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8-K: Current report

8-K: Current report

8-K：重大事件
美股SEC公告 ·  09/16 08:36

Moomoo AI 已提取核心訊息

On September 16, 2024, Clene Inc., a late-stage biopharmaceutical company, announced an upcoming in-person meeting with the U.S. Food and Drug Administration (FDA) to discuss the CNM-Au8 biomarker and related clinical and survival data. The meeting, scheduled before the end of November 2024, will involve senior FDA officials and key opinion leaders in the field of amyotrophic lateral sclerosis (ALS). This follows a recent communication from the FDA's Division of Neurology 1 (DN1) indicating that Clene's briefing package was initially not supportive of an accelerated approval pathway for CNM-Au8. However, subsequent discussions led to the FDA agreeing to re-evaluate the submission. Clene aims to present expert views on ALS biomarkers and related clinical endpoints during the meeting. The company has gathered over 700 patient-years of safety data for CNM-Au8, with no significant safety concerns or serious adverse events related to the treatment reported. Clene focuses on developing treatments for neurodegenerative diseases by improving mitochondrial health and protecting neuronal function.
On September 16, 2024, Clene Inc., a late-stage biopharmaceutical company, announced an upcoming in-person meeting with the U.S. Food and Drug Administration (FDA) to discuss the CNM-Au8 biomarker and related clinical and survival data. The meeting, scheduled before the end of November 2024, will involve senior FDA officials and key opinion leaders in the field of amyotrophic lateral sclerosis (ALS). This follows a recent communication from the FDA's Division of Neurology 1 (DN1) indicating that Clene's briefing package was initially not supportive of an accelerated approval pathway for CNM-Au8. However, subsequent discussions led to the FDA agreeing to re-evaluate the submission. Clene aims to present expert views on ALS biomarkers and related clinical endpoints during the meeting. The company has gathered over 700 patient-years of safety data for CNM-Au8, with no significant safety concerns or serious adverse events related to the treatment reported. Clene focuses on developing treatments for neurodegenerative diseases by improving mitochondrial health and protecting neuronal function.
2024年9月16日，Clene Inc.，一家處於後期的生物製藥公司，宣佈即將與美國食品和藥物管理局（FDA）舉行面對面會議，討論CNm-Au8生物標誌物及相關臨床和生存數據。此次會議計劃在2024年11月底之前舉行，將邀請FDA的高級官員以及肌萎縮側索硬化（ALS）領域的重要意見領袖參與。此前，FDA神經病學1部（DN1）發來消息，表示Clene的簡報包裝最初並未支持CNm-Au8獲得加速批准路徑。然而，隨後的討論導致FDA同意重新評估提交內容。Clene旨在在會議期間提出有關ALS生物標誌物和相關臨床終點的專家意見。該公司已經收集了超過700病人年的CNm-Au8安全數據，未出現與治療相關的重大安全問題或嚴重不良事件。Clene專注於通過改善線粒體健康和保護神經元功能來開發神經退行性疾病的治療方案。
2024年9月16日，Clene Inc.，一家處於後期的生物製藥公司，宣佈即將與美國食品和藥物管理局（FDA）舉行面對面會議，討論CNm-Au8生物標誌物及相關臨床和生存數據。此次會議計劃在2024年11月底之前舉行，將邀請FDA的高級官員以及肌萎縮側索硬化（ALS）領域的重要意見領袖參與。此前，FDA神經病學1部（DN1）發來消息，表示Clene的簡報包裝最初並未支持CNm-Au8獲得加速批准路徑。然而，隨後的討論導致FDA同意重新評估提交內容。Clene旨在在會議期間提出有關ALS生物標誌物和相關臨床終點的專家意見。該公司已經收集了超過700病人年的CNm-Au8安全數據，未出現與治療相關的重大安全問題或嚴重不良事件。Clene專注於通過改善線粒體健康和保護神經元功能來開發神經退行性疾病的治療方案。
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