Tonix Pharmaceuticals Presents TNX-102 SL at January Conferences Post Phase 3 Success

Tonix Pharmaceuticals, a biopharmaceutical firm, has reported promising results from a Phase 3 trial of TNX-102 SL, a non-opioid pain reliever. The medication has shown significant daily pain reduction compared to a placebo, with a p-value of 0.00005, meeting the primary endpoint. Moreover, it demonstrated positive outcomes across all six key secondary endpoints. Following these results, Tonix plans to submit a New Drug Application (NDA) to the FDA in 2024's second half.

The company's President and CEO, Seth Lederman, M.D., is scheduled to present at two upcoming investor conferences in January 2024. These include the 7th Annual Neuroscience Innovation Forum and the 2024 Biotech Showcase, both taking place in San Francisco. Investors interested in meeting with Tonix's management can coordinate through the respective event organizers. Webcasts of the presentations will be available on the company's website.

Tonix is dedicated to the development and commercialization of therapeutics for a range of human diseases, with a particular focus on central nervous system disorders. The company's lead candidate, TNX-102 SL, has completed two successful Phase 3 trials for fibromyalgia management and is also being developed to address fibromyalgia-type Long COVID. Tonix intends to meet with the FDA in early 2024 and aims to submit an NDA for TNX-102 SL's approval later in the year.

In addition to TNX-102 SL, Tonix has a diverse pipeline. TNX-1300 is a biologic designed to counter cocaine intoxication and has received the FDA's Breakthrough Therapy designation. A Phase 2 study for this drug is anticipated to commence in early 2024. The company's rare disease portfolio includes TNX-2900 for Prader-Willi syndrome, which has been granted Orphan Drug status by the FDA. Tonix is also developing immunology and infectious disease treatments, such as TNX-1500, a monoclonal antibody targeting CD40-ligand, and vaccines like TNX-801 for smallpox and mpox, and TNX-1800 for COVID-19.

Tonix Medicines, the company's commercial arm, markets Zembrace® SymTouch® and Tosymra®, acquired from Upsher-Smith Laboratories, for the treatment of acute migraines in adults.

It is important to note that Tonix's product candidates are still under investigation and have not yet received regulatory approval for any medical use. The company's trademarks, Zembrace SymTouch and Tosymra, are registered, while other marks belong to their respective owners.