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

SEC announcement ·  Apr 2 04:43
Summary by Futu AI
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.

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