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8-K: Current report

8-K: Current report

8-K:重大事件
美股sec公告 ·  07/09 15:41
Moomoo AI 已提取核心信息
On July 9, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a clinical trial at Tufts Medical Center for the treatment of Babesiosis using tafenoquine. This trial is significant as it is the first of its kind and aims to confirm the 80% cure rate observed in a previous Yale School of Public Health study. The earlier study, published in Clinical Infectious Diseases, showed promising results in a small group of immunosuppressed patients. While tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA, it is not yet approved for the treatment or prevention of Babesiosis, a tick-borne illness that can be life-threatening, especially in the elderly and immunocompromised. The company's press release, which is...Show More
On July 9, 2024, 60 Degrees Pharmaceuticals, Inc. announced the enrollment of the first patient in a clinical trial at Tufts Medical Center for the treatment of Babesiosis using tafenoquine. This trial is significant as it is the first of its kind and aims to confirm the 80% cure rate observed in a previous Yale School of Public Health study. The earlier study, published in Clinical Infectious Diseases, showed promising results in a small group of immunosuppressed patients. While tafenoquine is currently approved for malaria prophylaxis under the name ARAKODA, it is not yet approved for the treatment or prevention of Babesiosis, a tick-borne illness that can be life-threatening, especially in the elderly and immunocompromised. The company's press release, which is part of the SEC filing, outlines the ongoing efforts to repurpose tafenoquine for Babesiosis treatment, with plans to file a New Drug Application with the FDA in the second quarter of 2026. The company is also conducting additional studies to address the unmet medical needs of different Babesiosis patient populations. 60 Degrees Pharmaceuticals, which specializes in infectious disease treatments, has already achieved FDA approval for ARAKODA for malaria prevention and is actively engaged in research collaborations.
2024年7月9日,60度药品公司宣布在塔夫茨医学中心为Babesiosis的治疗使用tafenoquine进行临床试验的第一个患者报到。该试验意义重大,因为它是首个旨在确认之前耶鲁公共卫生学院研究所观察到的80%治愈率的试验。早期研究发表在《临床传染病学》杂志上,显示在少数免疫抑制患者中的结果令人鼓舞。尽管tafenoquine目前在名为ARAKODA的疟疾预防药品下获批准,但它尚未获批准用于Babesiosis的治疗或预防,这是一种可以危及生命的蜱传疾病,尤其是对老年和免疫功能受损的人群。该公司的新闻稿是SEC备案的一部分,概述了继续利用tafenoquine进行Babesiosis治疗的努力,并计划在2026年第二季度向FDA提交新药申请。该公司还正在进行其他研究,以解决不同Babesiosis患者人群的未满足的医疗需求。专门从事传染病治疗的60度药品公司已经获得了ARAKODA的疟疾预防药品的FDA批准,并积极参与研究合作。
2024年7月9日,60度药品公司宣布在塔夫茨医学中心为Babesiosis的治疗使用tafenoquine进行临床试验的第一个患者报到。该试验意义重大,因为它是首个旨在确认之前耶鲁公共卫生学院研究所观察到的80%治愈率的试验。早期研究发表在《临床传染病学》杂志上,显示在少数免疫抑制患者中的结果令人鼓舞。尽管tafenoquine目前在名为ARAKODA的疟疾预防药品下获批准,但它尚未获批准用于Babesiosis的治疗或预防,这是一种可以危及生命的蜱传疾病,尤其是对老年和免疫功能受损的人群。该公司的新闻稿是SEC备案的一部分,概述了继续利用tafenoquine进行Babesiosis治疗的努力,并计划在2026年第二季度向FDA提交新药申请。该公司还正在进行其他研究,以解决不同Babesiosis患者人群的未满足的医疗需求。专门从事传染病治疗的60度药品公司已经获得了ARAKODA的疟疾预防药品的FDA批准,并积极参与研究合作。
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