Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented positive Phase 3 RESILIENT data for TONMYA (sublingual cyclobenzaprine HCl) at the 2026 Non-Opioid Pain Therapeutics Summit on January 29, 2026.
In a 14-week, 456-participant randomized double-blind trial, TONMYA produced a statistically significant reduction in weekly average pain at Week 14 (p<0.0001; effect size 0.38) and significant improvements in sleep, fatigue, and Fibromyalgia Impact Questionnaire domains. TONMYA was approved by the FDA on August 15, 2025, and was generally well tolerated with low weight and blood pressure effects.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman, M.D. will present and host investor meetings at two January 2026 conferences in San Francisco: Sachs Associates 9th Annual Neuroscience Innovation Forum on Jan 11, 2026 (presentation 11:55 a.m. PT; panel 1:15 p.m. PT) and Biotech Showcase on Jan 13, 2026 (presentation 11:00 a.m. PT). A replay will be posted on the company website and investor meetings can be requested via sebastian.gomez@astrpartners.com.
Company highlights: marketed products TONMYA for fibromyalgia, Zembrace SymTouch and Tosymra for acute migraine, plus a CNS, immunology, rare disease and infectious disease pipeline including TNX-102 SL, TNX-1500, TNX-2900, TNX-801, TNX-4800 and TNX-4200 (DTRA contract up to $34M).
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a registered direct offering with Point72 to purchase 615,025 shares of common stock or pre-funded warrants at $16.26 per share (or $16.259 per pre-funded warrant), generating approximately $20.0 million gross proceeds before fees. The closing is expected on or about December 30, 2025, subject to customary conditions. Net proceeds are intended to fund commercialization of marketed products, development of the product pipeline, and general working capital. TD Cowen is sole placement agent; A.G.P./Alliance Global Partners is financial advisor. The offering is on an effective Form S-3 registration.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced program updates for TNX-4800, a long-acting human monoclonal antibody targeting OspA for seasonal Lyme disease prevention.
The company plans an FDA meeting in 2026 to explore Phase 2/3 options including a controlled human infection model (CHIM) and an adaptive Phase 2/3 field study. Tonix expects GMP investigational product to be available for clinical testing in early 2027. The company estimates ~70 million people in U.S. Lyme-endemic areas could potentially benefit. The release notes there are no currently marketed FDA-approved vaccines or prophylactics for Lyme disease and describes TNX-4800 as providing near-immediate immunity after one subcutaneous dose for seasonal protection.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced exclusive worldwide licensing of TNX-4900, a selective small-molecule Sigma-1 receptor antagonist for chronic neuropathic pain, on December 16, 2025. TNX-4900 binds human S1R with Ki = 7.5 nM, shows >100-fold selectivity over Sigma-2, and demonstrates high blood-brain barrier penetration and oral bioavailability of ~28%. In animal models of diabetic and chemotherapy-induced neuropathic pain, TNX-4900 produced significant, durable analgesia after acute and chronic dosing without tolerance or motor impairment. Tonix plans expanded PK, formulation, and safety studies to support IND-enabling development.
Tonix Pharmaceuticals (Nasdaq: TNXP) appointed Irina Ishak as General Counsel, effective Dec 8, 2025. Ishak brings more than 25 years of corporate legal and life sciences experience and will lead legal, governance, and compliance functions. She previously served as Senior Counsel at Lowenstein Sandler since 2013 and advised Tonix since 2017 on financings, licensing, commercial agreements, and board matters.
The appointment coincides with Tonix commercializing FDA-approved TONMYA (first new fibromyalgia drug in >15 years) and advancing a diversified CNS, immunology, rare disease, and infectious disease pipeline.
Tonix Pharmaceuticals (NASDAQ: TNXP) announced FDA clearance of an IND to support clinical development of TNX-102 SL 5.6 mg for adults with major depressive disorder (MDD). The IND enables a potentially pivotal Phase 2 HORIZON study: a 6-week, randomized, double-blind, placebo-controlled trial enrolling ~360 patients at ~30 US sites, with primary endpoint of MADRS total score change at Week 6. Tonix plans to begin enrollment in mid-2026. Prior TNX-102 SL studies in fibromyalgia and PTSD showed signals of depressive-symptom improvement on BDI-II and MADRS. The program targets disturbed sleep associated with depression and the company reports prior tolerability data from fibromyalgia registrational studies.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that TONMYA™ (cyclobenzaprine HCl sublingual tablets) is now commercially available by prescription in U.S. pharmacies as of Nov 17, 2025. TONMYA is presented as a first‑in‑class, non‑opioid, once‑daily bedtime analgesic for adults with fibromyalgia and is the first FDA‑approved fibromyalgia treatment in more than 15 years.
The FDA approved TONMYA on Aug 15, 2025 based on two double‑blind Phase 3 trials (nearly 1,000 patients) showing a significant reduction in daily pain at 14 weeks and a higher percentage achieving ≥30% pain improvement; three Phase 3 trials (> 1,400 patients) reported overall tolerability and listed common adverse events.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported third-quarter 2025 results and operational highlights on Nov 10, 2025. Key commercial news: Tonmya (cyclobenzaprine HCl sublingual) received FDA approval as the first new fibromyalgia medicine in >15 years and is set to launch in November 2025 with a WAC established and field sales in place.
Financials: $190.1M cash as of Sept 30, 2025 and a cash runway expected to fund operations into Q1 2027. Q3 product revenue was $3.3M versus $2.8M a year earlier. Q3 net loss was $32.0M (loss per share $3.59) with 8.92M weighted average shares outstanding.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman, M.D., will present at the Stifel 2025 Healthcare Conference on Thursday, November 13, 2025 at 10:00 AM ET. A live webcast will be available on the company's Investors Events page, with a replay accessible for 90 days after the event. Investors seeking meetings should contact their Stifel representative.
Business highlights: Tonix is a commercial biotechnology company with FDA approval for TONMYA for fibromyalgia, marketed acute migraine treatments, a CNS and immunology pipeline (including TNX-102 SL, TNX-1500, TNX-2900, TNX-801, TNX-4800) and a DTRA contract for TNX-4200 of up to $34 million over five years.