BioSpace15 小时
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
FierceBiotech19 小时
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow.
The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.
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 ...
Applied Therapeutics stock craters 75% on FDA setback
Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...
Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...
BioPharma Dive13 小时
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s treatment for classic galactosemia.
腾讯网3 天
美股异动 | Applied Therapeutics(APLT.US)开盘重挫76% 创纪录跌幅
智通财经APP获悉，周五，Applied Therapeutics ...
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 ...
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。
Applied Therapeutics开盘重挫76% 创纪录跌幅
周五，Applied Therapeutics (APLT.US)开盘重挫76%，创纪录跌幅，市值已不足3亿美元，股价报2.12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。
Baird下调Applied Therapeutics股票目标价，但认为SORD缺陷治疗获批可能性大
在其他近期新闻中，Applied Therapeutics遭到RBC Capital Markets从"跑赢大市"降级至"行业表现"。这一调整是在公司收到美国食品和药物管理局（FDA）对其用于治疗半乳糖血症的药物govorestat的完整回复函（CRL）之后做出的。尽管遭遇挫折，该公司在SORD缺陷项目上仍被认为具有潜力，预计将在2025年第一季度提交新药申请（NDA）。 此外，Applied ...