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 (TNXP) reported third-quarter 2026 net product revenue of approximately $17.2 million, led by continued growth in TONMYA sales. Revenue compared with $3.3 million a year earlier. TONMYA sales were approximately $15 million, up 37% from the second quarter. Net loss widened to $53.3 million from $32.0 million, while loss per share narrowed to $2.89 from $3.59.
Cash totaled approximately $163 million at September 30, down from approximately $207.6 million at year-end. Tonix expects cash plus subsequent equity proceeds to fund operations and capital expenditures into early third-quarter 2027. TONMYA coverage reached approximately 166 million lives. Enrollment continues in the TNX-102 SL depression study. TNX-4800's Phase 2 study is expected to begin in first-quarter 2027, pending final FDA protocol agreement; a TNX-1500 kidney-transplant study is also expected to start that quarter.
Tonix Pharmaceuticals (Nasdaq: TNXP) management will present at Guggenheim’s 3rd Annual Healthcare Innovation Conference on November 10, 2026, in Boston.
President and Chief Executive Officer Seth Lederman will give the presentation from 4:00–4:25 p.m. ET. Management will also host one-on-one meetings. A live webcast and replay will be available in the Investors section of the Tonix website under News & Events.
Tonix Pharmaceuticals (TNXP) appointed George Lederman as Executive Vice President of Strategy and Transformation, effective October 30, 2026.
Lederman will lead artificial intelligence initiatives intended to improve operational efficiency and manage costs. He will also oversee business development, including evaluating potential partnerships and licensing opportunities to advance clinical programs. He previously served as Vice President of Global Strategy at Aliaxis and was an Associate Partner at McKinsey, where he advised clients on machine learning, analytics and artificial intelligence.
Lederman is the son of Seth Lederman, Tonix’s President, CEO and Chairman. Independent board and Audit Committee members approved the appointment under the company’s related-party transactions policy. Independent board and Compensation Committee members approved his compensation.
Tonix Pharmaceuticals (TNXP) presented Phase 3 analyses showing TONMYA improved physical symptoms and functional ability versus placebo in adults with fibromyalgia. The RELIEF and RESILIENT findings were presented at the IASP 2026 World Congress on Pain in Bangkok.
Both trials showed statistically and clinically significant improvements in the primary pain endpoint at Week 14. Scores on the Fibromyalgia Impact Questionnaire-Revised, which measures symptoms and daily functioning, improved more with TONMYA than placebo at Weeks 2, 6, 10 and 14. Week 14 results for both domains were statistically significant in RESILIENT (p≤0.001) but only nominally significant in RELIEF (p<0.01) because of the endpoint testing hierarchy.
No new safety signals were observed; the most common treatment-emergent adverse events were local oral administration site reactions. TONMYA was commercially launched in November 2025.
Tonix Pharmaceuticals (TNXP) will report third quarter 2026 financial results and operational highlights on November 9, 2026. The company will host a conference call and webcast at 8:30 a.m. ET. A replay will be available under “IR Events” in the Investors section of its website.
Tonix Pharmaceuticals (TNXP) will present a Phase 3 TONMYA data analysis at the IASP World Congress on Pain on October 27, 2026. The poster examines effects on fibromyalgia symptoms and physical function.
Errol Gould, Senior Vice President of Medical Affairs at Tonix Medicines, will present poster 157 during Session 2, from 3:15–4:45 p.m. ICT in Bangkok, Thailand. The poster will be available afterward on Tonix’s website under Scientific Presentations.
Tonix Pharmaceuticals (TNXP) announced a second major managed Medicare coverage agreement for TONMYA, its fibromyalgia treatment for adults, effective immediately and adding approximately 21 million Medicare lives, or 38% of about 55 million Medicare lives in the U.S.
This new agreement brings total TONMYA Medicare coverage to approximately 32 million lives, representing 58% of the U.S. Medicare population. Across commercial and government payers, TONMYA is now covered for about 166 million lives, or 53% of roughly 314 million total U.S. lives. The company previously secured commercial payer agreements with two group purchasing organizations and one major managed Medicare payer, and TONMYA is covered by Medicaid in nearly all states. Tonix reports that approximately 50 new sales representatives have been activated, increasing its sales force to 150 to support the product’s launch and capitalize on expanded access.
Tonix Pharmaceuticals (TNXP) has promoted Thomas Englese, MBA, to Chief Commercial Officer, effective immediately, elevating him from Executive Vice President, Commercial Operations, a role he has held since September 2024.
He will continue to lead sales, marketing, market access and commercial operations for TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults, and the acute migraine brands Zembrace SymTouch and Tosymra. The company credits his leadership with shaping its commercial organization and the U.S. launch and early growth of TONMYA across sales, managed care and patient access. Tonix describes TONMYA as the first treatment for fibromyalgia in more than 15 years and is extending its underlying science in Phase 2 studies for major depressive disorder and acute stress disorder/acute stress reaction, while also advancing Phase 2‑ready programs in infectious disease and immunology.
Tonix Pharmaceuticals (TNXP) will participate in Cantor’s 2026 Global Healthcare Conference in New York, where management will host a fireside chat and 1x1 meetings with investors.
The fireside chat, presented by President and CEO Seth Lederman, M.D., is scheduled for September 10, 2026, from 3:55–4:25 p.m. ET. A live webcast and replay will be accessible under the News & Events tab in the Investors section of the Tonix website. Tonix is a commercial-stage biopharmaceutical company focused on CNS disorders, infectious diseases, immunology, and rare diseases. Its marketed portfolio includes TONMYA for fibromyalgia and acute migraine products Zembrace SymTouch and Tosymra, alongside a pipeline of Phase 2 and vaccine candidates in multiple therapeutic areas.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported second quarter 2026 net product revenue of approximately $13.5 million, up from $2.0 million a year earlier, driven by about $11.0 million in TONMYA sales and $2.5 million from migraine products Zembrace SymTouch and Tosymra.
TONMYA prescriptions reached 12,592, doubling quarter-over-quarter, with new prescriptions up 36% and refills up 207%. Coverage expanded to roughly 136 million U.S. lives (43%), with an expected increase to 145 million (46%) in early 2027. Tonix plans to grow its TONMYA sales force to about 150 representatives by September 2026.
Cash and cash equivalents totaled approximately $176.2 million at June 30, 2026; net cash used in operating activities was $84.6 million for the first half of 2026. The company posted a Q2 2026 net loss to common stockholders of $40.6 million versus $28.3 million a year prior, and projects its cash will fund operations into early second quarter 2027. Tonix also reported progress across CNS, infectious disease, immunology, rare disease and immuno-oncology pipeline programs, including initiation of the Phase 2 HORIZON study in major depressive disorder and FDA-aligned plans for a Phase 2 Lyme disease prevention study of TNX-4800.