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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

SEC announcement ·  Mar 20 21:52
Summary by Futu AI
On March 20, 2024, Tonix Pharmaceuticals Holding Corp. announced the selection of two contract manufacturing organizations, including Almac Pharma Services, to provide dual supply sources for the upcoming launch and commercialization of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonmya™, also known as TNX102 SL, is a non-opioid analgesic that has shown positive results in two Phase 3 studies. The company plans to submit a New Drug Application to the FDA in the second half of 2024. Tonix's CEO, Seth Lederman, expressed confidence in the dual sourcing strategy and the collaboration with the CMOs for the commercial supply of Tonmya™. The announcement also highlighted the successful completion of the RESILIENT study, which met its primary endpoint and showed significant improvements in secondary endpoints related to fibromyalgia symptoms. Tonix Pharmaceuticals is focused on developing therapeutics for central nervous system disorders and has a portfolio that includes other candidates for various conditions.
On March 20, 2024, Tonix Pharmaceuticals Holding Corp. announced the selection of two contract manufacturing organizations, including Almac Pharma Services, to provide dual supply sources for the upcoming launch and commercialization of Tonmya™, a product candidate for the management of fibromyalgia in the U.S. Tonmya™, also known as TNX102 SL, is a non-opioid analgesic that has shown positive results in two Phase 3 studies. The company plans to submit a New Drug Application to the FDA in the second half of 2024. Tonix's CEO, Seth Lederman, expressed confidence in the dual sourcing strategy and the collaboration with the CMOs for the commercial supply of Tonmya™. The announcement also highlighted the successful completion of the RESILIENT study, which met its primary endpoint and showed significant improvements in secondary endpoints related to fibromyalgia symptoms. Tonix Pharmaceuticals is focused on developing therapeutics for central nervous system disorders and has a portfolio that includes other candidates for various conditions.
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