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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia

SEC announcement ·  Mar 6 21:08
Summary by Futu AI
On March 6, 2024, Tonix Pharmaceuticals Holding Corp. announced a partnership with EVERSANA Life Science Services, LLC to support the launch and commercial planning of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonix plans to submit a New Drug Application for Tonmya to the FDA in the second half of 2024, following statistically significant results from two Phase 3 trials. The company has also scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024. Tonmya, also known as TNX-102 SL, is a non-opioid, centrally acting analgesic that has shown significant pain reduction and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms in clinical trials.
On March 6, 2024, Tonix Pharmaceuticals Holding Corp. announced a partnership with EVERSANA Life Science Services, LLC to support the launch and commercial planning of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonix plans to submit a New Drug Application for Tonmya to the FDA in the second half of 2024, following statistically significant results from two Phase 3 trials. The company has also scheduled a Type B pre-NDA meeting with the FDA for the second quarter of 2024. Tonmya, also known as TNX-102 SL, is a non-opioid, centrally acting analgesic that has shown significant pain reduction and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms in clinical trials.
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