Core Insights - Tonix Pharmaceuticals has presented data showing that TONMYA significantly reduces fibromyalgia pain compared to placebo in a Phase 3 study, indicating its potential as an effective non-opioid treatment for this chronic pain disorder [1][2][3]. Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company that markets TONMYA™, the first new prescription medicine approved for fibromyalgia in over 15 years [4]. - The company also has a pipeline focused on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [5]. Product Details - TONMYA is a sublingual formulation designed for bedtime dosing, which bypasses first-pass metabolism, optimizing drug exposure during sleep and minimizing daytime exposure to its active metabolite [2][3]. - The Phase 3 RESILIENT trial involved 456 participants and demonstrated a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) with an effect size of 0.38, along with improvements in sleep disturbance, fatigue, and other fibromyalgia symptoms [2][3]. Market Need - Fibromyalgia affects over 10 million adults in the U.S., and there is a clear demand for effective non-opioid alternatives as current treatments often have tolerability issues and side effects [2][3].

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. is actively engaging with investors through presentations and meetings at various conferences in January 2026, showcasing its innovative pipeline and marketed products in the biotechnology sector [1][2][3]. Company Overview - Tonix Pharmaceuticals is a fully integrated biotechnology company with marketed products and a robust pipeline of development candidates [4]. - The company markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic for fibromyalgia, which is the first new prescription medicine approved for this condition in over 15 years [4]. - Tonix also offers treatments for acute migraine, including Zembrace® SymTouch® and Tosymra® [4]. Product Pipeline - Tonix's development portfolio focuses on central nervous system (CNS) disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [4]. - Key candidates include: - TNX-102 SL for acute stress reaction and major depressive disorder [4]. - TNX-1500, a Phase 2-ready monoclonal antibody for organ transplant rejection and autoimmune diseases [4]. - TNX-2900 for Prader-Willi syndrome, expected to start a pivotal Phase 2 study in 2026 [4]. - TNX-801, a vaccine for mpox and smallpox, and TNX-4800, a monoclonal antibody for Lyme disease prevention [4]. - TNX-4200, a broad-spectrum antiviral agent with a contract for up to $34 million from the U.S. Department of Defense [4]. Upcoming Conferences - Tonix's management will present at the Sachs Associates 9th Annual Neuroscience Innovation Forum on January 11, 2026, and at the Biotech Showcase 2026 on January 13, 2026 [2][3]. - The presentations will be led by Seth Lederman, M.D., the President and CEO of Tonix Pharmaceuticals [2][3]. Investor Relations - Investors interested in meetings with the company's management during the conferences can contact the provided email [4]. - Additional information about Tonix and its products can be found on the company's website [6].

Group 1 - Tonix Pharmaceuticals (TNXP) has 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 [1] - In addition to common stock, the agreement includes 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 [1] - The gross proceeds of the offering are expected to be approximately $20 million before deducting placement agent fees and other estimated offering expenses [1] Group 2 - The closing of the offering is anticipated to occur on or about December 30, subject to customary closing conditions [1] - TD Cowen is acting as the sole placement agent for the offering, while A.G.P./Alliance Global Partners is serving as a financial advisor [1]

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]

Core Insights - Tonix Pharmaceuticals has licensed exclusive worldwide rights to TNX-4900, a selective Sigma-1 receptor antagonist, which has shown analgesic activity in various neuropathic pain models [1][2] - The company aims to advance TNX-4900 through further pharmacokinetic, formulation, and safety studies to support IND-enabling development [4] 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 has additional treatments for acute migraine [5] Product Development - TNX-4900 was developed using computer-aided and AI-driven approaches, demonstrating robust analgesic efficacy and a favorable safety profile in preclinical models [2][4] - The compound binds to the human Sigma-1 receptor with a nanomolar affinity (Ki = 7.5 nM) and shows over 100-fold selectivity over the Sigma-2 receptor, with an oral bioavailability of approximately 28% [2] Research and Innovation - Foundational research into TNX-4900 represents a significant step towards developing non-opioid solutions for chronic pain, addressing the need for safer pain management options [3] - The compound has produced significant and durable reductions in pain behaviors in preclinical models without evidence of tolerance or motor impairment [4]

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]