Tonix recently reported results from second positive Phase 3 trial of Tonmya™ for the management of fibromyalgia
In the U.S., New Drug Application (NDA) submission to the FDA planned for the second half of 2024
In Japan, China and most countries in Europe cyclobenzaprine is a New Chemical Entity
CHATHAM, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2024 BIO-Europe Spring Convention being held March 18-20, 2024 in Barcelona, Spain. The presentation will take place on Tuesday, March 19, 2024 at 10:45 a.m. CET in Room 133/134 of the CCIB Barcelona.
To schedule a meeting with the Company's management at the convention, please submit a meeting request through the BIO One-on-One Partnering™ system or contact brandon.weiner@westwicke.com.
About Tonmya* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and ...