Tonix Pharmaceuticals Announces Poster Presentation at the Annual European Congress of Rheumatology (EULAR) 2024
Tonix Pharmaceuticals announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna, Austria, from June 12-15, 2024. The presentation will showcase statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for fibromyalgia management. Tonix plans to submit a New Drug Application (NDA) to the FDA in the second half of 2024. The company's portfolio focuses on CNS disorders, with products like TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix also markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.
- Statistically significant Phase 3 results for Tonmya™ (TNX-102 SL) in fibromyalgia management.
- NDA submission to the FDA planned for the second half of 2024.
- Diverse development portfolio targeting CNS disorders, autoimmunity, and oncology, potentially mitigating risk.
- Breakthrough Therapy designation for TNX-1300 for cocaine intoxication.
- Commercially available products like Zembrace® SymTouch® and Tosymra® for acute migraine treatment provide immediate revenue streams.
- Tonmya™ (TNX-102 SL) and other product candidates are not yet approved for any indication, which poses a risk to future revenue streams.
- The success of the NDA submission is not guaranteed, and delays or rejections could impact stock performance.
- Continuous investment in R&D without immediate returns could strain financial resources.
Insights
Tonmya™ (TNX-102 SL) achieving statistically significant Phase 3 results for fibromyalgia is noteworthy. Statistical significance in clinical trials means the results are unlikely due to chance, indicating the treatment's real effect. This strongly positions Tonmya for a successful New Drug Application (NDA) with the FDA. The FDA approval, expected in the second half of 2024, could open the doors to a substantial market.
Fibromyalgia, a condition characterized by widespread pain and fatigue, lacks many effective treatments, so an FDA-approved medication could meet a significant unmet need. Investors should watch for any updates on the NDA submission process, as regulatory milestones often lead to stock price movements.
In the short term, the positive Phase 3 results could boost investor confidence, while long-term success hinges on FDA approval and market adoption. The announcement indicates Tonix's commitment to advancing their pipeline, which includes treatments for other CNS disorders and conditions like acute stress reaction and Long COVID.
From a financial perspective, the successful Phase 3 trial results enhance Tonix's valuation. Developing a new drug typically requires significant investment and positive Phase 3 results reduce the risks associated with these investments. The announcement of on-track NDA submission in the second half of 2024 is critical, as regulatory approval can significantly impact revenue streams.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) currently trades on the belief in its pipeline potential. FDA approval for Tonmya can lead to revenue generation, potentially transforming Tonix from a development-stage company to one with marketable products. This transition often brings increased investor interest and higher stock valuations.
Investors should consider Tonix's financial health, including cash reserves and burn rate, to evaluate whether it can sustain operations until revenue from Tonmya materializes. Monitoring upcoming earnings reports and any additional funding activities will provide insight into the company's financial strategy and stability.
Presentation to highlight statistically significant Phase 3 results of Tonmya™ (TNX-102 SL) for the management of fibromyalgia
New Drug Application (NDA) submission to the FDA on track for the second half of 2024
CHATHAM, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2024, being held June 12-15, 2024 at the Messe Wien Congress Center in Vienna, Austria. Details on the presentation can be found below.
A copy of the Company’s poster presentations 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 EULAR website here.
Poster Presentation Details
| Presenter: | Iredell Iglehart, M.D. |
| Title: | Targeting Non-Restorative Sleep in Fibromyalgia with Bedtime TNX-102 SL (Sublingual Cyclobenzaprine HCl) Significantly Improves Pain in RESILIENT, a Confirmatory Phase 3 Randomized Clinical Trial |
| Room: | Poster Tour 2 |
| Abstract: | POS0324 |
| Date/Time: | Friday, June 14, 2024, 12:36 p.m. CEST |
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated 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 statistically significant 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 that has 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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
Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151
FAQ
What are the Phase 3 results for Tonmya™ (TNX-102 SL) presented at EULAR 2024?
When will Tonix submit the NDA for Tonmya™ (TNX-102 SL) to the FDA?
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What commercial products does Tonix currently market?
What is the focus of Tonix's development portfolio?
