What's Going On With Tonix Pharmaceuticals Stock Today?
What's Going On With Tonix Pharmaceuticals Stock Today?
The NDA submission is supported by two Phase 3 studies — RELIEF and RESILIENT — that evaluated TNX-102 SL's safety and efficacy. Both trials met their primary endpoints, demonstrating a statistical reduction in daily pain compared to placebo. Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) shares are trading lower Tuesday after initially jumping after the company announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid. Here's what you need to know.
Tonix Pharmaceuticals Holding Corp (納斯達克:TNXP)的股票在週二交易中下跌，此前該公司宣佈美國食品和藥物管理局（FDA）接受了其針對TNX-102 SL（一種5.6毫克的非阿片類藥物）的新藥申請（NDA），該股價一度上漲。以下是您需要了解的內容。
What To Know: The FDA's acceptance of the NDA triggers a process in which the agency will assign a Prescription Drug User Fee Act (PDUFA) target action date and determine if the application qualifies for priority review, which will be communicated in the Day 74 Letter. TNX-102 SL was granted Fast Track designation by the FDA in July 2024.
需要了解的內容：FDA接受NDA後，將觸發一個流程，機構會爲處方藥用戶費用法案（PDUFA）分配一個目標行動日期，並判斷該申請是否符合優先審查的資格，這將在第74天的信函中進行傳達。TNX-102 SL於2024年7月獲得FDA的快速通道資格。
Fibromyalgia affects more than 10 million adults in the United States, with the majority being women. TNX-102 SL, if approved, could be the first new drug for treating fibromyalgia in over 15 years and the first member of a new class of analgesic drugs for the condition.
纖維肌痛症影響美國超過1000萬成年人，大多數爲女性。如果獲得批准，TNX-102 SL可能成爲15年來治療纖維肌痛症的第一種新藥，也是該病症新類別鎮痛藥的第一名成員。
The NDA submission is supported by two Phase 3 studies — RELIEF and RESILIENT — that evaluated TNX-102 SL's safety and efficacy. Both trials met their primary endpoints, demonstrating a statistical reduction in daily pain compared to placebo.
此NDA提交得到了兩項第三階段研究的支持 - RELIEF和RESILIENt，這兩項研究評估了TNX-102 SL的安全性和療效。兩項試驗都達到了其主要終點，顯示出與安慰劑相比日常疼痛有統計學上的顯著減少。
In the RELIEF study completed in December 2020, results showed significance with a p-value of 0.010. In the confirmatory RESILIENT trial completed in December 2023, significance was observed with a p-value of 0.00005. TNX-102 SL was generally well tolerated in both trials. The most common treatment-related adverse event was temporary numbness of the tongue or mouth at the administration site, which did not lead to significant study discontinuations.
在2020年12月完成的RELIEF研究中，結果顯示p值爲0.010，具有顯著性。在2023年12月完成的確認性RESILIENt試驗中，觀察到p值爲0.00005，具有顯著性。TNX-102 SL在兩項試驗中總體耐受性良好。最常見的治療相關不良事件是舌頭或口腔在給藥部位的暫時性麻木，並未導致顯著的研究中止。
Tonix Pharmaceuticals' CEO Seth Lederman noted that the fibromyalgia community has been waiting for a new drug for over 15 years and emphasized that, based on U.S. insurance claims data, fibromyalgia patients are more likely to be prescribed opioids than all three current FDA-approved drugs combined within 18 months of diagnosis.
Tonix Pharmaceuticals的首席執行官Seth Lederman指出，纖維肌痛症的社區已等待新藥超過15年，並強調根據美國的保險理賠數據，纖維肌痛症患者在診斷後的18個月內更可能被開具阿片類藥物處方，而不是所有三種當前FDA批准的藥物的總和。
Tonix is preparing for potential approval in 2025. The company noted that it already has a commercial leadership team in place. Tonix also markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for the acute treatment of migraine.
Tonix正在爲2025年潛在批准做準備。該公司表示，已設立商業領導團隊。Tonix還銷售Zembrace SymTouch（舒馬曲坦注射液）和Tosymra（舒馬曲坦鼻用噴霧劑）用於急性偏頭痛的治療。
TNXP Price Action: Tonix shares were up about 25% for the session at the time of writing, but had turned negative by publication time. At last check, Tonix shares were down 7.11% at 49 cents, according to Benzinga Pro.
TNXP價格動態：截至撰寫時，Tonix的股票上漲了大約25%，但在發佈時已轉爲負值。根據Benzinga Pro的最後檢查，Tonix的股票下跌了7.11%，當前價格爲49美分。
Image Via Shutterstock.
圖片來自Shutterstock。
