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 ...

Tonix Pharmaceuticals (TNXP) entered into a securities purchase agreement with Point72 for the purchase and sale of 615,025 shares of its common stock at an offering price of $16.26 per share and, in lieu of shares of common stock, pre-funded warrants to purchase up to an aggregate of 615,025 shares of common stock at a purchase price of $16.259 per pre-funded warrant, which equals the offering price per share of the common stock less the $0.001 per share exercise price of each pre-funded warrant. The clos ...

Group 1: Offering Details - Tonix Pharmaceuticals has entered into a securities purchase agreement with Point72 for the purchase of 615,025 shares of common stock at an offering price of $16.26 per share, along with pre-funded warrants to purchase an equal number of shares at a price of $16.259 per warrant [1] - The gross proceeds from the offering are expected to be approximately $20.0 million before deducting fees and expenses [2] - The closing of the offering is anticipated to occur on or about December 30, 2025, pending customary closing conditions [1][2] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund the commercialization of marketed products, the development of the product pipeline, and for general working capital and corporate purposes [2] Group 3: Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [5] - The company markets FDA-approved TONMYA™, a non-opioid analgesic for fibromyalgia, and two treatments for acute migraine: Zembrace® SymTouch® and Tosymra® [5] - Tonix's development portfolio includes investigational drugs for various conditions, including TNX-102 SL for acute stress reaction and major depressive disorder, and TNX-1500 for organ transplant rejection and autoimmune diseases [5][6]

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 appointed Irina Ishak as General Counsel, effective December 8, 2025, bringing over 25 years of experience in corporate legal and strategic leadership within the life sciences industry [1][2] - The company is focused on commercializing its marketed products and advancing its pipeline, with Ishak's expertise expected to be a significant asset in these efforts [2][3] Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a development pipeline [4] - The company markets TONMYA™, the first FDA-approved therapy for fibromyalgia in over 15 years, along with treatments for acute migraine [4] - Tonix's development portfolio targets central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4] Recent Developments - The company has recently launched TONMYA™, which is a non-opioid analgesic for fibromyalgia, and is expanding its research into other conditions [3][4] - Tonix is also developing TNX-102 SL for acute stress reaction and major depressive disorder, and has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent [4]

Group 1 - The article discusses Tonix Pharmaceuticals Holding Corp. (TNXP) and its potential to develop the first new fibromyalgia drug in 15 years [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and runs a service that provides in-depth analysis of pharmaceutical companies [2] - The Biotech Analysis Central service includes a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] Group 2 - The article does not provide any specific financial data or performance metrics related to Tonix Pharmaceuticals [1][3][4] - There are no disclosures regarding stock positions or plans to initiate positions in the companies mentioned [3] - The article emphasizes that past performance is not indicative of future results, and no investment recommendations are made [4]

Core Insights - The article discusses Tonix Pharmaceuticals Holding Corp. (TNXP) and its potential to develop the first new fibromyalgia drug in 15 years [2]. Company Overview - Tonix Pharmaceuticals is highlighted for its focus on the biotech sector, particularly in developing treatments for fibromyalgia [2]. - The company is part of a broader analysis service that provides insights into various pharmaceutical companies [1]. Analyst Background - The analysis is conducted by Terry Chrisomalis, who has extensive experience in the biotech sector and offers a library of over 600 articles related to biotech investing [2]. - The service includes a model portfolio of small and mid-cap stocks, live chat, and various analysis reports to assist healthcare investors [2].

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]

Core Insights - TONMYA is the first FDA-approved treatment for fibromyalgia in over 15 years, providing a novel non-opioid option for patients [1][4] - The drug is now available by prescription nationwide, targeting the estimated 10 million adults in the U.S. suffering from fibromyalgia [2][7] - The approval is based on positive results from two Phase 3 clinical trials, demonstrating significant pain reduction compared to placebo [5][9] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on central nervous system disorders, immunology, and rare diseases [11] - The company operates a state-of-the-art infectious disease research facility and markets treatments for fibromyalgia and acute migraine [11] Product Details - TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented formulation that allows for rapid absorption and is taken once daily at bedtime [8] - The drug targets neurotransmitters involved in fibromyalgia, marking a significant advancement in treatment options for patients [3][4] Clinical Trial Information - The Phase 3 trials, RELIEF and RESILIENT, involved nearly 1,000 patients and showed that TONMYA significantly reduced daily pain scores at 14 weeks [5][9] - A greater percentage of participants experienced a clinically meaningful improvement in pain after three months compared to those on placebo [5] Market Potential - The approval of TONMYA is expected to address the long-standing need for effective treatments in a patient population that has historically faced limited options [2][3] - The patents associated with TONMYA are expected to provide market exclusivity until 2034, with potential extensions until 2044 [8]