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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Tonix Pharmaceuticals | 8-K：Tonix Pharmaceuticals公佈2023年第四季度全年財務業績和運營亮點
SEC announcement ·  04/02 04:43
牛牛AI助理已提取核心訊息
On April 1, 2024, Tonix Pharmaceuticals Holding Corp. reported its financial results for the fourth quarter and full year ended December 31, 2023. The company announced positive outcomes from the Phase 3 RESILIENT study of Tonmya™ for fibromyalgia, positioning it for a New Drug Application (NDA) submission in the second half of 2024. A preNDA meeting with the FDA is scheduled for the second quarter of 2024. Tonix is also preparing for the U.S. launch of Tonmya, including commercial planning and supply chain strategies. The company's CEO, Seth Lederman, highlighted the focus on seeking U.S. marketing approval for Tonmya from the FDA. Tonix is also pursuing partnerships and collaborations to leverage resources and advance its pipeline programs. The company reported net product revenue of...Show More
On April 1, 2024, Tonix Pharmaceuticals Holding Corp. reported its financial results for the fourth quarter and full year ended December 31, 2023. The company announced positive outcomes from the Phase 3 RESILIENT study of Tonmya™ for fibromyalgia, positioning it for a New Drug Application (NDA) submission in the second half of 2024. A preNDA meeting with the FDA is scheduled for the second quarter of 2024. Tonix is also preparing for the U.S. launch of Tonmya, including commercial planning and supply chain strategies. The company's CEO, Seth Lederman, highlighted the focus on seeking U.S. marketing approval for Tonmya from the FDA. Tonix is also pursuing partnerships and collaborations to leverage resources and advance its pipeline programs. The company reported net product revenue of approximately $7.8 million for the full year 2023, with a net loss of $116.7 million, or $6.85 per share. As of December 31, 2023, Tonix had cash and cash equivalents of about $24.9 million. The company completed the acquisition of Zembrace® SymTouch® and Tosymra® from Upsher-Smith Laboratories, LLC, and transitioned to a fully integrated pharmaceutical company. Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.
2024年4月1日，Tonix Pharmicals Holding Corp. 公佈了截至2023年12月31日的第四季度和全年財務業績。該公司宣佈了Tonmya™ 針對纖維肌痛的3期彈性研究取得積極成果，使其有望在2024年下半年提交新藥申請（NDA）。Prenda計劃於2024年第二季度與美國食品藥品管理局舉行會議。Tonix還在爲美國推出Tonmya做準備，包括商業規劃和供應鏈戰略。該公司首席執行官塞思·萊德曼強調，重點是尋求美國食品藥品管理局對Tonmya的美國上市許可。Tonix還尋求夥伴關係和合作，以利用資源並推進其管道計劃。該公司報告稱，2023年全年淨產品收入約爲780萬美元...展開全部
2024年4月1日，Tonix Pharmicals Holding Corp. 公佈了截至2023年12月31日的第四季度和全年財務業績。該公司宣佈了Tonmya™ 針對纖維肌痛的3期彈性研究取得積極成果，使其有望在2024年下半年提交新藥申請（NDA）。Prenda計劃於2024年第二季度與美國食品藥品管理局舉行會議。Tonix還在爲美國推出Tonmya做準備，包括商業規劃和供應鏈戰略。該公司首席執行官塞思·萊德曼強調，重點是尋求美國食品藥品管理局對Tonmya的美國上市許可。Tonix還尋求夥伴關係和合作，以利用資源並推進其管道計劃。該公司報告稱，2023年全年淨產品收入約爲780萬美元，淨虧損1.167億美元，合每股虧損6.85美元。截至2023年12月31日，Tonix的現金及現金等價物約爲2490萬美元。該公司完成了對Upsher-Smith Laboratories, LLC對Zembrace® SymTouch® 和Tosymra® 的收購，並過渡到一家完全整合的製藥公司。Tonix的候選產品是研究中的新藥或生物製劑，尚未獲得任何適應症的批准。

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