Key Takeaways AXSM reported a Q4 loss of 71 cents, missing estimates even as revenues rose 65% to $196M.Auvelity sales climbed 68% Y/Y to $155.1M, with prescriptions up 42% year over year in Q425.Axsome's Sunosi sales rose 40% Y/Y, while newly launched Symbravo generated $4.1M in Q4.Axsome Therapeutics (AXSM) incurred a loss of 71 cents per share in the fourth quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 70 cents. The company had incurred a loss of 96 cents per share in the year-ago ...

Core Insights - Axsome Therapeutics is experiencing significant sales growth for its lead drug, Auvelity, which is approved for major depressive disorder, contributing substantially to the company's revenue since its U.S. launch in 2022 [1][11] Sales Performance - Auvelity generated sales of $352 million in the first nine months of 2025, marking a 77% increase year-over-year, primarily due to higher unit sales volume [2][11] - Total product revenues are projected to be approximately $196 million for Q4 2025 and around $638.5 million for the full year, reflecting year-over-year increases of 65% and 66%, respectively [3] - Auvelity's net product sales are expected to reach about $155.1 million for Q4 2025 and $507.1 million for the full year [4] Product Development and Regulatory Updates - The FDA has accepted a supplemental new drug application (sNDA) for AXS-05 to treat agitation in Alzheimer's disease, with a decision expected by April 30, 2026 [5][11] - Auvelity is also being studied for label expansions in other CNS disorders, which could broaden its market reach and enhance future sales [4][5] Additional Products and Market Position - Axsome's narcolepsy drug, Sunosi, is contributing to revenue growth, with sales increasing by 29.1% year-over-year in the first nine months of 2025 [6][7] - Sunosi's net product revenues are anticipated to be around $36.7 million for Q4 2025 and $124.8 million for the full year [7] - The newly launched Symbravo, approved for migraine treatment, is expected to generate net product sales of approximately $4.1 million for Q4 2025 and $6.6 million for the full year [8] Competitive Landscape - The competitive environment remains challenging, with companies like Acadia Pharmaceuticals marketing therapies for CNS disorders, including its drug Nuplazid, which recorded sales of $505.7 million in the first nine months of 2025 [9][10] - Symbravo is likely to face competition from established migraine treatments from Pfizer and AbbVie, which may hinder its market adoption [12]

Core Insights - Praxis Precision Medicines, Inc. has announced key leadership appointments to enhance its strategic direction as it prepares for commercial launch and late-stage development [1][2] Leadership Appointments - Jeffrey B. Kindler has been appointed to the board, bringing extensive experience in enterprise leadership and strategic transactions from his tenure as former chairman and CEO of Pfizer [3] - Stuart Arbuckle joins the board with a strong background in global commercial success, having spent 13 years at Vertex Pharmaceuticals, where he played a pivotal role in the company's growth [5] - Megan Sniecinski has been promoted to Chief Operating Officer, responsible for operationalizing the company's growth strategy and overseeing program strategy and operations [8][9] - Dr. Steven Petrou has been promoted to President of Research & Development, reflecting the company's transition into late-stage development with multiple programs advancing toward commercialization [9][10] Strategic Vision - The leadership changes are aimed at optimizing value-creation pathways for Praxis as it enters a critical phase of growth, focusing on commercial launch planning and execution readiness [2][4] - The company is positioned to become a leading CNS company with a pipeline of multi-billion dollar drugs and innovative therapies targeting severe neurological disorders [7] Pipeline and Development - Praxis has a diversified CNS portfolio, including multiple clinical-stage product candidates, and is leveraging genetic insights to develop therapies for both rare and prevalent neurological disorders [12]

Core Insights - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing and marketing products for various medical conditions, including fibromyalgia and acute migraine [3]. Company Overview - Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [3]. - The company markets two treatments for acute migraine in adults and has a diverse development portfolio targeting central nervous system disorders, immunology, rare diseases, and infectious diseases [3]. - Key products in development include TNX-102 SL for acute stress reaction and major depressive disorder, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-2900 for Prader-Willi syndrome [3]. - Tonix is also developing vaccines and monoclonal antibodies for infectious diseases, including TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3]. - The company has a contract with the U.S. Department of Defense for TNX-4200, a broad-spectrum antiviral agent, valued at up to $34 million over five years [3]. Upcoming Events - Seth Lederman, M.D., the CEO of Tonix, will present at the Stifel 2025 Healthcare Conference on November 13, 2025 [1][2]. - Investors can arrange meetings with the company's management during the conference through their Stifel representative [2]. Additional Information - A webcast of the presentation will be available on the company's website, with a replay accessible for 90 days post-event [2]. - Tonix operates a state-of-the-art infectious disease research facility in Frederick, Maryland [3].

Core Insights - Axsome Therapeutics has acquired exclusive global rights to AZD7325, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator, from AstraZeneca, enhancing its neuroscience portfolio and targeting epilepsy treatment [1][2][3] Company Overview - Axsome Therapeutics is focused on developing innovative treatments for central nervous system disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder, narcolepsy, and migraine, as well as multiple late-stage development programs [5] Transaction Details - The acquisition was executed through Axsome's purchase of a 100% equity interest in Baergic Bio, Inc., which includes a $0.3 million upfront payment to Baergic Bio shareholders and potential milestone payments totaling up to $79 million [3] - AstraZeneca will receive a cash upfront payment in the single-digit millions and is eligible for additional milestone payments and royalties on global net sales of AZD7325 [3] Clinical Development - AZD7325 has shown anti-convulsant effects in preclinical models and has a favorable safety profile based on studies involving over 700 patients [2] - Axsome plans to initiate Phase 2 trial-enabling activities for AZD7325 in 2026 [1][2] Market Need - Epilepsy affects approximately 3.4 million people in the U.S., with about 150,000 new cases diagnosed annually, highlighting the urgent need for innovative treatment options [4]

Core Insights - Praxis Precision Medicines announced positive results from two pivotal Phase 3 Essential3 studies of ulixacaltamide HCl in essential tremor, with a pre-NDA meeting with the FDA scheduled for Q4 2025 [1][2] - The company plans to accelerate the development of relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies (DEE) after a comprehensive Type B meeting with the FDA [1][2] - Recruitment for the POWER1 study of vormatrigine in focal onset seizures has been completed, with topline results expected in the first half of 2026, while the POWER2 study has commenced [1][2] Clinical Development Updates - Ulixacaltamide demonstrated significant improvements in symptoms for essential tremor, with a mean improvement of 4.3 points in the modified Activities of Daily Living 11 (mADL11) at Week 8 [3][4] - The first study met all primary and secondary endpoints, while the second study showed 55% of patients on ulixacaltamide maintained their response compared to 33% on placebo [3][4] - Vormatrigine showed a 56.3% median reduction in seizure frequency in the RADIANT study, with 22% of patients achieving a 100% reduction in the last 28 days [4][15] Financial Overview - As of September 30, 2025, Praxis had $389.2 million in cash and marketable securities, down from $469.5 million at the end of 2024, primarily due to cash used in operating activities [6][7] - The company completed a public offering in October 2025, generating net proceeds of approximately $567 million, expected to fund operations into 2028 [7][8] - Research and development expenses increased to $65.8 million for Q3 2025, up from $41.9 million in Q3 2024, largely due to investments in the Cerebrum™ platform [9][10] Market Position and Future Prospects - Praxis is positioned to establish itself as a leader in innovative therapies for CNS disorders, with multiple clinical-stage product candidates across movement disorders and epilepsy [2][18] - The company is on track to nominate development candidates for early-stage antisense oligonucleotide (ASO) therapeutic initiatives in the first half of 2026 [13][18] - The EMBOLD study for relutrigine is expected to provide substantial evidence for NDA submission in early 2026, contingent on a successful interim analysis [4][16]

Core Insights - Minerva Neurosciences, Inc. reported business updates and financial results for Q3 2025, highlighting significant financing and clinical trial advancements [1][3]. Business Updates - The company secured $80 million in gross proceeds from a private placement on October 23, 2025, with potential additional proceeds of up to $120 million contingent on warrant exercises related to its Phase 3 trial for roluperidone in schizophrenia [2]. - The CEO emphasized the alignment with the FDA on the Phase 3 clinical trial and expressed confidence in funding the study and preparing for a potential commercial launch of roluperidone in the US [3]. Financial Results - Research and Development (R&D) expenses for Q3 2025 were $0.9 million, down from $1.9 million in Q3 2024, primarily due to reduced costs in drug substance validation and consultant fees [4]. - General and Administrative (G&A) expenses for Q3 2025 were $1.9 million, a decrease from $2.5 million in Q3 2024, attributed to lower professional service fees [5]. - The company reported a net loss of $2.7 million for Q3 2025, compared to a net income of $22.5 million in Q3 2024, reflecting a significant change in financial performance [8]. - Cash and cash equivalents as of September 30, 2025, were approximately $12.4 million, down from $21.5 million at the end of 2024 [9]. Balance Sheet Highlights - Total assets decreased to $28.1 million as of September 30, 2025, from $37.1 million in 2024 [14]. - Total liabilities were reported at $62.7 million, slightly down from $62.8 million in the previous year [14].

Core Insights - Axsome Therapeutics reported a total net product revenue of $171.0 million for Q3 2025, reflecting a 63% year-over-year growth and a 14% sequential growth from Q2 2025 [3] - The company has submitted a supplemental NDA for AXS-05 for the treatment of Alzheimer's disease agitation, addressing a significant unmet medical need [2][11] Financial Highlights - Total net product revenue for Q3 2025 was $171.0 million, up from $104.8 million in Q3 2024, marking a 63% increase year-over-year [3] - AUVELITY sales reached $136.1 million in Q3 2025, a 69% increase from $80.4 million in Q3 2024 [3] - SUNOSI generated $32.8 million in revenue for Q3 2025, representing a 35% year-over-year growth [3] - SYMBRAVO achieved $2.1 million in sales during its first full quarter of commercialization [3] - The net loss for Q3 2025 was $47.2 million, or $(0.94) per share, an improvement from a net loss of $64.6 million, or $(1.34) per share, in Q3 2024 [3] Commercial Highlights - AUVELITY prescriptions increased by 46% year-over-year, totaling approximately 209,000 in Q3 2025 [9] - Payer coverage for AUVELITY is approximately 85%, with 75% in commercial channels and 100% in government channels [9] - SUNOSI prescriptions rose by 12% year-over-year, with approximately 53,000 prescriptions written in Q3 2025 [9] - SYMBRAVO had approximately 5,000 prescriptions written in its first full quarter [9] Development Pipeline - AXS-05 is being developed for Alzheimer's disease agitation and has received FDA Breakthrough Therapy designation [11] - Axsome plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in Q4 2025 [12] - AXS-12 is set for NDA submission for the treatment of cataplexy in narcolepsy in Q4 2025 [13] - A Phase 3 trial of AXS-14 in fibromyalgia is also planned for Q4 2025 [17] Cash Position - Cash and cash equivalents totaled $325.3 million as of September 30, 2025, compared to $315.4 million at the end of 2024 [8]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated commercial biopharmaceutical company with marketed products and a pipeline of development candidates [3] - The company has received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first approval for a new prescription medicine for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [3] Pipeline and Development - The company’s development portfolio includes TNX-102 SL for acute stress reaction and major depressive disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio features TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases [3] - The rare disease portfolio includes TNX-2900 for Prader-Willi syndrome, while the infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3] - TNX-4200 is a broad-spectrum antiviral agent with a contract from the U.S. DoD for up to $34 million over five years [3] Upcoming Events - Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present at BIO-Europe 2025 on November 4, 2025, highlighting the company's strategy and pipeline [1][2]

Core Insights - Tonix Pharmaceuticals is conducting a pilot study named FOCUS to evaluate its investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D), a rare endocrine disorder linked to oxytocin deficiency and mental health issues [1][2] Group 1: Study Overview - The FOCUS study is a randomized, double-blind, placebo-controlled crossover trial aimed at generating preliminary data for future clinical studies on oxytocin replacement therapy in AVP-D [1][2] - The study will assess the effects of two different doses of investigational intranasal oxytocin products (6 IU, TNX-2900 and 24 IU, TNX-1900) on anxiety, depression, and socioemotional functioning in patients with AVP-D [2] Group 2: Product Information - TNX-1900 and TNX-2900 are based on Tonix's patented intranasal magnesium-potentiated oxytocin formulations, designed to enhance oxytocin receptor binding and its effects on trigeminal neurons [3] - TNX-1900 is being developed for chronic migraine prevention, while TNX-2900 targets Prader-Willi syndrome in children and adolescents [3] Group 3: Company Background - Tonix Pharmaceuticals is a fully integrated biotechnology company with a focus on central nervous system disorders, immunology, and rare diseases, among other areas [10] - The company has 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 [10]