TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasd...
Tonix Pharmaceuticals is preparing for the commercial launch of Tonmya, a new FDA-approved fibromyalgia therapy, in November 2025. 3Q25 results showed revenue growth and a strong cash position, but higher SG&A expenses reflect heavy investment in commercialization efforts. Key risks for TNXP include patient adoption challenges and uncertainties around insurance coverage and payer reimbursement ...
Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027 CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE)...
Planning to initiate an open-label Phase 2 study of TNX-1500 under an investigator-initiated IND to evaluate safety and activity in the first half of 2026
CHATHAM, N.J., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biopharmaceutical company announced today that Seth Lederman, M.D.
Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study Treatment was well tolerated with minimal effects on weight or blood pressure and discontinuation rate of 19% vs. placebo of 20.8% Data support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic and therapeutic option for adults with fibromyalgia
FOCUS is a randomized, double-blind, placebo-controlled crossover pilot study evaluating Tonix's investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D) The trial is intended to generate preliminary data to inform future potential clinical studies of oxytocin replacement therapy in AVP-D
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