Tonix Pharmaceuticals

TNXP

Market cap $191M

Tonix Pharmaceuticals Holding Corp. received FDA approval and launched Tonmya, the first new fibromyalgia drug in over 15 years. TNXP is expanding Tonmya into acute stress disorder [ASD] and major depressive disorder [MDD], with key phase 2 trials underway or planned to initiate. The company maintains a strong cash position, supporting operations into 2027, but future capital raises may be needed to commercialize Tonmya and fund the rest of the TNXP pipeline.

Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026

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. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYATM (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies by prescription in the United States.

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 for Tonmya.

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) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent operational highlights.

CHATHAM, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced that Seth Lederman, M.D.

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