Tonix Pharmaceuticals Announces Presentation at The 6th International Congress on Controversies in Fibromyalgia
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The announcement from Tonix Pharmaceuticals regarding the additional data from the Phase 3 RESILIENT trial of Tonmya™ for fibromyalgia management is a significant development. The progress towards submitting a New Drug Application (NDA) to the FDA is a critical milestone that can potentially lead to increased investor confidence and a positive impact on the company's stock valuation. The dual utility of TNX-102 SL for treating both fibromyalgia and fibromyalgia-type Long COVID could expand the addressable market, providing a competitive edge in the CNS disorder treatment domain.
Considering the company's diverse portfolio, including TNX-1300 with Breakthrough Therapy designation for cocaine intoxication, there is a clear strategic focus on CNS disorders and immunology, which might attract investors interested in these healthcare segments. However, it's important to note that the success of these candidates is contingent upon regulatory approvals and market acceptance. The market potential for these treatments, especially given the chronic nature of CNS disorders and the current opioid crisis, could be substantial, but it is also subject to the usual risks associated with drug development, including clinical trial outcomes and regulatory hurdles.
The additional data from the RESILIENT trial is pivotal for medical professionals and investors alike, as it provides further evidence of Tonmya™'s efficacy and safety in managing fibromyalgia, a condition with limited effective treatment options. The potential FDA submission in the latter half of 2024 signifies a near-term catalyst that could have a significant impact on the company's future revenue streams. The mention of TNX-102 SL's development for acute stress reaction and Long COVID-related fibromyalgia suggests that Tonix is strategically positioning itself in the post-pandemic healthcare landscape, which could have far-reaching implications in terms of public health and economic outcomes.
Additionally, the development of TNX-1500 for preventing allograft rejection and treating autoimmune diseases reflects the company's commitment to addressing unmet medical needs. The success of these candidates would not only benefit patients but could also lead to substantial market growth for Tonix, provided they navigate the clinical and regulatory pathways successfully.
The CNS disorder treatment market is highly competitive, with several major pharmaceutical companies vying for market share. Tonix's focus on a diversified CNS and immunology portfolio positions it well to tap into multiple facets of this market. The positive trial results for Tonmya™ and its potential FDA submission could be a game-changer for the company, as fibromyalgia affects a significant portion of the population, creating a sizeable market opportunity.
Moreover, the company's commercial subsidiary's marketing of acute migraine treatments adds an operational revenue stream that complements its development pipeline. This balanced approach between marketed products and development candidates could provide financial stability and fund further research and development activities. The long-term impact on the stock market will depend on the timely approval of Tonmya™ and the successful commercialization of the company's product candidates.
Additional data from recently reported positive Phase 3 RESILIENT trial will be presented
CHATHAM, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present at The 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium on March 7, 2024. The presentation will include additional data from the recently reported positive Phase 3 RESILIENT trial of Tonmya™ (also known as TNX-102 SL) for the management of fibromyalgia.
A copy of the Company’s presentation will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the conference website.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
1Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495
FAQ
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