牛牛AI助理已提取核心訊息
On February 13, 2024, Tonix Pharmaceuticals Holding Corp. announced the engagement of Rho, Inc., a contract research organization, to assist with the preparation and planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tonmya™, a product candidate for the management of fibromyalgia. The announcement was made through a press release filed with the SEC as part of a Form 8-K report. Tonmya™, which is a sublingual tablet formulation of cyclobenzaprine hydrochloride, has shown statistically significant results in two Phase 3 trials. The company plans to meet with the FDA in the first half of 2024 and aims to submit the NDA in the second half of the year. Fibromyalgia, a chronic pain condition, affects approximately 10 million U.S. adults and is characterized by widespread pain, nonrestorative sleep, fatigue, and other symptoms. Current treatments often leave patients and physicians dissatisfied, highlighting the need for new therapeutic options. Tonix Pharmaceuticals is focused on central nervous system disorders and has a portfolio of development candidates in addition to Tonmya™.
On February 13, 2024, Tonix Pharmaceuticals Holding Corp. announced the engagement of Rho, Inc., a contract research organization, to assist with the preparation and planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tonmya™, a product candidate for the management of fibromyalgia. The announcement was made through a press release filed with the SEC as part of a Form 8-K report. Tonmya™, which is a sublingual tablet formulation of cyclobenzaprine hydrochloride, has shown statistically significant results in two Phase 3 trials. The company plans to meet with the FDA in the first half of 2024 and aims to submit the NDA in the second half of the year. Fibromyalgia, a chronic pain condition, affects approximately 10 million U.S. adults and is characterized by widespread pain, nonrestorative sleep, fatigue, and other symptoms. Current treatments often leave patients and physicians dissatisfied, highlighting the need for new therapeutic options. Tonix Pharmaceuticals is focused on central nervous system disorders and has a portfolio of development candidates in addition to Tonmya™.
2024年2月13日，Tonix Pharmicals Holding Corp. 宣佈聘請合同研究機構Rho, Inc. 協助準備和計劃向美國食品藥品監督管理局 (FDA) 提交纖維肌痛管理候選產品Tonmya™ 的新藥申請（NDA）。該公告是通過向美國證券交易委員會提交的新聞稿發佈的，該新聞稿是表格8-K報告的一部分。Tonmya™ 是鹽酸環苯扎林的舌下片劑配方，在兩項3期試驗中顯示出具有統計學意義的結果。該公司計劃在2024年上半年與美國食品藥品管理局會面，並計劃在下半年提交保密協議。纖維肌痛是一種慢性疼痛疾病，影響約1000萬美國成年人，其特徵是廣泛疼痛、睡眠無法恢復、疲勞和其他症狀。目前的治療往往會讓患者和醫生不滿意，這凸顯了對新治療選擇的需求。Tonix Pharmicals專注於中樞神經系統疾病，除Tonmya™ 外，還擁有一系列候選開發藥物。
2024年2月13日，Tonix Pharmicals Holding Corp. 宣佈聘請合同研究機構Rho, Inc. 協助準備和計劃向美國食品藥品監督管理局 (FDA) 提交纖維肌痛管理候選產品Tonmya™ 的新藥申請（NDA）。該公告是通過向美國證券交易委員會提交的新聞稿發佈的，該新聞稿是表格8-K報告的一部分。Tonmya™ 是鹽酸環苯扎林的舌下片劑配方，在兩項3期試驗中顯示出具有統計學意義的結果。該公司計劃在2024年上半年與美國食品藥品管理局會面，並計劃在下半年提交保密協議。纖維肌痛是一種慢性疼痛疾病，影響約1000萬美國成年人，其特徵是廣泛疼痛、睡眠無法恢復、疲勞和其他症狀。目前的治療往往會讓患者和醫生不滿意，這凸顯了對新治療選擇的需求。Tonix Pharmicals專注於中樞神經系統疾病，除Tonmya™ 外，還擁有一系列候選開發藥物。
有用
沒用