Core Insights - Tonix Pharmaceuticals Holding Corp. announced a poster presentation for Tonmya™ (cyclobenzaprine HCl sublingual tablets) at the 2025 American College of Rheumatology Convergence, highlighting its efficacy in pain reduction and tolerability for fibromyalgia patients [1][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 [3]. - The company has received FDA approval for Tonmya™, marking the first new prescription medicine for fibromyalgia in over 15 years [3]. - Tonix also markets two treatments for acute migraine in adults and is developing TNX-102 SL for acute stress reaction, major depressive disorder, and other conditions [3]. Product Development - Tonmya™ is indicated for the treatment of fibromyalgia in adults and is a first-in-class, non-opioid analgesic [3][7]. - The company is developing TNX-1500, an Fc-modified humanized monoclonal antibody for organ transplant rejection and autoimmune diseases [3]. - Tonix's infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4800, a monoclonal antibody for Lyme Disease prevention [3]. Clinical Presentation - The poster presentation titled "TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia" will take place on October 27, 2025, in Chicago, Illinois [3].

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]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges [4] - The company operates a state-of-the-art infectious disease research facility in Frederick, MD, and its development portfolio includes central nervous system disorders, immunology, and infectious diseases [4] Campaign Launch - Tonix Medicines, Inc., a commercial subsidiary of Tonix Pharmaceuticals, launched the "Move Fibro Forward" campaign to raise awareness and support for individuals affected by fibromyalgia [1][2] - The campaign aims to validate the experiences of those suffering from fibromyalgia and encourage them to seek education and resources [2] Fibromyalgia Insights - Fibromyalgia is a chronic pain disorder affecting an estimated 10 million adults in the U.S., with approximately 90% being women [3] - Common symptoms include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction, leading to impaired quality of life and frequent disability [3]

Core Insights - TNX-102 SL is a sublingual formulation of cyclobenzaprine aimed at treating fibromyalgia, with an FDA PDUFA goal date of August 15, 2025, potentially becoming the first new non-opioid analgesic for fibromyalgia in over 15 years [1][7] - The drug has shown statistically significant improvement in reducing fibromyalgia pain in two Phase 3 studies, demonstrating durable activity over 14 weeks [2][3] - TNX-102 SL targets sleep disturbances associated with fibromyalgia and has a favorable tolerability profile, acting as a potent antagonist at four post-synaptic receptors [3][6] Company Overview - Tonix Pharmaceuticals is a biotechnology company focused on developing therapies for pain management and CNS disorders, with TNX-102 SL as a priority product candidate for fibromyalgia [7] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on positive Phase 3 study results and has received Fast Track designation from the FDA [7] - Tonix also has a diverse development portfolio, including treatments for acute stress reactions, organ transplant rejection, and infectious diseases [7] Industry Context - Fibromyalgia affects over 10 million adults in the U.S., primarily women, and is characterized by chronic pain, non-restorative sleep, and cognitive dysfunction [4] - Current treatment options are often unsatisfactory, leading many patients to rely on chronic opioids, which carry risks of addiction and overdose [2][4] - TNX-102 SL's unique formulation aims to provide a new therapeutic option that addresses both pain and sleep disturbances without the risks associated with opioids [2][6]