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Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Compan ...

Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND TNX-2900 granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, providing the potential for a Priority Review Voucher upon approval Magnesium-potentiated intranasal oxytocin formulation designed to reduce dose-related inconsistencies in receptor activity CHATHAM, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Toni ...

Core Insights - Tonix Pharmaceuticals is advancing TNX-102 SL, a potential first-in-class treatment for major depressive disorder (MDD), with an IND application expected in Q4 2025 [1][3] - TNX-102 SL is already FDA-approved for fibromyalgia and is being explored for its effects on sleep quality and depressive symptoms [1][2] Company Overview - Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [5] - The company recently received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [6] - Tonix's development portfolio focuses on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [6] Product Development - TNX-102 SL is a patented sublingual formulation designed for rapid absorption, bypassing first-pass metabolism, and is currently approved for fibromyalgia [4] - The drug is also being developed for other indications, including acute stress reaction, PTSD, and Long COVID [4] - The FDA provided positive feedback during the Pre-IND meeting, indicating a reasonable long-term safety data collection plan [2][3] Clinical Data - In the Phase 3 RESILIENT study, TNX-102 SL showed significant improvement in depressive symptoms among fibromyalgia patients compared to placebo, with a p-value of less than 0.05 [3] - The biological relationship between depressive symptoms in fibromyalgia and MDD remains unclear [3] Intellectual Property - Tonix holds multiple patents related to TNX-102 SL, providing market exclusivity until at least 2034, with potential extensions until 2044 for method of use [4]

Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1) Planning adaptive Phase 2/3 study Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company with marketed products and a pipeline of developme ...

Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia Tonmya is expe ...

Summary of Tonix Pharmaceuticals Holding (TNXP) Conference Call Company Overview - **Company Name**: Tonix Pharmaceuticals Holding Corp - **Ticker Symbol**: TNXP - **Recent Approval**: FDA approval for Onmya (cyclobenzaprine sublingual tablets) for treating fibromyalgia in adults on August 15, 2025 [2][4] - **Current Focus**: Launching Onmya and leveraging existing commercial infrastructure from previously marketed migraine drugs [2][3] Industry Insights - **Fibromyalgia Prevalence**: Approximately 10 million American adults are affected by fibromyalgia, with about 3 million diagnosed and treated [4][10] - **Diagnosis Challenges**: On average, it takes about six years for patients to receive a fibromyalgia diagnosis, highlighting a significant unmet need in timely treatment [10][18] - **Evolving Understanding**: Fibromyalgia is increasingly recognized as a nociplastic syndrome, with symptoms including widespread pain, fatigue, sleep disturbances, and cognitive issues [10][12] Onmya Product Insights - **Mechanism of Action**: Onmya is designed to target non-restorative sleep and pain, differentiating itself from existing therapies by bypassing hepatic metabolism and reducing the major metabolite, norcyclobenzaprine [22][23] - **Comparison with Other Therapies**: Onmya is positioned as a first-in-class drug targeting fibromyalgia, with a potentially broader spectrum of effects compared to existing treatments like Lyrica and Cymbalta [25][26] - **Tolerability Profile**: Onmya is not DEA scheduled, which may enhance its prescription potential compared to Lyrica, which has lower prescribing rates due to its scheduling [28][29] Commercial Strategy - **Target Market**: Initial launch targets the 3 million diagnosed patients, with plans to expand to the larger population of 10 million [32][34] - **Sales Force Strategy**: Tonix plans to hire additional sales representatives and utilize a combination of internal and contract sales forces to effectively reach healthcare providers [34][38] - **Pricing Strategy**: Pricing for Onmya has not yet been announced, but factors include health economics related to fibromyalgia treatment costs and the potential benefits of non-opioid therapies [39][40] Additional Considerations - **Opioid Use in Fibromyalgia**: There is a significant off-label use of opioids for fibromyalgia, which is concerning as long-term use may worsen the condition [29][30] - **Patient Advocacy**: Many patients may be aware of their fibromyalgia but have not sought diagnosis due to dissatisfaction with current treatment options [35][36] This summary encapsulates the key points discussed during the conference call, providing insights into Tonix Pharmaceuticals' strategic direction, product differentiation, and the broader context of fibromyalgia treatment.

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates [3] - The company recently received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and has a development portfolio focused on CNS disorders, immunology, immuno-oncology, and infectious diseases [3] Product Development - Tonmya™ is indicated for the treatment of fibromyalgia in adults [7] - The company is developing TNX-102 SL for acute stress reaction and acute stress disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio includes TNX-1500, a monoclonal antibody for preventing allograft rejection and treating autoimmune diseases [3] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. DoD [3] Upcoming Events - Seth Lederman, M.D., the CEO of Tonix, will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference on September 4, 2025 [1] - A webcast of the event will be available on the company's website, with a replay accessible for 90 days post-event [2]

Core Viewpoint - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) experienced a decline of approximately 20% on Monday despite receiving FDA approval for its fibromyalgia therapy, Tonmya, which had previously caused a surge in share prices [1]. Company Summary - Tonix Pharmaceuticals received FDA approval for its fibromyalgia therapy, Tonmya, on Friday [1]. - The approval initially led to a significant increase in share prices, but the stock fell by about 20% the following Monday [1].

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]