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BioVie | 8-K: Current report

BioVie | 8-K:重大事件

美股SEC公告 ·  03/12 05:04

牛牛AI助理已提取核心訊息

On March 11, 2024, BioVie Inc., a clinical-stage company focusing on neurological and neurodegenerative disorders as well as advanced liver disease, announced significant updates on its drug candidate pipeline and clinical priorities. The announcement followed the completion of a financing round that raised approximately $18.8 million, enabling the company to advance its clinical trials. BioVie revealed plans for a Phase 2b trial of NE3107 as a first-line monotherapy for Parkinson's Disease (PD), with the trial expected to launch in late summer 2024. Additionally, a once-daily formulation of NE3107 is anticipated to be ready by early 2025 for a Phase 3 trial in Alzheimer's Disease (AD). The company also discussed the Phase 3 trial for BIV201 in ascites following FDA feedback, noting that the program's progression is contingent on partnership funding. The press release included forward-looking statements regarding the potential impact of NE3107 on cognition and function among study participants and the anticipated progress of clinical trials for its product candidates.
On March 11, 2024, BioVie Inc., a clinical-stage company focusing on neurological and neurodegenerative disorders as well as advanced liver disease, announced significant updates on its drug candidate pipeline and clinical priorities. The announcement followed the completion of a financing round that raised approximately $18.8 million, enabling the company to advance its clinical trials. BioVie revealed plans for a Phase 2b trial of NE3107 as a first-line monotherapy for Parkinson's Disease (PD), with the trial expected to launch in late summer 2024. Additionally, a once-daily formulation of NE3107 is anticipated to be ready by early 2025 for a Phase 3 trial in Alzheimer's Disease (AD). The company also discussed the Phase 3 trial for BIV201 in ascites following FDA feedback, noting that the program's progression is contingent on partnership funding. The press release included forward-looking statements regarding the potential impact of NE3107 on cognition and function among study participants and the anticipated progress of clinical trials for its product candidates.
2024年3月11日,專注於神經系統和神經退行性疾病以及晚期肝病的臨床階段公司BioVie Inc. 宣佈了其候選藥物管線和臨床優先事項的重大更新。該公告是在一輪融資完成之後發佈的,該輪融資籌集了約1,880萬美元,使該公司能夠推進其臨床試驗。BioVie透露了將作爲帕金森氏病(PD)一線單一療法的 NE3107 進行2b期試驗的計劃,該試驗預計將於2024年夏末啓動。此外,預計每天一次的 NE3107 配方將於 2025 年初準備就緒,用於阿爾茨海默氏病 (AD) 的 3 期試驗。根據美國食品藥品管理局的反饋,該公司還討論了針對腹水 BIV201 的三期試驗,並指出該計劃的進展取決於合作資金。該新聞稿包括有關 NE3107 對研究參與者認知和功能的潛在影響以及其候選產品的臨床試驗預期進展的前瞻性陳述。
2024年3月11日,專注於神經系統和神經退行性疾病以及晚期肝病的臨床階段公司BioVie Inc. 宣佈了其候選藥物管線和臨床優先事項的重大更新。該公告是在一輪融資完成之後發佈的,該輪融資籌集了約1,880萬美元,使該公司能夠推進其臨床試驗。BioVie透露了將作爲帕金森氏病(PD)一線單一療法的 NE3107 進行2b期試驗的計劃,該試驗預計將於2024年夏末啓動。此外,預計每天一次的 NE3107 配方將於 2025 年初準備就緒,用於阿爾茨海默氏病 (AD) 的 3 期試驗。根據美國食品藥品管理局的反饋,該公司還討論了針對腹水 BIV201 的三期試驗,並指出該計劃的進展取決於合作資金。該新聞稿包括有關 NE3107 對研究參與者認知和功能的潛在影響以及其候選產品的臨床試驗預期進展的前瞻性陳述。

譯文內容由第三人軟體翻譯。


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