智通财经APP获悉,周三,Applied Therapeutics(APLT.US)盘后暴跌78%,报1.89美元。消息面上,美国FDA已拒绝批准该公司用于治疗罕见代谢疾病经典半乳糖血症的govorestat。在一封完整的回应信中,FDA表示,由于申请中存在缺陷,它无法批准该药物。
该公司表示,正在审查FDA的意见,并将要求与该机构举行会议,讨论可能重新提交的必要条件。
Govorestat目前正在针对山梨糖醇脱氢酶(SORD)缺乏症进行研究,这是一种罕见且逐渐恶化的神经肌肉疾病。Applied预计将在2025年第一季度初提交该药物用于治疗SORD缺乏症的新药申请。
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