牛牛AI助理已提取核心訊息
On February 12, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 OASIS trial. The trial, sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, will evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in trauma survivors. The trial will enroll approximately 180 patients and aims to address the unmet need for treating ASR immediately after traumatic events. Tonix Pharmaceuticals also updated its investor presentation and intends to place it on its website. The company is focused on central nervous system disorders and is preparing to submit a New Drug Application (NDA) for Tonmya, a product candidate for the management of fibromyalgia, in the second half of 2024.
On February 12, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 OASIS trial. The trial, sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense, will evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in trauma survivors. The trial will enroll approximately 180 patients and aims to address the unmet need for treating ASR immediately after traumatic events. Tonix Pharmaceuticals also updated its investor presentation and intends to place it on its website. The company is focused on central nervous system disorders and is preparing to submit a New Drug Application (NDA) for Tonmya, a product candidate for the management of fibromyalgia, in the second half of 2024.
2024年2月12日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局（FDA）已批准OASIS二期試驗的研究性新藥（IND）申請。該試驗由北卡羅來納大學（UNC）創傷康復研究所贊助，並得到美國國防部300萬美元撥款的支持，將評估 TNX-102 SL 在降低創傷倖存者急性應激反應（ASR）的嚴重程度以及急性應激障礙（ASD）和創傷後應激障礙（PTSD）發生率方面的功效。該試驗將招收約180名患者，旨在解決創傷事件發生後立即治療ASR的未得到滿足的需求。Tonix Pharmicals還更新了其投資者介紹，並打算將其發佈在其網站上。該公司專注於中樞神經系統疾病，並準備在2024年下半年爲治療纖維肌痛的候選產品Tonmya提交新藥申請（NDA）。
2024年2月12日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局（FDA）已批准OASIS二期試驗的研究性新藥（IND）申請。該試驗由北卡羅來納大學（UNC）創傷康復研究所贊助，並得到美國國防部300萬美元撥款的支持，將評估 TNX-102 SL 在降低創傷倖存者急性應激反應（ASR）的嚴重程度以及急性應激障礙（ASD）和創傷後應激障礙（PTSD）發生率方面的功效。該試驗將招收約180名患者，旨在解決創傷事件發生後立即治療ASR的未得到滿足的需求。Tonix Pharmicals還更新了其投資者介紹，並打算將其發佈在其網站上。該公司專注於中樞神經系統疾病，並準備在2024年下半年爲治療纖維肌痛的候選產品Tonmya提交新藥申請（NDA）。
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