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Clene | 8-K: Current report

Clene | 8-K: Current report

Clene | 8-K:重大事件
美股SEC公告 ·  03/13 08:03

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On March 13, 2024, Clene Inc., a clinical-stage biopharmaceutical company, announced its full-year financial results for the period ending December 31, 2023. The announcement highlighted the company's progress in its clinical programs for neurodegenerative diseases, including ALS and MS, and its discussions with the FDA regarding an accelerated approval pathway for its drug CNM-Au8. Clene reported a net loss of $49.5 million for the year, a decrease in research and development expenses, and a cash position of $35.0 million, which is expected to fund operations into Q4 2024. The company also shared significant clinical data from trials of CNM-Au8, demonstrating benefits in ALS and MS treatments. Clene met with the FDA to discuss regulatory pathways and is preparing additional data to support an accelerated approval filing. The company also highlighted the receipt of a $45.1 million NIH grant and the publication of peer-reviewed articles supporting CNM-Au8's mechanism of action.
On March 13, 2024, Clene Inc., a clinical-stage biopharmaceutical company, announced its full-year financial results for the period ending December 31, 2023. The announcement highlighted the company's progress in its clinical programs for neurodegenerative diseases, including ALS and MS, and its discussions with the FDA regarding an accelerated approval pathway for its drug CNM-Au8. Clene reported a net loss of $49.5 million for the year, a decrease in research and development expenses, and a cash position of $35.0 million, which is expected to fund operations into Q4 2024. The company also shared significant clinical data from trials of CNM-Au8, demonstrating benefits in ALS and MS treatments. Clene met with the FDA to discuss regulatory pathways and is preparing additional data to support an accelerated approval filing. The company also highlighted the receipt of a $45.1 million NIH grant and the publication of peer-reviewed articles supporting CNM-Au8's mechanism of action.
2024年3月13日,臨床階段的生物製藥公司Clene Inc. 公佈了截至2023年12月31日的全年財務業績。該公告強調了該公司在神經退行性疾病(包括肌萎縮性側索硬化症和多發性硬化症)臨床項目方面的進展,以及該公司與美國食品藥品管理局就加速其藥物CNM-Au8的批准途徑進行的討論。Clene報告稱,該年度淨虧損4,950萬美元,研發費用減少,現金狀況爲3500萬美元,預計將爲2024年第四季度的運營提供資金。該公司還分享了來自CNM-au8試驗的重要臨床數據,這些數據顯示了ALS和MS治療的好處。克萊恩與美國食品藥品管理局會面,討論監管途徑,並正在準備更多數據以支持加快批准申請。該公司還強調收到了美國國立衛生研究院的4510萬美元撥款,並發表了支持CNM-au8行動機制的同行評審文章。
2024年3月13日,臨床階段的生物製藥公司Clene Inc. 公佈了截至2023年12月31日的全年財務業績。該公告強調了該公司在神經退行性疾病(包括肌萎縮性側索硬化症和多發性硬化症)臨床項目方面的進展,以及該公司與美國食品藥品管理局就加速其藥物CNM-Au8的批准途徑進行的討論。Clene報告稱,該年度淨虧損4,950萬美元,研發費用減少,現金狀況爲3500萬美元,預計將爲2024年第四季度的運營提供資金。該公司還分享了來自CNM-au8試驗的重要臨床數據,這些數據顯示了ALS和MS治療的好處。克萊恩與美國食品藥品管理局會面,討論監管途徑,並正在準備更多數據以支持加快批准申請。該公司還強調收到了美國國立衛生研究院的4510萬美元撥款,並發表了支持CNM-au8行動機制的同行評審文章。
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