美股异动 | FDA完整回应信中拒绝批准药物 Applied Therapeutics(APLT.US)盘后 ...
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 ...
US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
Zacks.com on MSN7 小时
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
The US Food and Drug Administration (FDA) has declined to approve Applied Therapeutics’ govorestat for classic galactosemia, ...
pharmaphorum11 小时
Applied Tx craters as FDA rejects lead product candidate
The sell-off started last night and continued in after-hours trading after the New York-based biopharma company revealed that ...
FDA拒绝批准Applied Therapeutics公司的半乳糖血症药物
纽约 - 生物制药公司Applied Therapeutics Inc. (NASDAQ:APLT)收到了美国食品和药物管理局 (FDA)关于其新药申请 (NDA)的完整回复函 (CRL)。该公司的govorestat治疗药物旨在治疗经典半乳糖血症,这是一种罕见的代谢疾病,但由于临床应用缺陷,该药物未能以其当前形式获得批准。
The Pharma Letter6 小时
Applied Thera tanks, as FDA slaps CRL on govorestat NDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...
第一黄金网20 小时
FDA完整回应信中拒绝批准药物 Applied Therapeutics(APLT.US)盘后暴跌78%
，周三，Applied Therapeutics(APLT.US)盘后暴跌78%，报1.89美元。消息面上，美国FDA已 ，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， ...
Applied Therapeutics: FDA Issues CRL For New Drug Application For Govorestat - Quick Facts
Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug ...
Govorestat is a central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) being developed for the treatment of multiple rare diseases including Classic Galactosemia, Sorbitol ...
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Applied Therapeutics plunges 83% following Complete Response Letter
The FDA has declined to approve Applied Therapeutics' govorestat, its candidate for the rare metabolic disorder classic ...