FOCUS is a randomized, double-blind, placebo-controlled crossover pilot study evaluating Tonix’s investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D)The trial is intended to generate preliminary data to inform future potential clinical studies of oxytocin replacement therapy in AVP-D CHATHAM, N.J., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated biotechnology compa ...

Core Insights - Axsome Therapeutics' lead drug, Auvelity, has shown strong sales performance since its approval for major depressive disorder, contributing significantly to the company's revenue [1] Sales Performance - Auvelity recorded sales of $215.9 million in the first half of 2025, marking an 82.3% increase year-over-year, driven by higher unit sales volume [2][9] - The company anticipates a compound annual growth rate (CAGR) of approximately 42.7% for Auvelity sales over the next three years [2] Product Development and Expansion - Auvelity is undergoing label expansion studies for other CNS disorders, including Alzheimer's disease agitation and smoking cessation, with an sNDA expected to be filed in Q3 2025 [3] - A pivotal phase II/III study for smoking cessation is planned to commence in Q4 2025 [3] - The approval of Auvelity for additional indications is expected to further enhance sales and growth prospects [4] Additional Products - Axsome's narcolepsy drug, Sunosi, has also contributed to revenue, with sales increasing by 25.6% year-over-year in H1 2025 [5][9] - The recent launch of Symbravo for migraine treatment, approved in January 2025, is expected to strengthen Axsome's market presence [5] Competitive Landscape - Axsome faces significant competition in the CNS disorder market, particularly from Acadia Pharmaceuticals' Nuplazid, which generated $328.2 million in sales, a 14% increase year-over-year [6][7] - Sunosi may encounter competition from Jazz Pharmaceuticals' sleep disorder drugs, while Symbravo will face established migraine treatments from Pfizer and AbbVie [8]

Core Viewpoint - Axsome Therapeutics has shown strong stock performance, with a 20.2% increase over the past month, significantly outperforming the industry and the S&P 500 [1][7]. Sales Performance - The lead drug, Auvelity, has generated $215.9 million in sales during the first half of 2025, marking an 82.3% year-over-year increase, primarily due to higher unit sales volume [3][7]. - Auvelity is expected to maintain a compound annual growth rate (CAGR) of approximately 42.7% over the next three years [3]. Drug Development and Pipeline - Axsome is expanding Auvelity's indications for other CNS disorders, including Alzheimer's disease agitation and smoking cessation, with plans to submit a supplemental new drug application (sNDA) later in Q3 2025 [4]. - The company is also advancing its other drugs, such as Sunosi, which generated $53 million in sales in H1 2025, reflecting a 25.6% year-over-year increase [8]. - New migraine drug Symbravo was approved in January 2025 and launched in June, enhancing Axsome's market presence [9]. Competitive Landscape - Competition exists in the CNS market, with companies like Acadia Pharmaceuticals developing similar treatments [11]. - Sunosi may face competition from Jazz Pharmaceuticals' sleep disorder drugs, which have a strong market share [12]. Regulatory Challenges - Axsome received a Refusal to File letter from the FDA regarding its NDA for AXS-14, which could delay potential approval and market entry [13]. Valuation Metrics - Axsome's shares are trading at a price-to-sales (P/S) ratio of 12.16, significantly higher than the industry average of 2.12, although below its five-year mean of 14.93 [14]. Earnings Estimates - The Zacks Consensus Estimate for 2025 loss per share has widened from $3.26 to $3.41, while 2026 earnings per share estimates have decreased from $1.36 to $0.92 [16]. Conclusion - The strong sales performance of Auvelity and the progress of other drugs are positive indicators for Axsome's stock [17]. - However, competition and potential regulatory setbacks pose risks to growth prospects [17].

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully integrated biotechnology company focused on pain management therapies and vaccines for public health challenges [3] - The company has a development portfolio primarily targeting central nervous system (CNS) disorders [3] Key Product Candidates - TNX-102 SL is a product candidate for fibromyalgia management, with an NDA submitted based on two statistically significant Phase 3 studies, and a PDUFA goal date of August 15, 2025 [3] - TNX-102 SL has received Fast Track designation from the FDA for fibromyalgia management [3] - The company is also developing TNX-102 SL for acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina [3] Immunology and Infectious Disease Portfolio - Tonix's immunology portfolio includes TNX-1500, an Fc-modified humanized monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases [3] - The infectious disease portfolio features TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million over five years with the U.S. Department of Defense [3] Commercial Products - Tonix Medicines, the commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) and Tosymra (sumatriptan nasal spray) for treating acute migraine in adults [3]

Financial Performance - Total net product revenue for Q1 2025 was $121.5 million, reflecting a 62% increase year-over-year from $75.0 million in Q1 2024 [4] - AUVELITY® generated net product sales of $96.2 million in Q1 2025, an 80% increase from $53.4 million in Q1 2024 [4] - SUNOSI® reported net product revenue of $25.2 million in Q1 2025, a 17% increase from $21.6 million in Q1 2024 [4] - The net loss for Q1 2025 was $59.4 million, or $(1.22) per share, compared to a net loss of $68.4 million, or $(1.44) per share, in Q1 2024 [11] Product Developments - SYMBRAVO® received FDA approval for the acute treatment of migraine, with a commercial launch expected in June 2025 [3][8] - NDA for AXS-14 for fibromyalgia management has been submitted to the FDA, with a decision anticipated in Q2 2025 [3][19] - Supplemental NDA for AXS-05 in Alzheimer's disease agitation is on track for submission in Q3 2025 [3][16] - NDA submission for AXS-12 for cataplexy in narcolepsy patients is expected in the second half of 2025 [3][18] Clinical Trials and Pipeline - Positive topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD were announced, with plans to initiate a Phase 3 trial in pediatric patients in 2025 [13] - A Phase 3 trial of solriamfetol in major depressive disorder with excessive daytime sleepiness is also anticipated in 2025 [13] - The EMERGE Phase 3 trial of SYMBRAVO in migraine patients with inadequate response to oral CGRP inhibitors showed positive results [14] Market Position and Coverage - Approximately 167,000 prescriptions for AUVELITY were written in Q1 2025, a 76% increase year-over-year [12] - Payer coverage for AUVELITY is approximately 78% across all channels, with 63% in commercial and 100% in government channels [12] - SUNOSI had about 46,000 prescriptions written in Q1 2025, a 12% increase year-over-year [12] Financial Guidance and Cash Position - The company believes its current cash position of $300.9 million is sufficient to fund operations until reaching cash flow positivity [5] - Total cost of revenue for Q1 2025 was $9.8 million, up from $6.3 million in Q1 2024 [4]