Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut stock.
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) 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.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a collaboration with Massachusetts General Hospital to initiate an investigator‑initiated, open‑label Phase 2 study of Fc‑modified anti‑CD40L mAb TNX‑1500 to prevent kidney transplant rejection.
The study, planned for initiation in first half of 2026 pending IRB approval and FDA IND clearance, will enroll five adult kidney transplant recipients at MGH. TNX‑1500 dosing is monthly for 12 months with induction including anti‑thymocyte globulin, tacrolimus and corticosteroids; tacrolimus is tapered with intent to discontinue by 12 months. The primary endpoint is adverse and serious adverse events at 12 months; secondary endpoints include graft survival, renal function, biopsy‑proven acute rejection and donor‑specific antibodies.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman, M.D. will present at BIO-Europe 2025 on November 4, 2025 at 3:00 p.m. CET in Presenting Company Theater 1 at the Vienna Congress and Convention Center.
The presentation will overview Tonix’s strategy and pipeline, highlighting near-term clinical, regulatory, and commercial milestones. The company markets approved products including Tonmya for fibromyalgia and two acute migraine treatments, and it disclosed a DTRA contract for up to $34 million for TNX-4200. Management meetings can be requested via the BIO One-on-One Partnering system.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 RESILIENT data showing statistically significant pain reduction (p<0.0001) with Tonmya (cyclobenzaprine HCl sublingual tablets) versus placebo in adults with fibromyalgia.
The 14-week, randomized, double-blind trial enrolled 456 intent-to-treat participants across 34 U.S. sites. Tonmya also produced meaningful improvements in sleep, fatigue, and fibromyalgia symptoms/function, and exploratory analyses showed sexual function gains in female participants.
Tonmya was FDA approved on August 15, 2025. Safety findings included low adverse event–related discontinuations (6.1% on Tonmya vs 3.5% placebo) and mostly mild oral mucosal reactions; labeled risks include embryofetal toxicity and serotonin syndrome drug interactions.