Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, has completed the clinical stage of its phase 1 single ascending dose escalation trial, designed to evaluate TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb) in healthy volunteers. According to the announcement, the company anticipates receiving topline results from the trial in Q3 2024 and is now planning a phase 2 trial focused on evaluating the drug for prevention of kidney transplant rejection.
In addition, Tonix Pharmaceuticals CEO Seth Lederman, MD, was featured in two releases from Proactive, a best-in-class media provider of 24/7 breaking news, commentary and analysis on hundreds of listed and pre-IPO companies around the globe. In the videos Lederman and Proactive host Steve Darling discuss two key news releases from Tonix: positive results from a phase 3 study on Tonmya, also known as TNX-102 SL, for the management of fibromyalgia, and the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the company’s phase 2 investigator-initiated OASIS trial.
To view the videos, visit https://ibn.fm/yiFou and https://ibn.fm/66mmh.
To view the full press releases, visit https://ibn.fm/tjE3X, https://ibn.fm/XFUBN and https://ibn.fm/HktND.
About 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 U.S. Food and Drug Administration in the second half of 2024 for Tonmya, 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, 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.
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