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U.S. FDA Accepts Acadia's Filing For Rett Syndrome Candidate Under Priority Review
U.S. FDA Accepts Acadia's Filing For Rett Syndrome Candidate Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted for filing Acadia Pharmaceuticals' (NASDAQ:ACAD) New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome.
The regulatory agency has granted a priority review and assigned a PDUFA action date of March 12, 2023.
The NDA submission is supported by data readout from the Phase 3 Lavender study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
The Lavender study demonstrated a statistically significant improvement over placebo on the co-primary endpoints.
Steve Davis, Acadia's Chief Executive Officer, said, "We're pleased that the FDA has accepted our NDA filing and we will be working closely with them to facilitate completion of the review in a timely manner. If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare and devastating condition for patients and their families. This milestone reinforces Acadia's ongoing commitment to advancing research into high unmet needs in disorders affecting the central nervous system."
The agency has also informed the company that at this time they are not planning to hold an Advisory Committee meeting.
Trofinetide has been granted Fast Track Status, Orphan Drug Designation and Rare Pediatric Disease (RPD) designation by the FDA.
Rett syndrome is a rare genetic neurodevelopmental disorder that occurs primarily in females following a near normal development in the first two years of life.
Price Action : Acadia shares are trading around 1 percent higher at $17.60 on Monday during pre-market session.
The U.S. Food and Drug Administration (FDA) has accepted for filing Acadia Pharmaceuticals' (NASDAQ:ACAD) New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome.
美国食品药品监督管理局(FDA)已接受阿卡迪亚制药(纳斯达克股票代码:ACAD)提交用于治疗雷特综合征的曲非奈肽新药申请(NDA)。
The regulatory agency has granted a priority review and assigned a PDUFA action date of March 12, 2023.
监管机构已批准优先审查,并将PDUFA的行动日期定为2023年3月12日。
The NDA submission is supported by data readout from the Phase 3 Lavender study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women aged 5-20 years with Rett syndrome.
NDA提交的材料得到了Lavender3期研究的数据的支持,该研究评估了trofinetide对比安慰剂在187名患有Rett综合征的5-20岁女孩和年轻女性中的疗效和安全性。
The Lavender study demonstrated a statistically significant improvement over placebo on the co-primary endpoints.
薰衣草研究表明,在共生终点上,与安慰剂相比,有统计学上的显著改善。
Steve Davis, Acadia's Chief Executive Officer, said, "We're pleased that the FDA has accepted our NDA filing and we will be working closely with them to facilitate completion of the review in a timely manner. If approved, trofinetide will be the first drug available for the treatment of Rett syndrome, a rare and devastating condition for patients and their families. This milestone reinforces Acadia's ongoing commitment to advancing research into high unmet needs in disorders affecting the central nervous system."
阿卡迪亚首席执行官史蒂夫·戴维斯表示:“我们很高兴美国食品药品管理局接受了我们的保密协议申请,我们将与他们密切合作,促进审查的及时完成。如果获得批准,trofinetide将成为第一种可用于治疗雷特综合征的药物,雷特综合征对患者及其家属来说是一种罕见的毁灭性疾病。这一里程碑强化了阿卡迪亚对推进对影响中枢神经系统的疾病中高度未满足需求的研究的持续承诺。”
The agency has also informed the company that at this time they are not planning to hold an Advisory Committee meeting.
该机构还告知该公司,他们目前不打算举行咨询委员会会议。
Trofinetide has been granted Fast Track Status, Orphan Drug Designation and Rare Pediatric Disease (RPD) designation by the FDA.
Trofinetide已被FDA授予快速通道资格、孤儿药资格和罕见儿科疾病(RPD)称号。
Rett syndrome is a rare genetic neurodevelopmental disorder that occurs primarily in females following a near normal development in the first two years of life.
雷特综合征是一种罕见的遗传性神经发育障碍,主要发生在出生后的头两年发育接近正常的女性身上。
Price Action : Acadia shares are trading around 1 percent higher at $17.60 on Monday during pre-market session.
价格走势:周一盘前交易时段,阿卡迪亚股价上涨约1%,至17.60美元。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
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