Tonix Pharmaceuticals Announces Results From Clinical Pharmacokinetic Bridging Study Of Tonmya To Support Development And Partnering in Japan and China
Portfolio Pulse from Benzinga Newsdesk
Tonix Pharmaceuticals plans to expand the development and partnering of Tonmya in Japan and China for the management of fibromyalgia. The company will file a CTN in Japan and an IND in China, leveraging U.S. Phase 3 data without dosage adjustment. Tonmya's market exclusivity in Asia is supported by issued patents, and a U.S. FDA NDA submission is planned for the second half of 2024.
February 27, 2024 | 1:07 pm
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Tonix Pharmaceuticals is advancing the development and partnering of Tonmya in Japan and China, supported by patents in Asia, with plans for a U.S. FDA NDA submission in 2024.
The announcement of Tonix Pharmaceuticals' plans to file for regulatory approval in Japan and China for Tonmya, along with the strategic move to leverage existing U.S. Phase 3 data, indicates a significant step towards international expansion and market exclusivity in Asia. This development, coupled with the planned U.S. FDA NDA submission, is likely to be viewed positively by investors, potentially leading to an increase in TNXP's stock price in the short term.
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