Tonix Pharmaceuticals Holding (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced participation at the 2024 BIO CEO & Investor Conference. According to the announcement, Tonix’s President and CEO, Seth Lederman, M.D., will present at the event, with his presentation scheduled for February 26, 2024, at 1:30 p.m. ET in New York City.
To view the full press release, visit https://ibn.fm/p9Sx1
About Tonix Pharmaceuticals Holding Corp.
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (“PWS”). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (“IND”) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes 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. A Phase 1 study of TNX-801 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (“NIH”), National Institute of Allergy and Infectious Diseases (“NIAID”) Project NexGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. For more information about Tonix, visit www.tonixpharma.com.
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