Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Presented an Analysis of Phase 3 Data Demonstrating TONMYA® Improved Physical Symptoms and Functional Ability of Patients with Fibromyalgia at the IASP 2026 World Congress on Pain

Tonix presented a combined analysis of the Phase 3 RELIEF and RESILIENT studies at the IASP 2026 World Congress on Pain showing TONMYA improved FIQR Symptoms and Function scores versus placebo in fibromyalgia patients. Both domains reached statistical significance at Week 14 in RESILIENT (p≤0.001) and nominal significance in RELIEF (p<0.01), with no new safety signals observed. TONMYA was FDA-approved in August 2025 and commercially launched in November 2025 as the first new fibromyalgia treatment in over 15 years; the data support its positioning as a first-line, non-opioid option.

•5d ago

Tonix Pharmaceuticals Announces Second Major Managed Medicare Payer Agreement for TONMYA®

Tonix Pharmaceuticals signed a second major managed Medicare agreement for TONMYA, its newly approved fibromyalgia treatment, effective immediately and adding approximately 21 million Medicare lives. With the new deal, Medicare coverage totals 32 million lives, and combined commercial and government payer coverage reaches approximately 166 million covered lives, about 53% of the roughly 314 million total U.S. population. Chief Commercial Officer Thomas Englese said approximately 50 new sales representatives have been fully activated, bringing the total sales force to 150, as the company works to convert expanded coverage into patient access for the drug the FDA approved on August 15, 2025.

•1mo ago

Tonix Pharmaceuticals Promotes Thomas Englese, MBA, to Chief Commercial Officer

Tonix Pharmaceuticals promoted Thomas Englese, MBA, to Chief Commercial Officer, effective immediately, the first time the company has filled that role. Englese has served as Executive Vice President, Commercial Operations, since September 2024. He continues to direct sales, marketing, market access, and commercial operations for TONMYA in fibromyalgia and the acute migraine products Zembrace SymTouch and Tosymra. CEO Seth Lederman called the promotion an important milestone, crediting Englese with building the commercial organization and launching TONMYA, which the company describes as a first-in-class, non-opioid analgesic and the first new fibromyalgia treatment in more than 15 years. Englese cited an encouraging launch start, access wins, and improving launch key performance indicators, with priorities focused on expanding access, growing patients and prescribers, and increasing sales.

•1mo ago

Tonix Pharmaceuticals Reports Second Quarter 2026 Financial Results and Operational Highlights

Tonix reported Q2 2026 net product revenue of $13.5 million, driven primarily by TONMYA net sales of $11 million, which increased 197% quarter-over-quarter following the product's commercial launch. Commercial execution advanced with payer coverage expanding to approximately 136 million lives (43% of U.S. total) and total prescriptions growing 100% quarter-over-quarter to 12,592. Pipeline progress included the first patient enrollment in the Phase 2 HORIZON study for TNX-102 SL, while the company maintained a strong balance sheet with $176.2 million in cash to fund operations into early Q2 2027.

•2mo ago

Tonix Pharmaceuticals Announces Positive Minutes from Type C FDA Meeting to Discuss Adaptive Phase 2 Field Study of TNX-4800, a Human, anti-OspA Monoclonal Antibody, to Prevent Lyme Disease in the U.S.

Tonix Pharmaceuticals announced alignment with the FDA on the design of an adaptive Phase 2 field study for TNX-4800, a long-acting monoclonal antibody intended to prevent Lyme disease. The randomized, placebo-controlled study plans to enroll approximately 3,300 adults over two seasons, with participants receiving two 450 mg subcutaneous doses three months apart. Manufacturing of the investigational product remains on track for delivery to study sites in the first quarter of 2027.

•2mo ago

Tonix Pharmaceuticals Announces Publication in the Peer-Reviewed Journal of Virology Assessing Virulence of the 2022 Outbreak Strain of Mpox in New Animal Models

Tonix Pharmaceuticals announced the publication of research in the Journal of Virology demonstrating that the 2022 mpox outbreak strain (clade IIb) is significantly less virulent than the historic 2003 strain (clade IIa). The study identified three new murine models for investigating mpox pathogenesis, which will support the continued development of the company’s vaccine candidate, TNX-801. TNX-801 is a live, attenuated horsepox virus vaccine currently in pre-IND stages, with a Phase 1 study expected to commence in 2027 pending FDA clearance.

•3mo ago

Tonix Pharmaceuticals Announces Major Managed Medicare Payer Agreement for TONMYA®

Tonix Pharmaceuticals secured a major managed Medicare agreement for TONMYA, adding approximately 9 million Medicare lives effective January 1, 2027. Combined with prior commercial agreements and Medicaid access, the deal expands total pharmacy coverage to roughly 145 million lives, representing 46% of all covered lives in the U.S. To capitalize on the expanded access, the company is deploying 50 new sales representatives by mid-third quarter 2026, increasing the total sales force to approximately 150 personnel.

•3mo ago

Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)

Tonix Pharmaceuticals enrolled the first patient in the HORIZON Phase 2 study, evaluating TNX-102 SL as a first-line monotherapy for Major Depressive Disorder (MDD). The potentially pivotal study aims to enroll approximately 360 patients across 30 U.S. sites over 6 weeks, with the primary endpoint measuring change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. TNX-102 SL is already commercially approved as TONMYA for fibromyalgia, and the company is leveraging its safety profile to address the high unmet need in the MDD market.

•4mo ago

Tonix Pharmaceuticals Secures Second Commercial Payer Agreement for TONMYA®, Expanding Total Commercial Coverage to ~52 Million U.S. Lives

Tonix Pharmaceuticals secured a second commercial payer agreement with a leading group purchasing organization (GPO), effective June 1, 2026. This agreement adds approximately 17 million U.S. commercial lives to TONMYA’s coverage, bringing total commercial coverage to ~52 million lives, or 29% of the U.S. commercial market. The company also noted that TONMYA is now available in most states under Medicaid, covering approximately 75 million lives, with Medicare discussions continuing.

•4mo ago

Tonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis of Opioid Use in Patients with Fibromyalgia at the 2026 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Tonix Pharmaceuticals presented retrospective real-world claims data at the 2026 ASCP Annual Meeting, highlighting that over 40% of fibromyalgia patients in the U.S. are prescribed opioids despite clinical guidelines discouraging their use. The study, based on 261,776 patients from Symphony Health data, underscores the persistent health burden of opioid reliance and the gap in prescriber education regarding non-opioid alternatives. This presentation supports the commercial launch of TONMYA, Tonix’s first-in-class, FDA-approved non-opioid treatment for fibromyalgia, which launched in November 2025.

•5mo ago

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

Tonix Pharmaceuticals published Phase 1 clinical data for TNX-1500, an Fc-modified anti-CD40L monoclonal antibody, in the Journal of Clinical Immunology. The study of 26 healthy volunteers showed TNX-1500 was well tolerated with no serious adverse events and demonstrated dose-proportional pharmacokinetics with half-lives supporting monthly dosing. TNX-1500 successfully blocked primary and secondary T cell-dependent antibody responses, validating its mechanism of action for preventing transplant rejection. An investigator-initiated Phase 2 study at Massachusetts General Hospital is expected to begin in the second half of 2026 pending FDA IND clearance.

•5mo ago

Tonix Pharmaceuticals Reports First Quarter 2026 Financial Results and Operational Highlights

Tonix Pharmaceuticals reported first quarter 2026 net product revenue of $6.9 million, a significant increase from $2.4 million in the same period in 2025. The revenue growth is primarily driven by the commercial launch of TONMYA, which generated $3.7 million in net sales. The company signed a managed care partnership with a leading group purchasing organization (GPO) in May, providing access to TONMYA for approximately 35 million U.S. commercial lives. Tonix plans to initiate an adaptive Phase 2 field study for TNX-4800, a long-acting human monoclonal antibody for Lyme disease prevention, in the first half of 2027, pending FDA agreement. Tonix also announced the dosing of the first participant in a Phase 1 study of TNX-1900, a broad-spectrum antiviral, at Erasmus University in March 2026.

•5mo ago

Tonix Pharmaceuticals Secures Commercial Payer Coverage for TONMYA®, Providing Access for ~35 Million U.S. Patients

Tonix Pharmaceuticals announced an agreement with a leading group purchasing organization effective May 1, providing coverage for TONMYA to approximately 35 million U.S. commercial lives. This represents roughly 20% of the estimated 177 million commercial lives in the U.S. and marks the first managed care partnership for TONMYA, a first-in-class non-opioid treatment for fibromyalgia. Additionally, TONMYA is currently covered under Medicaid in 38 states for approximately 55 million lives, representing 73% of the roughly 75 million Medicaid lives.

•5mo ago

Tonix Pharmaceuticals Announces Presentation of Phase 1 Data and Plans for an Adaptive Phase 2 Field Study of TNX-4800 (anti-Borrelia OspA monoclonal antibody) for the Prevention of Lyme Disease at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University

Tonix Pharmaceuticals presented positive Phase 1 data for TNX-4800, a long-acting monoclonal antibody designed to prevent Lyme disease, and outlined plans for an adaptive Phase 2 field study to begin in the first half of 2027. The planned Phase 2 study will test a two-dose subcutaneous regimen with the primary endpoint of preventing Lyme disease for six months following the initial dose. The company has scheduled a Type C meeting with the FDA in early Q3 2026 to discuss the study design, with GMP investigational product expected to be available in early 2027.

•6mo ago

Tonix Pharmaceuticals Presents Updates on Preclinical Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting 2026

Tonix Pharmaceuticals presented preclinical data for its immuno-oncology candidates TNX-1700 and TNX-4700 at the AACR Annual Meeting. TNX-1700 reversed aging-associated gastric inflammation and attenuated tumor progression in preclinical models, showing linear pharmacokinetics. TNX-4700 demonstrated potent, high-affinity binding and functional antagonism of BTLA in vitro.

•6mo ago