For Hetlioz, full-year net product sales fell 7% to $71.4 million. Moran said the decline reflected lower volume and price net of deductions amid continued U.S. generic competition, while noting the brand “continued to retain the majority of market share despite generic competition now for over three years.” Ponvory net product sales were $27.4 million, down 2% versus 2024, with the company also noting that certain variable consideration tied to Ponvory sales remains subject to dispute.Total 2025 revenues a ...

Core Insights - MapLight Therapeutics, Inc. has updated the expected timing for topline results from its Phase 2 ZEPHYR and IRIS clinical studies, which are progressing ahead of schedule [1] Group 1: ZEPHYR Trial - The Phase 2 ZEPHYR trial is evaluating ML-007C-MA for treating schizophrenia and is expected to report topline results in Q3 2026 [2] - The ZEPHYR study is a randomized, double-blind, placebo-controlled trial enrolling approximately 300 hospitalized adult participants experiencing acute exacerbation of psychosis [2][3] - The accelerated enrollment pace in the ZEPHYR trial has allowed the company to narrow its timing guidance to Q3 2026, reflecting disciplined execution and commitment to quality [3] Group 2: IRIS Trial - The Phase 2 IRIS trial for ML-004 in autism spectrum disorder has completed enrollment, with topline results also expected in Q3 2026 [3] - The IRIS study is a double-blind, placebo-controlled trial that randomized around 160 adult and adolescent participants [3] Group 3: Company Overview - MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with central nervous system disorders [4] - The company was founded by leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies [4] - MapLight's discovery platform aims to identify neural circuits linked to diseases and target them for therapeutic modulation [4]

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].

Core Insights - Praxis Precision Medicines announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET) [1][2][19] - The studies demonstrated statistically significant improvements in key efficacy endpoints, indicating ulixacaltamide's potential as a treatment for ET [11][13] Study Results - In Study 1, patients treated with ulixacaltamide showed a mean improvement of 4.3 points in the Modified Activities of Daily Living (mADL11) at Week 8, with p<0.0001 [1][11] - All key secondary endpoints in Study 1 were statistically significant, including the rate of disease improvement and Patient Global Impression of change (PGI-C) [1][10] - Study 2 confirmed the maintenance of effect for ulixacaltamide, with 55% of patients maintaining response compared to 33% in the placebo group (p=0.0369) [13][14] Safety Profile - Ulixacaltamide was generally well tolerated, with no drug-related serious adverse events reported [1][16] - The most common treatment-emergent adverse events included constipation, dizziness, and headache, with discontinuations primarily due to dizziness and brain fog [16][17] Corporate Developments - Praxis has submitted a pre-NDA meeting request to the FDA and plans to submit the NDA by early 2026 [19][20] - The company intends to share additional data from these studies at upcoming medical conferences and peer-reviewed publications [19] Market Context - Essential tremor affects approximately seven million people in the U.S., representing a significant unmet medical need for effective therapies [22] - Current treatment options are limited, with propranolol being the only approved pharmacotherapy, highlighting the potential market opportunity for ulixacaltamide [22][23]

Axsome Therapeutics (AXSM) FY Conference Summary Company Overview - **Company**: Axsome Therapeutics - **Focus**: Development of innovative medicines for central nervous system (CNS) disorders, addressing significant unmet needs in psychiatry and neurology [2][3] Industry Context - **CNS Disorders**: Over 150 million people in the U.S. are affected by serious CNS conditions, which have been historically underserved by the biopharma industry [2][3] - **Key Conditions**: Major depressive disorder (MDD), Alzheimer's disease agitation, smoking cessation, ADHD, binge eating disorder, obstructive sleep apnea, migraine, narcolepsy, fibromyalgia, and shift work disorder [3][4] Core Strategies - **Five Pillars of Innovation**: 1. **Novel Mechanisms of Action**: Focus on distinct treatment outcomes in areas with multiple existing products [4] 2. **Multi-Mechanistic Modes of Treatment**: Examples include Ovelity and Cymbravo [5] 3. **Clinical Trial Innovation**: Designing trials to effectively detect signals from active molecules [5] 4. **Molecular Drug Delivery**: Innovative delivery methods for CNS-active molecules [6] 5. **Diversified Pipeline**: A singular neuroscience pipeline with three commercial products and multiple late-stage programs [6][7] Financial Highlights - **Potential Peak Sales**: Total potential peak sales across the pipeline estimated at $16.5 billion, with approved products like Avelity, Synoscience, and Bravo projected to reach $2 billion to $4.5 billion [8] - **Cash Position**: $300 million in cash resources as of the end of Q1, sufficient to reach cash flow positivity [39][40] Product Updates - **Ovelity**: Rapid growth with an annualized run rate of $400 million; over 50% of prescriptions are first-line treatments [11][14] - **Sunosi**: Steady growth with an annualized run rate of $100 million, focusing on potential label expansion [17] - **Simbravo**: Newly approved for acute migraine treatment, launching imminently [12][18] Clinical Trials and Regulatory Updates - **Cymbravo**: Approved earlier in the year, with positive Phase III clinical trial readouts [9] - **AXS-five**: NDA submission for Alzheimer's disease agitation on track for Q3; high unmet need with 7 million adults affected [21][22] - **Salriamfetol**: Exploring additional indications including ADHD and major depressive disorder, with ongoing trials [25][28] - **AXS-twelve**: NDA submission planned for narcolepsy in the second half of the year [33] - **AXS-fourteen**: Focused on fibromyalgia, with plans for a new 12-week fixed-dose trial following FDA feedback [35][36] Intellectual Property - **Patent Portfolio**: Broad coverage for pipeline programs, with settlements reached with multiple first filers [38] Conclusion - **Leadership and Future Outlook**: Strong leadership team and board, with a focus on providing updates throughout the year [40]

Core Insights - Cassava Sciences, Inc. is advancing the development of simufilam for TSC-related epilepsy, with plans to initiate clinical trials in the first half of 2026 following necessary pre-clinical studies and regulatory strategy development [3][6] - The company reported a net loss of $23.4 million for Q1 2025, a significant decrease from a net income of $25.0 million in the same period in 2024, primarily due to the change in fair value of warrant liabilities [6][10] - As of March 31, 2025, Cassava had cash and cash equivalents of $117.3 million, with no debt, indicating a favorable balance sheet for future developments [6][19] Business Update - Cassava has entered a license agreement with Yale University for intellectual property rights related to potential treatments for rare diseases, including TSC-related epilepsy [3][6] - The company has appointed Dr. Angélique Bordey as SVP of Neuroscience and Dr. Jack Moore as SVP of Clinical Development to enhance its team for the new TSC-related epilepsy program [3][6] - The Alzheimer's disease program, which did not meet its co-primary endpoints in Phase 3 studies, will be completely discontinued by the end of Q2 2025 [6][10] Financial Performance - Total operating expenses for Q1 2025 were $24.6 million, compared to $19.9 million in Q1 2024, reflecting increased general and administrative expenses primarily due to legal-related costs [10][17] - Research and development expenses decreased by 16% to $13.7 million in Q1 2025, down from $16.2 million in the same period in 2024, due to the discontinuation of Alzheimer's clinical trials [10][17] - General and administrative expenses rose to $10.9 million in Q1 2025, compared to $3.7 million in Q1 2024, largely due to legal expenses and the absence of insurance recoveries [10][17]