牛牛AI助理已提取核心訊息
On January 29, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) conditionally accepted the trade name Tonmya™ for its TNX-102 SL product candidate, aimed at managing fibromyalgia. This announcement follows the release of positive results from two Phase 3 studies, RESILIENT and RELIEF, which demonstrated the drug's potential as a first-line treatment for fibromyalgia, a condition affecting 6-12 million adults in the U.S. Tonix plans to submit a New Drug Application (NDA) for Tonmya in the second half of 2024 under the 505(b)(2) regulatory pathway. The company's CEO, Seth Lederman, expressed satisfaction with the FDA's decision and optimism about Tonmya's potential to be the first FDA-approved drug for fibromyalgia in over a decade. Tonix Pharmaceuticals, with a focus on central nervous system disorders, also has other candidates in development for various conditions, including fibromyalgia-type Long COVID and cocaine intoxication.
On January 29, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) conditionally accepted the trade name Tonmya™ for its TNX-102 SL product candidate, aimed at managing fibromyalgia. This announcement follows the release of positive results from two Phase 3 studies, RESILIENT and RELIEF, which demonstrated the drug's potential as a first-line treatment for fibromyalgia, a condition affecting 6-12 million adults in the U.S. Tonix plans to submit a New Drug Application (NDA) for Tonmya in the second half of 2024 under the 505(b)(2) regulatory pathway. The company's CEO, Seth Lederman, expressed satisfaction with the FDA's decision and optimism about Tonmya's potential to be the first FDA-approved drug for fibromyalgia in over a decade. Tonix Pharmaceuticals, with a focus on central nervous system disorders, also has other candidates in development for various conditions, including fibromyalgia-type Long COVID and cocaine intoxication.
2024年1月29日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局（FDA）有條件地接受了其旨在控制纖維肌痛的 TNX-102 SL 候選產品的商品名 Tonmya™。該公告是在兩項3期研究（RESILIENT和REILEIF）公佈積極結果之後發佈的，這兩項研究表明該藥物有可能作爲纖維肌痛的一線治療方法，這種疾病影響着美國600萬至1200萬成年人。Tonix計劃在2024年下半年根據505（b）（2）監管途徑提交Tonmya的新藥申請（NDA）。該公司首席執行官塞思·萊德曼對美國食品藥品管理局的決定表示滿意，並對Tonmya有可能成爲十多年來第一種獲得美國食品藥品管理局批准的纖維肌痛藥物表示樂觀。Tonix Pharmicals專注於中樞神經系統疾病，還有其他針對各種疾病的候選藥物正在開發中，包括纖維肌痛型長冠狀病毒和可卡因中毒。
2024年1月29日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局（FDA）有條件地接受了其旨在控制纖維肌痛的 TNX-102 SL 候選產品的商品名 Tonmya™。該公告是在兩項3期研究（RESILIENT和REILEIF）公佈積極結果之後發佈的，這兩項研究表明該藥物有可能作爲纖維肌痛的一線治療方法，這種疾病影響着美國600萬至1200萬成年人。Tonix計劃在2024年下半年根據505（b）（2）監管途徑提交Tonmya的新藥申請（NDA）。該公司首席執行官塞思·萊德曼對美國食品藥品管理局的決定表示滿意，並對Tonmya有可能成爲十多年來第一種獲得美國食品藥品管理局批准的纖維肌痛藥物表示樂觀。Tonix Pharmicals專注於中樞神經系統疾病，還有其他針對各種疾病的候選藥物正在開發中，包括纖維肌痛型長冠狀病毒和可卡因中毒。
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