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]

Core Insights - Tonmya™ is set to launch in November 2025, marking the first new FDA-approved treatment for fibromyalgia in over 15 years [1][5] - Tonix Pharmaceuticals reported cash and cash equivalents of $190.1 million as of September 30, 2025, which is expected to fund operations into the first quarter of 2027 [1][8] - The company is focused on successfully launching Tonmya and advancing its pipeline, including TNX-4800 for Lyme disease prevention and TNX-1500 for kidney transplant rejection [2][14] Commercial Updates - Tonmya (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic for fibromyalgia treatment [3] - Tosymra (sumatriptan nasal spray) has received preferred exclusive placement on a payer formulary effective January 1, 2026, covering approximately 16 million lives [3] Pipeline Updates - TNX-102 SL is in development for major depressive disorder (MDD) [4] - TNX-1500 is under investigation for kidney transplant rejection prevention and may also treat autoimmune disorders [4] - TNX-4800 is a long-acting monoclonal antibody in development for Lyme disease prevention, with plans for a Phase 2/3 study in 2027 [14] Financial Performance - For Q3 2025, net product revenue was approximately $3.3 million, an increase from $2.8 million in Q3 2024 [9] - Research and development expenses for Q3 2025 were $9.3 million, slightly up from $9.1 million in the same period in 2024 [10] - Selling, general, and administrative expenses surged to $25.7 million in Q3 2025, compared to $7.7 million in Q3 2024, primarily due to Tonmya-related marketing [11] - The net loss for Q3 2025 was $32.0 million, or $3.59 per share, compared to a net loss of $14.2 million, or $22.68 per share, in Q3 2024 [12] Balance Sheet Highlights - As of September 30, 2025, total assets were $252.4 million, with total liabilities at $21.3 million [21] - The company’s stockholders' equity increased to $231.1 million from $139.6 million as of December 31, 2024 [21]

Core Insights - Tonmya demonstrated significant reduction in fibromyalgia pain compared to placebo in the Phase 3 RESILIENT study, indicating its potential as a well-tolerated, non-opioid analgesic for adults with fibromyalgia [1][2] - The treatment was well tolerated with a discontinuation rate of 19% versus 20.8% for placebo, and minimal effects on weight or blood pressure [1][2] 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 [4] - The company received FDA approval for Tonmya on August 15, 2025, marking the first new prescription medicine approval for fibromyalgia in over 15 years [3][4] - Tonix also markets treatments for acute migraine and is developing TNX-102 SL for acute stress reaction and major depressive disorder [4] Clinical Study Details - The RESILIENT study was a 14-week randomized, double-blind, placebo-controlled trial involving 456 participants across 34 U.S. sites, meeting the 2016 American College of Rheumatology criteria for fibromyalgia [2] - Statistically significant reductions in weekly average pain scores were observed at Week 14 (p<0.0001) compared to placebo, along with improvements in sleep quality, fatigue, and other fibromyalgia symptoms [2] Treatment Profile - Tonmya's favorable tolerability profile includes minimal impact on weight and blood pressure, no adverse sexual side effects, and a low rate of adverse event-related discontinuations [2][3] - The most common adverse events were mild oral cavity reactions, which rarely led to study withdrawal [2]

Tonmya Approval and Launch - TonmyaTM is the first FDA-approved medicine for fibromyalgia in over 15 years[1,13] - Tonix is well-positioned to support the commercial launch of TonmyaTM, expected in Q4 2025[13] - Tonix ended Q2 2025 with approximately $125 million in cash and cash equivalents and raised approximately $50 million in Q3 2025 through equity sales[41] - The company anticipates its cash runway will support the launch and other operations into Q3 2026[13,41] Clinical Efficacy and Safety - Clinical trials demonstrated durable reduction in fibromyalgia pain with TonmyaTM[22] - In Trial 1, the TONMYA group showed a change from baseline of -1.9 compared to -1.5 in the placebo group, with a p-value of 0.010[28] - In Trial 3, the TONMYA group showed a change from baseline of -1.8 compared to -1.2 in the placebo group, with a p-value of less than 0.001[29] - A greater percentage of study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo[35] - The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer[24,40,94] Market Opportunity and Commercial Strategy - Over 10 million people in the US are living with fibromyalgia[13,50] - Approximately 5% of fibromyalgia-diagnosing HCPs write approximately 70% of fibromyalgia prescriptions[62]

Core Insights - Tonmya is the first FDA-approved therapy for fibromyalgia in over 15 years, representing a significant advancement for the treatment of this chronic pain condition affecting over 10 million adults in the U.S. [1][2] - The approval of Tonmya was based on two pivotal Phase 3 clinical trials that demonstrated its efficacy in significantly reducing fibromyalgia pain compared to placebo [2][10] - Tonmya is expected to be commercially available in the fourth quarter of 2025 [1][6] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company focused on developing treatments for central nervous system disorders, immunology, immuno-oncology, and infectious diseases [12][13] - The company has a proprietary formulation for Tonmya, which is a sublingual tablet designed for rapid absorption and reduced production of long half-life metabolites [9] Industry Context - Fibromyalgia is a chronic pain disorder that affects an estimated 10 million adults in the U.S., with approximately 80% being women. It is characterized by chronic widespread pain, fatigue, and sleep disturbances [8] - The chronic pain associated with fibromyalgia significantly disrupts patients' daily lives and is often inadequately managed due to a lack of effective treatment options [4][8]

Core Insights - The RESILIENT trial data demonstrates that TNX-102 SL significantly reduces fibromyalgia pain compared to placebo, confirming previous findings from the RELIEF trial [1][2] - If approved, TNX-102 SL will be the first new drug for fibromyalgia in over 15 years, with a PDUFA target date set for August 15, 2025 [1][2] Company Overview - Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for pain management and central nervous system disorders [8] - The company has submitted a New Drug Application (NDA) for TNX-102 SL based on two statistically significant Phase 3 studies [2][8] Study Details - The RESILIENT study was a randomized, double-blind, placebo-controlled trial involving 457 adults with fibromyalgia across 33 sites in the U.S. [2][7] - Participants received TNX-102 SL in two dosage phases: 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, with a primary endpoint of pain reduction assessed over fourteen weeks [2][7] Efficacy Results - TNX-102 SL achieved a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale, compared to a 1.2-point reduction for placebo, indicating high statistical significance [2][7] - Statistically significant improvements were also noted across all six prespecified key secondary endpoints, including various patient-reported outcomes [2][3] Safety Profile - TNX-102 SL was generally well tolerated, with the most common adverse events being mild and transient, such as oral tingling/numbness and a bitter aftertaste [3] - No serious drug-related adverse events or deaths were reported, highlighting a favorable risk-benefit profile [3] Fibromyalgia Context - Fibromyalgia affects an estimated 6-12 million adults in the U.S., predominantly women, and is characterized by chronic pain, fatigue, and sleep disturbances [4] - Current treatment options are often met with dissatisfaction from both physicians and patients, indicating a significant unmet need in the market [4] Product Information - TNX-102 SL is a patented sublingual formulation of cyclobenzaprine hydrochloride designed for rapid absorption and reduced side effects [5][6] - The drug is also being explored for other indications, including acute stress reaction, Long COVID, and alcohol use disorder [5][8]

Core Viewpoint - Axsome Therapeutics has received a Refusal to File (RTF) letter from the FDA regarding its New Drug Application (NDA) for AXS-14 (esreboxetine) for fibromyalgia management, indicating that the submission was not sufficiently complete for substantive review [1][2] Company Summary - Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a portfolio that includes FDA-approved treatments for various conditions and ongoing late-stage development programs [7] - The company aims to address significant gaps in care by developing differentiated products with novel mechanisms of action [7] Product Summary - AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being investigated for fibromyalgia and other conditions, noted for its potency and selectivity compared to racemic reboxetine [5] - The drug is currently not approved by the FDA [5] Industry Context - Fibromyalgia is a chronic disorder affecting approximately 17 million Americans, predominantly women, characterized by widespread pain, fatigue, and other debilitating symptoms [6] - Current treatment options for fibromyalgia are limited, with only three pharmacologic treatments approved by the FDA [6] FDA Feedback and Next Steps - The FDA found one of the two placebo-controlled trials in the NDA submission inadequate due to its 8-week primary endpoint and flexible-dose design, while the other trial with a 12-week endpoint was deemed adequate [2] - In response, Axsome plans to conduct an additional controlled trial using a fixed-dose paradigm and a 12-week primary endpoint, expected to start in Q4 2025 [3][4]