share_log

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 已提取核心訊息
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度製藥公司宣佈授予肯塔基大學ARAODA(替非諾奎)新藥申請文件的參考權。該參考權使FDA在考慮肯塔基大學研究SJ733相2b期治療間日瘧計劃時能夠評估60度製藥公司關於ARAKODA的數據。該2b期研究由全球衛生創新科技基金贊助,將SJ733與一劑替非諾奎聯合使用,以評估安全性,耐受性和藥代動力學。肯塔基大學與Eisai Co. Ltd.合作,旨在開發適用於所有無併發症P. vivax瘧疾患者的治療方案。60度製藥公司將爲試驗提供替非諾奎和安慰劑。ARAKODA已獲得2018年FDA批准,用於瘧疾預防,並已在多項試驗中評估長達六個月。專業從事傳染病治療的該公司於2018年獲得了FDA的批准,並與全球各種研究機構合作。
2024年8月12日,60度製藥公司宣佈授予肯塔基大學ARAODA(替非諾奎)新藥申請文件的參考權。該參考權使FDA在考慮肯塔基大學研究SJ733相2b期治療間日瘧計劃時能夠評估60度製藥公司關於ARAKODA的數據。該2b期研究由全球衛生創新科技基金贊助,將SJ733與一劑替非諾奎聯合使用,以評估安全性,耐受性和藥代動力學。肯塔基大學與Eisai Co. Ltd.合作,旨在開發適用於所有無併發症P. vivax瘧疾患者的治療方案。60度製藥公司將爲試驗提供替非諾奎和安慰劑。ARAKODA已獲得2018年FDA批准,用於瘧疾預防,並已在多項試驗中評估長達六個月。專業從事傳染病治療的該公司於2018年獲得了FDA的批准,並與全球各種研究機構合作。
声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息