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8-K: Current report

8-K: Current report

8-K:重大事件
美股SEC公告 ·  08/14 16:00
Moomoo AI 已提取核心信息
On August 12, 2024, 60 Degrees Pharmaceuticals, Inc. announced the granting of a right of reference to the University of Kentucky for the company's new drug application for ARAKODA (tafenoquine). This right of reference enables the FDA to review the company's data on ARAKODA as it considers the University of Kentucky's investigational SJ733 Phase IIb program for the treatment of vivax malaria. The Phase IIb study, funded by the Global Health Innovative Technology Fund, will combine SJ733 with a single dose of tafenoquine to assess safety, tolerability, and pharmacokinetics. The University of Kentucky, in collaboration with Eisai Co. Ltd., aims to develop a treatment suitable for all patients with uncomplicated P. vivax malaria. 60 Degrees Pharmaceuticals will supply tafenoquine and placebos for the trial. ARAKODA, approved by the FDA in 2018 for malaria prophylaxis, has been evaluated in several trials for up to six months. The company, which specializes in infectious disease treatments, received FDA approval for ARAKODA in 2018 and collaborates with various research organizations globally.
On August 12, 2024, 60 Degrees Pharmaceuticals, Inc. announced the granting of a right of reference to the University of Kentucky for the company's new drug application for ARAKODA (tafenoquine). This right of reference enables the FDA to review the company's data on ARAKODA as it considers the University of Kentucky's investigational SJ733 Phase IIb program for the treatment of vivax malaria. The Phase IIb study, funded by the Global Health Innovative Technology Fund, will combine SJ733 with a single dose of tafenoquine to assess safety, tolerability, and pharmacokinetics. The University of Kentucky, in collaboration with Eisai Co. Ltd., aims to develop a treatment suitable for all patients with uncomplicated P. vivax malaria. 60 Degrees Pharmaceuticals will supply tafenoquine and placebos for the trial. ARAKODA, approved by the FDA in 2018 for malaria prophylaxis, has been evaluated in several trials for up to six months. The company, which specializes in infectious disease treatments, received FDA approval for ARAKODA in 2018 and collaborates with various research organizations globally.
2024年8月12日,60 Degrees Pharmaceuticals, Inc.宣布授予肯塔基大学对该公司的治疗疟疾新药物申请ARAKODA (tafenoquine) 的参考权。这种参考权使FDA可以在考虑肯塔基大学的研究性SJ733二期b项目治疗间日疟疾时审查该公司的ARAKODA数据。 资助这项IIb研究的是全球卫生创新技术基金,研究将联合SJ733与单剂量tafenoquine以评估安全性、耐受性和药代动力学。肯塔基大学与艾兹艾公司合作,旨在开发适用于所有无并发症P. vivax疟疾患者的治疗方法。60 Degrees Pharmaceuticals将为试验提供tafenoquine和安慰剂。ARAKODA曾在几项长达六个月的试验中接受评估,并于2018年获得FDA批准用于预防疟疾。该公司专门从事传染病治疗,并与全球各种研究机构合作。
2024年8月12日,60 Degrees Pharmaceuticals, Inc.宣布授予肯塔基大学对该公司的治疗疟疾新药物申请ARAKODA (tafenoquine) 的参考权。这种参考权使FDA可以在考虑肯塔基大学的研究性SJ733二期b项目治疗间日疟疾时审查该公司的ARAKODA数据。 资助这项IIb研究的是全球卫生创新技术基金,研究将联合SJ733与单剂量tafenoquine以评估安全性、耐受性和药代动力学。肯塔基大学与艾兹艾公司合作,旨在开发适用于所有无并发症P. vivax疟疾患者的治疗方法。60 Degrees Pharmaceuticals将为试验提供tafenoquine和安慰剂。ARAKODA曾在几项长达六个月的试验中接受评估,并于2018年获得FDA批准用于预防疟疾。该公司专门从事传染病治疗,并与全球各种研究机构合作。
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