Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, released key data during the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems. According to the announcement, the company was slated to participate in the three-day event with two oral presentations and a poster presentation. The conference was held Sept. 19–21, 2024, in Rome. The company noted that the presentations highlighted the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL (sublingual cyclobenzaprine HCl).
In addition, the announcement observed that composition and methods patents based on the eutectic formulation of TNX-102 SL should provide market exclusivity in the United States, European Union, Japan, China and other jurisdictions until at least 2034. Tonix also reported that the U.S. FDA New Drug Application (“NDA”) submission is on track for next month while results from its phase 3 RESILIENT study of TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality.
To view the presentations, visit https://ibn.fm/694La
To view the full press release, visit https://ibn.fm/YXJYl
About 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 priority is to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in October 2024 for TNX-102 SL, a product candidate for which two statistically significant phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix recently announced the U.S. Department of Defense (“DoD”), Defense Threat Reduction Agency (“DTRA”) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (“OTA”) to develop TNX-4200 small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Maryland. The company’s Good Manufacturing Practice (“GMP”)-capable advanced manufacturing facility in Dartmouth, Maryland, was purpose built to manufacture TNX-801 (live horsepox vaccine) for the prevention of mpox and other vaccines on the horsepox platform. The GMP suites are ready to be reactivated in case of a national or international emergency. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in phase 2 development 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, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R)(sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about the company, please visit www.TonixPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP
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