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Tonix Pharmaceuticals Holding Corp - TNXP STOCK NEWS

Welcome to our dedicated news page for Tonix Pharmaceuticals Holding (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceuticals Holding.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Tonix Pharmaceuticals Holding's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Tonix Pharmaceuticals Holding's position in the market.

News
New Hope For Fibromyalgia Patients: Tonix Details Results Of Second Successful Phase 3 Trial And Plans To File For FDA Approval
Rhea-AI Summary
Tonix Pharmaceuticals (NASDAQ:TNXP) has a potential new treatment for fibromyalgia with TNX-102 SL, hitting the primary endpoint of daily pain reduction with a p-value of 0.00005. TNX-102 SL targets poor sleep quality rather than sleep quantity, improving the daily lives of fibromyalgia patients. The company plans to file an NDA for FDA approval in the second half of 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.25%
Tags
clinical trial fda approval
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News
Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibromyalgia-Type Symptoms May Increase the Risk of Developing Long COVID
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. announces the publication of a research paper in the Journal Pain, revealing that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID. The study found that COPCs and Long COVID likely result from the same or similar brain processes, and Long COVID can be conceptualized as a new onset COPC or an exacerbation of a pre-existing COPC. The company is studying TNX-102 SL for the management of fibromyalgia and management of fibromyalgia-type Long COVID. Tonix has plans to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for the management of fibromyalgia.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
3.23%
Tags
covid-19
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News
Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. announced positive results from two Phase 3 studies for Tonmya (TNX-102 SL) in managing fibromyalgia, with plans to submit a New Drug Application to the FDA in the second half of 2024. The studies showed statistically significant reduction in daily pain and improvement in sleep quality, fatigue, and overall fibromyalgia symptoms. The FDA conditionally accepted the trade name Tonmya for TNX-102 SL, marking a significant step forward for the company in offering the first FDA-approved drug for fibromyalgia patients in more than a decade.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.67%
Tags
none
News
Tonix Pharmaceuticals Announces KOL Webinar to Discuss Positive Phase 3 Fibromyalgia Data, Sponsored by A.G.P.
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of TNX-102 SL for the management of fibromyalgia. The webinar will feature two esteemed thought leaders in the field of fibromyalgia and will be hosted by Alliance Global Partners. The webinar will take place on January 31, 2024, at 1:00 p.m. ET.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
10.71%
Tags
clinical trial
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News
Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (TNXP) announced the positive results from the Phase 3 RESILIENT study of TNX-102 SL for the management of fibromyalgia. The study met its primary endpoint with a statistically significant reduction in daily pain compared to placebo. The results also showed favorable tolerability and side effect profiles, including improvement in female sexual function and no increases in weight or blood pressure. The company plans to submit a New Drug Application to the FDA in the second half of 2024 under the 505(b)(2) regulatory pathway.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-11.42%
Tags
clinical trial
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News
Tonix Pharmaceuticals to Present at Two Upcoming Investor Conferences in January: Focus is on TNX-102 SL for the Management of Fibromyalgia Following Positive Topline Results in Second Pivotal Phase 3 Trial
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced positive results from a Phase 3 trial for TNX-102 SL, a non-opioid analgesic, and plans to submit a New Drug Application to the FDA in the second half of 2024. The company also shared updates on its various development candidates for central nervous system disorders, rare diseases, immunology, and infectious diseases, as well as its marketed products Zembrace SymTouch and Tosymra.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-7.14%
Tags
conferences clinical trial
News
Tonix Pharmaceuticals Announces Registered Direct Offering of up to $144 Million
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) secures $30 million upfront financing with potential for an additional $114 million tied to warrants exercise. The company signed securities purchase agreements with healthcare-focused institutional investors, aiming to raise up to $144 million in gross proceeds through a registered direct offering.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-36.67%
Tags
offering
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News
Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia met its primary endpoint, demonstrating daily pain reduction over placebo (p = 0.00005) and all six key secondary endpoints were significantly improved. Positive results support planned New Drug Application (NDA) submission to the FDA in the second half of 2024. The study showed statistically significant and clinically meaningful results in improving sleep quality, reducing fatigue, and overall fibromyalgia symptoms and function. TNX-102 SL is a novel, centrally-acting, non-opioid analgesic, designed for once daily use at bedtime for fibromyalgia management. The estimated 6 million to 12 million U.S. adults living with fibromyalgia, the majority of whom are women, could benefit from this treatment.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-36.67%
Tags
clinical trial
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News
Hope On The Horizon: Tonix Pharmaceuticals (NASDAQ:TNXP) Could Be On the Cusp of Changing Fibromyalgia Treatment Options With TNX-102 SL
Rhea-AI Summary
Fibromyalgia Therapeutics PLC (FTPL) is set to release topline data from a Registration-Enabling Phase 3 Clinical Trial later this month.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
21.43%
Tags
none
News
Tonix Pharmaceuticals to Present at The National Academies Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures Public Meeting
Rhea-AI Summary
Tonix Pharmaceuticals Holding Corp. (TNXP) to present at the National Academies of Sciences, Engineering, and Medicine Committee on the Current State of Research, Development, and Stockpiling of Smallpox Medical Countermeasures public meeting. The company's CEO, Dr. Seth Lederman, will participate in a panel discussion on Vaccine Research & Development to inform an evaluation of the current state of smallpox readiness and response measures.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.5%
Tags
conferences
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Tonix Pharmaceuticals Holding Corp

Nasdaq:TNXP

TNXP Rankings

#5236 Ranked by Market Cap
#5322 Ranked by Stock Gains
N/A Ranked by Dividends

TNXP Stock Data

15.53M
84.49M
0.01%
19.85%
1.7%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
United States
Chatham

About TNXP

tonix is developing innovative pharmaceutical products to address major public health challenges. in addition to tonmya for ptsd, tonix is developing tnx-601 (tianeptine oxalate), a clinical candidate at pre-ind (investigational new drug) application stage, designed as a daytime treatment for ptsd and tnx-801, a live synthetic version of horsepox virus, at the pre-ind application stage, to be developed as a potential smallpox-preventing vaccine. further information about tonix can be found at www.tonixpharma.com.