BERKELEY HEIGHTS, N.J., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully integrated, commercial biotechnology company, announced today that Tonix management will present and host investor meetings at the following January 2026 investor conferences. Sachs Associates 9th Annual Neuroscience Innovation Forum Company Presentation Presenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals Date: Sunday, January ...

Core Insights - Tonix Pharmaceuticals is developing TNX-4800, a long-acting human monoclonal antibody targeting Borrelia burgdorferi, the causative agent of Lyme disease, with plans for clinical trials to begin in early 2027 [1][2][3] Group 1: Product Development - TNX-4800 is designed for annual seasonal use, administered subcutaneously in the spring to provide protection against Lyme disease throughout the tick season [1][3] - The company plans to meet with the FDA in 2026 to discuss Phase 2/3 development options, including a controlled human infection model (CHIM) study [2] - TNX-4800 has shown 95% effectiveness in preventing infection in non-human primates after exposure to infected ticks [3] Group 2: Market Potential - Approximately 70 million people in the U.S. living in Lyme disease-endemic areas could benefit from TNX-4800 as a pre-exposure prophylactic [1] - There are currently no FDA-approved vaccines or prophylactics available for Lyme disease in the U.S., highlighting a significant market opportunity for TNX-4800 [1][2] Group 3: Safety and Efficacy - TNX-4800 demonstrated rapid systemic absorption, with serum concentrations remaining quantifiable for over 200 days in 80% of volunteers at the lowest dose [4][5] - The mean half-life of TNX-4800 ranged from 62 to 69 days across different dosage groups, indicating prolonged efficacy [4] - Most adverse events reported were mild or moderate, and TNX-4800 was generally well tolerated [5] Group 4: Lyme Disease Overview - Lyme disease is the most common vector-borne infection in the U.S., with increasing incidence, particularly in the Northeast, mid-Atlantic, and upper-Midwest regions [6] - Typical symptoms include fever, headache, fatigue, and a characteristic skin rash, with untreated cases potentially leading to severe complications [6]

Non-opioid analgesic shows efficacy in several animal pain models, including diabetic and chemotherapy-induced neuropathic pain Compelling safety and pharmacokinetic profiles in animals support IND-enabling studies CHATHAM, N.J., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced licensing exclusive worldwide rights to TNX-4900 (formerly known as PW507), a highly selective small ...

Core Insights - Tonix Pharmaceuticals has received FDA clearance for the IND application of TNX-102 SL, a sublingual tablet formulation for treating major depressive disorder (MDD) in adults, with plans to initiate a pivotal Phase 2 HORIZON study in mid-2026 [1][2][4] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with a focus on central nervous system disorders, immunology, and infectious diseases, and markets FDA-approved products including TONMYA for fibromyalgia [7][8] - The company is developing TNX-102 SL not only for MDD but also for other indications such as Long COVID, PTSD, and agitation in Alzheimer's disease [5][7] Clinical Development - The Phase 2 HORIZON study will be a 6-week, randomized, double-blind, placebo-controlled trial involving approximately 360 patients across 30 U.S. sites, targeting adults aged 18 and older experiencing moderate to severe MDD [2][4] - The primary endpoint of the study is the change in MADRS total score from baseline at Week 6, with secondary endpoints including global impression scores and measures of sleep disturbance [2][4] Mechanism of Action - TNX-102 SL is designed to address disturbed sleep associated with depression, utilizing a novel mechanism of action that differentiates it from traditional antidepressants [3][5] - The formulation allows for rapid absorption and minimizes the production of the active metabolite, potentially reducing side effects commonly associated with traditional antidepressants [5][6] Market Need - Over 21 million adults in the U.S. experience a major depressive episode annually, highlighting the urgent need for effective and well-tolerated treatment options [4][5] - Many existing antidepressants are not adequately effective for all patients, and side effects often lead to discontinuation of treatment, underscoring the demand for innovative therapies [4][5]

Summary of Tonix Pharmaceuticals Holding (TNXP) Conference Call - August 18, 2025 Company Overview - **Company**: Tonix Pharmaceuticals Holding Corp (TNXP) - **Product**: Tonmya (sublingual cyclobenzaprine HCL tablets) - **Indication**: Treatment of fibromyalgia - **FDA Approval Date**: August 15, 2025 Key Points Industry Context - **Fibromyalgia**: A common chronic pain condition affecting over 10 million adults in the U.S. [12][33] - **Market Need**: Significant unmet medical need with only 2.7 million diagnosed and treated annually, while 75% of patients remain undiagnosed [33][34] - **Current Treatment Landscape**: High dissatisfaction with existing therapies, with first-line treatments failing in 85% of patients [34] Product Highlights - **Tonmya**: First new FDA-approved medication for fibromyalgia in over 15 years, designed for long-term treatment [15][49] - **Mechanism of Action**: Non-opioid analgesic that bypasses first-pass liver metabolism, leading to effective pain relief [18][19] - **Clinical Trials**: Two pivotal phase three trials with nearly 1,000 patients demonstrated significant pain reduction compared to placebo [24][25] - **Trial Results**: - Trial 1: 1.9 reduction in pain for Tonmya vs. 1.5 for placebo (p=0.01) - Trial 3: 1.8 reduction for Tonmya vs. 1.2 for placebo (p<0.001) [25] Financial Position - **Cash Reserves**: Approximately $125 million at the end of Q2 2025, with an additional $50 million raised in Q3 2025 [16] - **Debt Status**: No debt, providing a runway into 2026 for the product launch [16] Launch Strategy - **Commercial Readiness**: Experienced leadership team in place, with 90 sales representatives (10 internal, 80 contract) prepared for launch [55][32] - **Targeting High Prescribers**: Focus on the 5% of healthcare providers responsible for 70% of fibromyalgia prescriptions [40][43] - **Omnichannel Engagement**: Combining in-person promotion with digital outreach to educate both patients and healthcare providers [44][46] Market Dynamics - **Patient Engagement**: Early disease awareness campaign "Move Fibro Forward" attracted 36,000 unique visitors in the first three weeks [38][39] - **Opioid Crisis Context**: Tonmya aims to provide a non-addictive alternative to off-label opioid prescriptions commonly used for fibromyalgia [37][38] Intellectual Property - **Patent Portfolio**: Strong intellectual property with issued patents covering the unique formulation of Tonmya, providing exclusivity until at least 2034 [96] Future Outlook - **Sales Projections**: Conservative estimates for initial sales in 2025, with expectations for growth in 2026 as awareness and access improve [98] - **Research Plans**: Ongoing studies to explore the long-term impact of Tonmya and its role in earlier treatment of fibromyalgia [80] Conclusion - **Significance of Approval**: The approval of Tonmya represents a major advancement for fibromyalgia treatment, addressing a long-standing unmet need in the market [50][49] - **Commitment to Patients**: The company emphasizes its dedication to improving the lives of those suffering from fibromyalgia and plans to maintain open communication with stakeholders [104]