于2026年1月30日收到了美国食品和药物管理局(FDA)发出的完整回应信(CRL),该信函针对其寻求批准用于治疗I型过敏反应(包括过敏性休克)的一款新药申请(NDA),该药品为Anaphylm(dibutepinephrine)舌下膜剂,适用于体重大于30公斤(约66磅)的患者。公司表示,该药品缺陷仅限于包装和管理。公司相信能够迅速解决缺陷,并预计最早在2026年第三季度重新提交。

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