Accessibility StatementSkip Navigation NORTH CHICAGO, Ill., Dec. 1, 2025 /PRNewswire/ --Â AbbVie (NYSE: ABBV) today announced primary results from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of atogepant (60 mg) versus placebo for the acute treatment of migraine in adults (with or without aura). The study met its primary and key secondary endpoints, with atogepant demonstrating superiority in pain freedom and freedom from most bothersome migraine symptom (MBS) two hou ...

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 Viewpoint - Amneal Pharmaceuticals has launched Brekiya®, the first and only ready-to-use dihydroergotamine autoinjector for the acute treatment of migraines and cluster headaches in adults, available exclusively through Walgreens and Sterling Specialty Pharmacy [1][2]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, focusing on the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, particularly in the U.S. market [20]. Product Information - Brekiya is indicated for the acute treatment of migraine with or without aura and acute cluster headaches in adults, but it is not intended for the prevention of migraines or treatment of other headache types [5]. - The autoinjector allows patients to self-administer treatment conveniently, potentially reducing emergency room visits [2]. Market Context - Approximately 43 million Americans suffer from migraines, and around 300,000 live with cluster headaches, highlighting a significant market need for effective treatment options [3]. - Headache disorders are the fourth most common reason for emergency department visits in the U.S., accounting for nearly 3% of cases [3]. Pricing and Accessibility - Eligible commercially insured patients may pay as little as $40 per carton, which contains four single-dose autoinjectors, with support from field reimbursement specialists for patient access and coverage questions [8]. Safety Information - Brekiya should not be taken with strong CYP3A4 inhibitors due to the risk of serious interactions that can lead to life-threatening reductions in blood flow [4][6]. - The product is contraindicated for individuals with certain medical conditions, including heart problems, uncontrolled high blood pressure, and peripheral vascular disease [9].

Core Insights - H. Lundbeck A/S is showcasing its leadership in migraine management with new data on eptinezumab at the 2025 International Headache Congress, emphasizing the drug's long-term effectiveness and safety in chronic migraine patients [1][2][3] Group 1: Clinical Trials and Results - The RESOLUTION trial demonstrated that approximately 50% of patients achieved a ≥50% reduction in monthly migraine days (MMDs) after 12 weeks of treatment with eptinezumab, with a baseline of 20.9 MMDs [1][9][10] - The SUNSET trial, an extension of the SUNRISE trial, showed that 35.7% of Japanese patients achieved a ≥50% reduction in MMDs by weeks 49-60, with a trend towards increased response rates over the 60-week period [1][12][13] - Eptinezumab was well tolerated in both trials, aligning with previous studies on migraine prevention [1][2] Group 2: Presentations at the International Headache Congress - Lundbeck will present six studies at the 2025 International Headache Congress, including three oral presentations on eptinezumab and Lu AG09222 [2][4] - Key presentations include the efficacy and safety of eptinezumab in chronic migraine and medication-overuse headache, as well as patient-reported outcomes in a predominantly Asian population [4][5] Group 3: Migraine Impact and Management - Migraine is a leading cause of years lived with disability, affecting nearly 50 million people in Europe and costing the economy EUR 18 billion annually [6][10] - The chronic nature of migraine and associated medication overuse headache can lead to increased disability and a cycle of worsening symptoms without proper management [7][8]

Core Insights - Axsome Therapeutics, Inc. is presenting data from the SYMBRAVO clinical program at the 67th Annual Scientific Meeting of the American Headache Society, highlighting its advancements in treating central nervous system disorders [1] Group 1: SYMBRAVO Clinical Data - The SYMBRAVO program includes multiple presentations, such as the efficacy of SYMBRAVO based on migraine-associated disability from the INTERCEPT trial [1] - Long-term effects of SYMBRAVO on headache burden and quality of life will be discussed, showcasing results from the MOVEMENT trial [1] - Topline results from the EMERGE trial will focus on the efficacy and safety of SYMBRAVO in patients with inadequate response to oral CGRP inhibitors [1] Group 2: Product Information - SYMBRAVO is a novel oral medication combining meloxicam and rizatriptan, approved for acute migraine treatment in adults [2] - The formulation utilizes MoSEIC technology for rapid absorption and prolonged plasma half-life, aiming for effective migraine pain relief [2] - SYMBRAVO is not intended for migraine prevention or treatment of specific types of migraines such as hemiplegic or basilar migraines [4] Group 3: Company Overview - Axsome Therapeutics focuses on innovative treatments for central nervous system conditions, with a portfolio that includes FDA-approved therapies for major depressive disorder and narcolepsy [30] - The company aims to address significant gaps in care through differentiated products and novel mechanisms of action [30] - Axsome's mission is to improve patient outcomes for neurological and psychiatric conditions affecting over 150 million people in the U.S. [30]

Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on treating central nervous system (CNS) disorders, with a mission to address significant gaps in care and improve patient outcomes through innovative products [3] - The company has an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, along with multiple late-stage development programs targeting serious neurological and psychiatric conditions affecting over 150 million people in the U.S. [3] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide, highlighting the critical need for effective treatment options [2] - The Association of Migraine Disorders emphasizes the importance of funding and advancing migraine research, as well as educating patients and healthcare providers about the condition [2] Community Engagement - In recognition of Migraine and Headache Awareness Month, Axsome is supporting various Miles for Migraine Run, Walk or Relax events across the U.S. and providing resources for patients and their families affected by migraine [1][3] - The company collaborates with leading migraine advocacy organizations to share educational resources and support for individuals impacted by migraine [3][5]

Core Insights - Axsome Therapeutics has launched SYMBRAVO, a novel treatment for acute migraine, which combines meloxicam and rizatriptan, targeting multiple pathways involved in migraine attacks [1][4][30] - SYMBRAVO provides rapid pain relief within 2 hours and can sustain pain freedom for up to 24 hours in some patients after a single dose [1][4] - The treatment addresses a significant unmet need, as 63% of migraine patients reported dissatisfaction with their current treatment options [2][30] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for various conditions [30] - The company utilizes its patented MoSEIC™ technology to enhance the absorption and effectiveness of its migraine treatment [4][30] - Axsome is committed to improving patient outcomes through comprehensive support services, including the SYMBRAVO On My Side program, which offers financial assistance and educational resources [3][30] Industry Context - Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide [2][30] - The introduction of SYMBRAVO is expected to provide a valuable new option for patients who have not found relief with existing treatments [2][30] - The National Headache Foundation emphasizes the importance of new FDA-approved options to address the needs of the migraine community [2]

Core Viewpoint - Amneal Pharmaceuticals has received FDA approval for Brekiya, the first and only dihydroergotamine autoinjector for the acute treatment of migraines and cluster headaches in adults [1][4]. Product Overview - Brekiya autoinjector offers sustained pain relief in a self-administered format, containing the same medication used in hospitals [2][3]. - The device is easy to use, requiring no refrigeration or assembly, and allows for subcutaneous injection into the thigh [2][3]. - It is designed for patients who may not respond well to oral medications or have conditions that delay treatment [2][4]. Market Context - Approximately 39 million Americans suffer from migraines, with around one million experiencing cluster headaches [4]. - Headaches are a leading cause of emergency room visits, accounting for 3% of all visits in the U.S. [4]. - Brekiya addresses a significant gap in treatment options for cluster headaches, which are often underserved [4]. Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company focused on developing a diverse portfolio of over 280 pharmaceuticals, including injectables and biosimilars [22]. - The company aims to expand its presence in complex product categories and therapeutic areas, particularly in central nervous system and endocrine disorders [22].