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Cingulate | 8-K: Current report

Cingulate | 8-K:重大事件

美股sec公告 ·  2023/12/28 13:00
牛牛AI助理已提取核心訊息
On December 26, 2023, Cingulate Inc., a pharmaceutical company, received notification from Nasdaq that it no longer meets the independent director and committee requirements for continued listing, following the resignation of three board members earlier in the month. This issue adds to the previously identified non-compliance with the minimum stockholders' equity rule. Cingulate has requested a hearing with the Nasdaq Hearings Panel, scheduled for February 2024, to present a plan to regain compliance. The company's delisting is stayed pending the hearing outcome. In other updates, Cingulate has received FDA guidance for its lead ADHD treatment candidate, CTx-1301, and plans to submit a New Drug Application in the first half of 2025. The company has halted enrollment in two Phase 3 studies for CTx...Show More
On December 26, 2023, Cingulate Inc., a pharmaceutical company, received notification from Nasdaq that it no longer meets the independent director and committee requirements for continued listing, following the resignation of three board members earlier in the month. This issue adds to the previously identified non-compliance with the minimum stockholders' equity rule. Cingulate has requested a hearing with the Nasdaq Hearings Panel, scheduled for February 2024, to present a plan to regain compliance. The company's delisting is stayed pending the hearing outcome. In other updates, Cingulate has received FDA guidance for its lead ADHD treatment candidate, CTx-1301, and plans to submit a New Drug Application in the first half of 2025. The company has halted enrollment in two Phase 3 studies for CTx-1301 and requires approximately $17-21 million to proceed with the NDA filing. Cingulate also plans to initiate clinical plans for CTx-1302 and is in licensing discussions for CTx-2103. The company acknowledges the need to raise approximately $15 million by March 31, 2024, to comply with Nasdaq's stockholders' equity rule and has regained compliance with the minimum bid price requirement after a reverse stock split.
2023年12月26日,製藥公司Cingulate Inc. 收到納斯達克的通知,在三名董事會成員於本月早些時候辭職後,該公司不再符合獨立董事和委員會關於繼續上市的要求。這個問題加劇了先前發現的不遵守最低股東權益規則的情況。Cingulate已要求定於2024年2月與納斯達克聽證會小組舉行聽證會,以提出恢復合規的計劃。在聽證會結果公佈之前,該公司的退市暫緩執行。在其他更新中,Cingulate已收到美國食品藥品管理局對其主要注意力缺陷多動障礙候選藥物CTx-1301的指導,並計劃在2025年上半年提交新藥申請。該公司已停止註冊CTX-1301的兩項3期研究,並需要大約1700萬至2100萬美元才能繼續提交保密協議。Cingulate還計劃啓動CTX-1302的臨床計劃,並正在討論CTX-2103的許可問題。該公司承認,需要在2024年3月31日之前籌集約1500萬美元,以遵守納斯達克的股東權益規則,並且在股票反向拆分後已恢復遵守最低出價要求。
2023年12月26日,製藥公司Cingulate Inc. 收到納斯達克的通知,在三名董事會成員於本月早些時候辭職後,該公司不再符合獨立董事和委員會關於繼續上市的要求。這個問題加劇了先前發現的不遵守最低股東權益規則的情況。Cingulate已要求定於2024年2月與納斯達克聽證會小組舉行聽證會,以提出恢復合規的計劃。在聽證會結果公佈之前,該公司的退市暫緩執行。在其他更新中,Cingulate已收到美國食品藥品管理局對其主要注意力缺陷多動障礙候選藥物CTx-1301的指導,並計劃在2025年上半年提交新藥申請。該公司已停止註冊CTX-1301的兩項3期研究,並需要大約1700萬至2100萬美元才能繼續提交保密協議。Cingulate還計劃啓動CTX-1302的臨床計劃,並正在討論CTX-2103的許可問題。該公司承認,需要在2024年3月31日之前籌集約1500萬美元,以遵守納斯達克的股東權益規則,並且在股票反向拆分後已恢復遵守最低出價要求。

譯文內容由第三人軟體翻譯。


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