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The FDA typically has a 60-day window to determine if the submitted NDA is acceptable for review. If accepted, the FDA will issue a Prescription Drug User Fee Act  date for a decision on approval, which we anticipate being in August 2025 for a standard review or April 2025 for priority review. TNX-102 SL was previously granted Fast Track designation by the FDA in July 2024, making it eligible for priority review, however that is not determined by the FDA until acceptance of the NDA.","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/KUgYeMEXwVPR9UEOpfbqJg--~B/aD03ODg7dz0xMzk2O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/scr.zacks.com/f0d0fa1979251d8fabfe1285ca18a24e","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/KUgYeMEXwVPR9UEOpfbqJg--~B/aD03ODg7dz0xMzk2O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/scr.zacks.com/f0d0fa1979251d8fabfe1285ca18a24e"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/tnxp-nda-filed-tnx-102-102500471.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4585","LU0048573645.USD","TNXP","LU0532188223.SGD","SG9999002604.SGD","BK4535","LU0234570918.USD","LU0889565916.HKD","SG9999006266.SGD","LU0210637038.USD","BK4077","BK4533","SLE","BK4085","LU0320765992.SGD","SG9999004360.SGD","BK4503","LU2125910500.SGD","LU0737861269.HKD","SG9999002406.SGD","SG9999013486.USD","BK4581","SG9999002679.SGD","BK4588","SG9999013478.USD","LU2045819591.USD","SG9999014492.USD","IE00B19Z9P08.USD","LU0261945553.USD","SG9999002414.USD","BK4566","BK4548","BK4139","SG9999002620.SGD","BK4532","BK4583","BIIB","BK4551","IE00B19Z9Z06.USD","LU0109394709.USD","LU0251143029.SGD","SG9999001135.SGD","SG9999014484.SGD","SGXZ58947870.SGD","SG9999013460.SGD","IE00B894F039.SGD","BK4554","IE0034224299.USD","SG9999005177.SGD"],"gpt_icon":1},{"id":"2486071647","title":"Tonix Pharmaceuticals to Participate in the NobleCon20 Investor Conference","url":"https://stock-news.laohu8.com/highlight/detail?id=2486071647","media":"GlobeNewswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486071647?lang=en_us&edition=fundamental","pubTime":"2024-11-26 20:00","pubTimestamp":1732622400,"startTime":"0","endTime":"0","summary":"CHATHAM, N.J., Nov.  26, 2024  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2024/11/26/2987334/28908/en/Tonix-Pharmaceuticals-to-Participate-in-the-NobleCon20-Investor-Conference.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4583","BK4135","CNS","BK4139","TNXP"],"gpt_icon":1},{"id":"2484115825","title":"Top Premarket Gainers","url":"https://stock-news.laohu8.com/highlight/detail?id=2484115825","media":"MT Newswires 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Virtual","url":"https://stock-news.laohu8.com/highlight/detail?id=2484989639","media":"GlobeNewswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484989639?lang=en_us&edition=fundamental","pubTime":"2024-11-19 05:05","pubTimestamp":1731963900,"startTime":"0","endTime":"0","summary":"CHATHAM, N.J., Nov. 18, 2024  -- Tonix Pharmaceuticals Holding Corp.  , a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the Winter 2024 Investor Summit Virtual on Thursday, November 21, 2024, at 10:00 a.m. ET.","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/x8OenoHLlZtilFbGLk.hYQ--~B/aD0zODA7dz04MTU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/globenewswire.com/2260880378e4d1a1a54ac9ee6eda14bf","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/x8OenoHLlZtilFbGLk.hYQ--~B/aD0zODA7dz04MTU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/globenewswire.com/2260880378e4d1a1a54ac9ee6eda14bf"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/tonix-pharmaceuticals-present-winter-2024-210500777.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4583","BK4135","TNXP","BK4139","CNS","SMMF","BK4211"],"gpt_icon":1},{"id":"2484621444","title":"Tonix Pharmaceuticals presents data, analyses of TNX-102 SL effects","url":"https://stock-news.laohu8.com/highlight/detail?id=2484621444","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484621444?lang=en_us&edition=fundamental","pubTime":"2024-11-18 20:30","pubTimestamp":1731933046,"startTime":"0","endTime":"0","summary":"Tonix Pharmaceuticals (TNXP) presented data in a poster presentation at the ACR Convergence 2024 Annual Meeting, held November 14-19, 2024, in Wash...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/tonix-pharmaceuticals-presents-data-analyses-of-tnx-102-sl-effects?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/tonix-pharmaceuticals-presents-data-analyses-of-tnx-102-sl-effects?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["TNXP","BK4139","BK4583"],"gpt_icon":0},{"id":"2484589626","title":"Press Release: Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting","url":"https://stock-news.laohu8.com/highlight/detail?id=2484589626","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484589626?lang=en_us&edition=fundamental","pubTime":"2024-11-18 20:00","pubTimestamp":1731931200,"startTime":"0","endTime":"0","summary":"Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology  Convergence 2024 Annual Meeting. Poster presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL  treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality. New Drug Application  submitted to FDA in October 2024; Fast Track designation previously granted by FDA; FDA decision on approval expected 2025. TNX-102 SL is a potential non-opioid analgesic targeting non-restorative sleep. Tonix submitted a new drug application  to the U.S. Food and Drug Administration  in October 2024 for TNX-102 SL for the management of fibromyalgia. The FDA typically has a 60-day filing review period to determine whether the submitted NDA is complete and ac","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4135","AFG","BK4110","BK4117","ACR","BK4583","BK4107","BK4139","TNXP","CNS"],"gpt_icon":1},{"id":"2483872901","title":"Tonix Pharmaceuticals Targets Rapid Migraine Relief With Non-Oral Treatments","url":"https://stock-news.laohu8.com/highlight/detail?id=2483872901","media":"ACCESSWIRE","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483872901?lang=en_us&edition=fundamental","pubTime":"2024-11-14 20:30","pubTimestamp":1731587400,"startTime":"0","endTime":"0","summary":"This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.CHATHAM, NJ / ACCESSWIRE / November 14, 2024 / For millions of people living with migraines, the pain can strike without warning, often during the most inconvenient times-like when they are fast asleep. The abrupt transition from sleep to a full-blown migraine leaves little room for preemptive action, especially when traditional oral migraine medications can take half an hour to an hour, or even more, to work.But for those seeking immediate relief, Tonix Pharmaceuticals  is hoping to change the game. Through its subsidiary, Tonix Medicines, the biopharmaceu","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/PnKmZFC0zVvhS5pD6mDpow--~B/aD00NjQ7dz02OTc7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/accesswire.ca/6c0847038100b914834ba713fad1e87c","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/PnKmZFC0zVvhS5pD6mDpow--~B/aD00NjQ7dz02OTc7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/accesswire.ca/6c0847038100b914834ba713fad1e87c"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/tonix-pharmaceuticals-targets-rapid-migraine-123000577.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4135","BK4139","TNXP","BK4583","CNS"],"gpt_icon":0},{"id":"2483868143","title":"Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting","url":"https://stock-news.laohu8.com/highlight/detail?id=2483868143","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483868143?lang=en_us&edition=fundamental","pubTime":"2024-11-14 05:05","pubTimestamp":1731531900,"startTime":"0","endTime":"0","summary":"CHATHAM, N.J., Nov.  13, 2024  (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2024/11/13/2980651/28908/en/Tonix-Pharmaceuticals-Announces-Poster-Presentation-at-the-American-College-of-Rheumatology-ACR-Convergence-2024-Annual-Meeting.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4110","BK4135","TNXP","BK4117","BK4583","BK4107","AFG","CNS","BK4139","ACR"],"gpt_icon":1},{"id":"2483862348","title":"Tonix Pharmaceuticals announces publication of study on tolerability of TNX-801","url":"https://stock-news.laohu8.com/highlight/detail?id=2483862348","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483862348?lang=en_us&edition=fundamental","pubTime":"2024-11-13 22:10","pubTimestamp":1731507018,"startTime":"0","endTime":"0","summary":"Tonix Pharmaceuticals (TNXP) announced the publication of a paper entitled, “Recombinant Chimeric Horsepox Virus, TNX-801, is Attenuated Relative t...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/tonix-pharmaceuticals-announces-publication-of-study-on-tolerability-of-tnx-801?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/tonix-pharmaceuticals-announces-publication-of-study-on-tolerability-of-tnx-801?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4583","BK4139","TNXP"],"gpt_icon":0},{"id":"2483885165","title":"BRIEF-Tonix Pharmaceuticals Announces Peer-Reviewed Publication In Msphere Journal Highlighting The Tolerability Of Company’S Single-Dose Mpox And Smallpox Vaccine Candidate TNX-801, In Immune-Compromised Animals","url":"https://stock-news.laohu8.com/highlight/detail?id=2483885165","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483885165?lang=en_us&edition=fundamental","pubTime":"2024-11-13 22:06","pubTimestamp":1731506791,"startTime":"0","endTime":"0","summary":"Nov 13  - Tonix Pharmaceuticals Holding Corp :   * TONIX PHARMACEUTICALS ANNOUNCES PEER-REVIEWED PUBLICATION IN MSPHERE JOURNAL HIGHLIGHTING THE TOLERABILITY OF COMPANY’S SINGLE-DOSE MPOX AND SMALLPOX VACCINE CANDIDATE TNX-801, IN IMMUNE-COMPROMISED ANIMALS   * TONIX PHARMACEUTICALS HOLDING CORP - TNX-801 TOLERABILITY IN IMMUNE-COMPROMISED ANIMALS SUPPORTS CLINICAL DEVELOPMENTSource text:    Further company coverage:    ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4583","BK4139","TNXP"],"gpt_icon":1},{"id":"2483885119","title":"Tonix Pharmaceuticals Holding Corp - Tnx-801 Tolerability in Immune-Compromised Animals Supports Clinical Development","url":"https://stock-news.laohu8.com/highlight/detail?id=2483885119","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483885119?lang=en_us&edition=fundamental","pubTime":"2024-11-13 22:05","pubTimestamp":1731506700,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241113:nTUA9PB5KY:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4583","BK4139","TNXP"],"gpt_icon":0},{"id":"2483674885","title":"Tonix Pharmaceuticals Announces Peer-Reviewed Publication in Msphere Journal Highlighting the Tolerability of Company’s Single-Dose Mpox and Smallpox Vaccine Candidate Tnx-801, in Immune-Compromised Animals","url":"https://stock-news.laohu8.com/highlight/detail?id=2483674885","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483674885?lang=en_us&edition=fundamental","pubTime":"2024-11-13 22:05","pubTimestamp":1731506700,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241113:nTUA9PB5KY:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4583","TNXP","BK4139"],"gpt_icon":0},{"id":"2483688633","title":"Tonix Pharmaceuticals Announces Peer-Reviewed Publication in mSphere Journal Highlighting the Tolerability of Company’s Single-Dose Mpox and Smallpox Vaccine Candidate TNX-801, in Immune-Compromised Animals","url":"https://stock-news.laohu8.com/highlight/detail?id=2483688633","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483688633?lang=en_us&edition=fundamental","pubTime":"2024-11-13 22:05","pubTimestamp":1731506700,"startTime":"0","endTime":"0","summary":"The World Health Organization  declared the spread of new Clade Ib Mpox a public health emergency of international concern : Second Mpox-related WHO PHEIC declaration in two years. Clade Ib Mpox cases detected in 16 African countries and outside of Africa, in Sweden, Thailand, Singapore, India, Germany and England. Single-dose mpox vaccines with durable protection may be required to address global health emergency. TNX-801 was shown to be more than 10- to 1,000-fold more attenuated  compared to the older vaccinia smallpox vaccines: Tolerability of TNX801 vaccination in immune-compromised animal models supports clinical development. “Addressing the new Clade Ib mpox outbreak and the ongoing spread of Clade IIb mpox may require a single dose mpox vaccine that provides durable protection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 previously has demonstrated the ability to protect animals from lethal challenge with Clade Ia monkeypox virus. 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