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8-K: Current report

8-K: Current report

8-K：重大事件
美股sec公告 ·  06/12 17:27
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On June 11, 2024, 60 Degrees Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug tafenoquine for the treatment of acute babesiosis. This designation provides the company with benefits such as market exclusivity, tax credits, and exemption from certain FDA fees. The company has also partnered with Tufts Medical Center to conduct the first clinical trial evaluating tafenoquine's efficacy and safety in treating human babesiosis. Babesiosis is a disease transmitted by ticks, which can be severe in certain populations. The trial is set to begin recruitment on June 13, 2024, and will involve at least 24 patients. Tafenoquine is already approved for malaria prophylaxis under the name ARAKODA®. The company, which specializes in developing treatments for infectious diseases, is headquartered in Washington D.C. and has a subsidiary in Australia.
On June 11, 2024, 60 Degrees Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug tafenoquine for the treatment of acute babesiosis. This designation provides the company with benefits such as market exclusivity, tax credits, and exemption from certain FDA fees. The company has also partnered with Tufts Medical Center to conduct the first clinical trial evaluating tafenoquine's efficacy and safety in treating human babesiosis. Babesiosis is a disease transmitted by ticks, which can be severe in certain populations. The trial is set to begin recruitment on June 13, 2024, and will involve at least 24 patients. Tafenoquine is already approved for malaria prophylaxis under the name ARAKODA®. The company, which specializes in developing treatments for infectious diseases, is headquartered in Washington D.C. and has a subsidiary in Australia.
2024年6月11日，60度藥業公司宣佈，美國食品和藥物管理局（FDA）已授予其研究藥物Tafenoquine治療急性巴貝氏菌病的孤兒藥物認定。這一認定爲公司提供了市場獨佔性、稅收抵免以及某些FDA費用免除等優惠。該公司還與塔夫茨醫療中心合作，開展第一項對Tafenoquine治療人類巴貝氏菌病效力和安全性評估的臨床試驗。巴貝氏菌病是由蜱蟲傳播的疾病，在一些人群中可能嚴重。該試驗計劃於2024年6月13日開始招募，將涉及至少24名患者。Tafenoquine已經以ARAKODA的名義獲得了治療瘧疾的批准。這家專門致力於研發傳染性疾病治療方法的公司總部位於華盛頓特區，其在澳洲設有子公司。
2024年6月11日，60度藥業公司宣佈，美國食品和藥物管理局（FDA）已授予其研究藥物Tafenoquine治療急性巴貝氏菌病的孤兒藥物認定。這一認定爲公司提供了市場獨佔性、稅收抵免以及某些FDA費用免除等優惠。該公司還與塔夫茨醫療中心合作，開展第一項對Tafenoquine治療人類巴貝氏菌病效力和安全性評估的臨床試驗。巴貝氏菌病是由蜱蟲傳播的疾病，在一些人群中可能嚴重。該試驗計劃於2024年6月13日開始招募，將涉及至少24名患者。Tafenoquine已經以ARAKODA的名義獲得了治療瘧疾的批准。這家專門致力於研發傳染性疾病治療方法的公司總部位於華盛頓特區，其在澳洲設有子公司。
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