-
市场
-
产品
-
资讯
-
Moo社区
-
课堂
-
查看更多
-
功能介绍
-
费用费用透明,无最低余额限制
投资选择、功能介绍、费用相关信息由Moomoo Financial Inc.提供
- English
- 中文繁體
- 中文简体
- 深色
- 浅色
Inhibikase Shares Shoot Higher As FDA Announced Clearance To Blood-Cell Cancer Study
Inhibikase Shares Shoot Higher As FDA Announced Clearance To Blood-Cell Cancer Study
The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics' (NASDAQ:IKT) Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro in the treatment of Chronic Myelogenous Leukemia (CML).
IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and enrolling approximately 64 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses.
The company anticipates initiating a bioequivalence study in the second half of 2022.
The study is designed to evaluate the safety profile of IkT-001Pro as well as identify a dose with a similar systemic exposure and pharmacokinetic profile compared to 400 mg imatinib mesylate at 96 hours post administration.
Milton H. Werner, President and Chief Executive Officer, commented: "We are excited to have received the SMP letter from the FDA for IkT-001Pro for CML. This represents the first program to emerge from our novel prodrug platform, which aims to improve the safety and tolerability of approved and novel therapeutics. Based on preclinical studies, we believe that IkT-001Pro has the potential to significantly improve the safety profile of oral imatinib, which may enhance patient adherence and quality of life, potentially leading to better rates of complete cytogenetic response."
Chronic myeloid leukemia (CML) is a slowly progressing cancer that affects the blood and bone marrow.
Price Action : Inhibikase shares are trading around 20 percent higher at $1.05 on Friday during pre-market session.
The U.S. Food and Drug Administration (FDA) has reviewed Inhibikase Therapeutics' (NASDAQ:IKT) Investigational New Drug (IND) application and issued a Study May Procced (SMP) letter for its drug candidate IkT-001Pro in the treatment of Chronic Myelogenous Leukemia (CML).
美国食品药品监督管理局(FDA)审查了Inhibikase Therapeutics(纳斯达克股票代码:IKT)的研究性新药(IND)申请,并就其用于治疗慢性粒细胞白血病(CML)的候选药物ikt-001pro发布了研究May Procced(SMP)信。
IkT-001Pro will be evaluated in a single ascending dose bioequivalence study and enrolling approximately 64 male and female healthy volunteers aged 25 to 55 who will receive IkT-001Pro at one of four doses.
IKT-001pro将在一项单剂量递增生物等效性研究中接受评估,该研究将招收大约64名年龄在25至55岁之间的男性和女性健康志愿者,他们将接受四剂之一的ikt-001pro。
The company anticipates initiating a bioequivalence study in the second half of 2022.
该公司预计将在2022年下半年启动一项生物等效性研究。
The study is designed to evaluate the safety profile of IkT-001Pro as well as identify a dose with a similar systemic exposure and pharmacokinetic profile compared to 400 mg imatinib mesylate at 96 hours post administration.
该研究旨在评估IKT-001pro的安全性,并确定与给药后96小时内400 mg甲磺酸伊马替尼相比,具有相似的全身暴露和药代动力学特征的剂量。
Milton H. Werner, President and Chief Executive Officer, commented: "We are excited to have received the SMP letter from the FDA for IkT-001Pro for CML. This represents the first program to emerge from our novel prodrug platform, which aims to improve the safety and tolerability of approved and novel therapeutics. Based on preclinical studies, we believe that IkT-001Pro has the potential to significantly improve the safety profile of oral imatinib, which may enhance patient adherence and quality of life, potentially leading to better rates of complete cytogenetic response."
总裁兼首席执行官Milton H. Werner评论说:“我们很高兴收到美国食品药品管理局关于CML的ikt-001Pro的SMP信函。这是我们新颖的前药平台中出现的第一个项目,旨在提高已批准和新疗法的安全性和耐受性。根据临床前研究,我们认为IKT-001Pro有可能显著改善口服伊马替尼的安全性,这可能会提高患者的依从性和生活质量,有可能提高完全的细胞遗传学反应率。”
Chronic myeloid leukemia (CML) is a slowly progressing cancer that affects the blood and bone marrow.
慢性粒细胞白血病(CML)是一种进展缓慢的癌症,会影响血液和骨髓。
Price Action : Inhibikase shares are trading around 20 percent higher at $1.05 on Friday during pre-market session.
价格走势:周五盘前交易中,Inhibikase股价上涨约20%,至1.05美元。
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。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
风险及免责提示
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。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用浏览器的分享功能,分享给你的好友吧