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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

Tonix Pharmaceuticals | 8-K:Tonix Pharmicals选择EVERSANA®来支持用于纤维肌痛管理的Tonmya™的上市战略和商业化规划

SEC announcement ·  03/06 08:08
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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.
2024年3月6日,Tonix Pharmicals Holding Corp. 宣布与EVERSANA Life Science Services, LLC建立合作伙伴关系,以支持美国纤维肌痛管理候选产品Tonmya™ 的推出和商业规划。Tonix计划在2024年下半年向美国食品药品管理局提交Tonmya的新药申请,此前两项3期试验取得了具有统计意义的结果。该公司还计划在2024年第二季度与美国食品药品管理局举行B型保密协议前会议。Tonmya,也被称为 TNX-102 SL,是一种非阿片类中枢作用的镇痛药,在临床试验中显示出明显的疼痛减轻和睡眠质量、疲劳和整体纤维肌痛症状的改善。
2024年3月6日,Tonix Pharmicals Holding Corp. 宣布与EVERSANA Life Science Services, LLC建立合作伙伴关系,以支持美国纤维肌痛管理候选产品Tonmya™ 的推出和商业规划。Tonix计划在2024年下半年向美国食品药品管理局提交Tonmya的新药申请,此前两项3期试验取得了具有统计意义的结果。该公司还计划在2024年第二季度与美国食品药品管理局举行B型保密协议前会议。Tonmya,也被称为 TNX-102 SL,是一种非阿片类中枢作用的镇痛药,在临床试验中显示出明显的疼痛减轻和睡眠质量、疲劳和整体纤维肌痛症状的改善。
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