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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

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

Tonix Pharmaceuticals | 8-K：Tonix Pharmaceuticals宣佈選擇兩家合同製造組織來推出和商業生產用於管理纖維肌痛的Tonmya™
SEC announcement ·  03/20 21:52
牛牛AI助理已提取核心訊息
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.
2024年3月20日，Tonix Pharmicals Holding Corp. 宣佈選擇包括Almac Pharma Services在內的兩家合同製造組織，爲即將推出的美國纖維肌痛管理候選產品Tonmya™（也稱爲 TNX102 SL）提供雙重供應來源，是一種非阿片類鎮痛藥，在兩項3期研究中均顯示出積極結果。™該公司計劃在2024年下半年向美國食品藥品管理局提交新藥申請。Tonix首席執行官塞思·萊德曼對雙重採購戰略以及與首席營銷官合作提供Tonmya™ 商業供應表示了信心。該公告還強調了RESILIENT研究的成功完成，該研究達到了其主要終點，並顯示與纖維肌痛症狀相關的次要終點有了顯著改善。Tonix Pharmaceuticals專注於開發中樞神經系統疾病的療法，其產品組合包括針對各種疾病的其他候選藥物。
2024年3月20日，Tonix Pharmicals Holding Corp. 宣佈選擇包括Almac Pharma Services在內的兩家合同製造組織，爲即將推出的美國纖維肌痛管理候選產品Tonmya™（也稱爲 TNX102 SL）提供雙重供應來源，是一種非阿片類鎮痛藥，在兩項3期研究中均顯示出積極結果。™該公司計劃在2024年下半年向美國食品藥品管理局提交新藥申請。Tonix首席執行官塞思·萊德曼對雙重採購戰略以及與首席營銷官合作提供Tonmya™ 商業供應表示了信心。該公告還強調了RESILIENT研究的成功完成，該研究達到了其主要終點，並顯示與纖維肌痛症狀相關的次要終點有了顯著改善。Tonix Pharmaceuticals專注於開發中樞神經系統疾病的療法，其產品組合包括針對各種疾病的其他候選藥物。
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