Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia Axsome Therapeutics (NASDAQ: AXSM) announced dosing of the first patient in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia on January 15, 2026. FORWARD is a multicenter, double-blind, placebo-controlled, randomized withdrawal trial that starts with a 12-week open-label AXS-14 treatment period followed by randomization 1:1 to continue AXS-14 8 mg once daily or switch to matching placebo for up to 12 weeks or until loss of therapeutic response. The primary endpoint is time from randomization to loss of therapeutic response. The design targets patients who achieve a treatment response during the open-label period and evaluates durability of effect versus placebo withdrawal.

#AXSM Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia

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Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue Axsome Therapeutics (NASDAQ: AXSM) provided preliminary unaudited net product revenue for Q4 and full year 2025. Total preliminary net product revenue was $196.0 million for Q4 2025 and $638.5 million for full year 2025, representing 65% and 66% annual growth, respectively. AUVELITY preliminary net product sales were $155.1 million for Q4 and $507.1 million for full year 2025. SUNOSI preliminary net product revenue was $36.7 million for Q4 and $124.8 million for full year 2025. SYMBRAVO preliminary sales were $4.1 million for Q4 and $6.6 million for full year 2025 after its June 2025 launch. These figures are preliminary, unaudited, and subject to completion of financial close procedures.

#AXSM Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue

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NEWS: ( NASDAQ: #AXSM ) 2 Healthcare Stocks to Buy for 2026 and Beyond

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🧬 $AXSM AXS-12 for narcolepsy receives FDA pre-NDA meeting confirmation | NDA submission January 2026 | Orphan drug designation | Pipeline expansion

🏥 $AXSM +18% | FDA accepts AXS-05 for Alzheimer's agitation with Priority Review | PDUFA target April 30, 2026 | Strong catalyst next year | Watch multiple pipeline catalysts

Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation Axsome Therapeutics (NASDAQ: AXSM) announced the FDA has accepted and granted Priority Review to its supplemental NDA for AXS-05 for treatment of Alzheimer’s disease agitation, with a PDUFA target action date of April 30, 2026.The filing follows a comprehensive clinical program including four randomized, double-blind, controlled Phase 3 trials and a long-term safety trial. The FDA previously granted Breakthrough Therapy designation for AXS-05 in June 2020. Company commentary cites that up to 76% of people with Alzheimer’s experience agitation and that approved treatments are scarce.

#AXSM Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

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Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission Axsome Therapeutics (NASDAQ: AXSM) received formal FDA pre-NDA meeting minutes supporting an NDA submission for AXS-12 (reboxetine) to treat cataplexy in narcolepsy. The FDA agreed the company’s regulatory data package would be sufficient for an NDA filing. Axsome anticipates completing the NDA submission in January 2026, with acceptance subject to the FDA’s review of the complete filing.AXS-12 clinical work includes three controlled efficacy trials and a completed long-term safety trial. AXS-12 holds Orphan Drug Designation, which may provide seven years of U.S. market exclusivity and potential user-fee waiver if approved.

#AXSM Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission

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#AXSM Axsome Therapeutics Acquires Subtype Selective GABA-A Receptor Positive Allosteric Modulator AZD7325 for the Treatment of Epilepsy

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Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Total 3Q 2025 net product revenue of $171.0 million, representing 63% year-over-year growth AUVELITY ® 3Q 2025 net product sales of $136.1 million, representing 69% year-over-year growth SUNOSI ® 3Q 2025 net product revenue of $32.8 million, representing 35% year-over-year growth SYMBRAVO ® 3Q 2025

#AXSM Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update

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Axsome (AXSM) Q2 Revenue Soars 72% | The Motley Fool

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Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Axsome Therapeutics (NASDAQ:AXSM) reported strong Q2 2025 financial results, with total net product revenue of $150.0 million, up 72% year-over-year. The company's flagship product AUVELITY achieved sales of $119.6 million (+84% YoY), while SUNOSI revenue reached $30.0 million (+35% YoY). The newly launched SYMBRAVO contributed $0.4 million since its June 10th launch.Key financial metrics include a net loss of $48.0 million ($0.97 per share) and cash reserves of $303.0 million. The company expanded AUVELITY's market access by 28 million new covered lives and signed its first GPO contract for SYMBRAVO. Axsome remains on track for upcoming regulatory submissions, including an sNDA for AXS-05 in Alzheimer's disease agitation (Q3 2025) and an NDA for AXS-12 in narcolepsy (Q4 2025). [ "Total net product revenue grew 72% YoY to $150.0 million", "AUVELITY sales increased 84% YoY to $119.6 million", "SUNOSI revenue grew 35% YoY to $30.0 million", "AUVELITY market access expanded by 28 million new covered lives", "Strong cash position of $303.0 million sufficient to fund operations to cash flow positivity", "Net loss improved from $79.3 million in Q2 2024 to $48.0 million in Q2 2025" ]

#AXSM Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

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Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline Axsome Therapeutics (NASDAQ: AXSM) is hosting its Frontiers in Brain Health R&D Day to showcase its extensive CNS pipeline. The event features presentations from six leading expert clinicians who will discuss various neurological and psychiatric conditions including Alzheimer's disease agitation, depression, narcolepsy, fibromyalgia, ADHD, and smoking cessation.Key speakers include renowned experts who will present clinical data and trial results for various drug candidates including AXS-14 for fibromyalgia, AXS-05 for Alzheimer's disease agitation, solriamfetol for ADHD and MDD, SYMBRAVO for migraine, and AXS-12 for narcolepsy. The event will be accessible via webcast for institutional investors and sell-side analysts.

#AXSM Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline

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Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today Axsome Therapeutics (NASDAQ:AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, announced that CEO Herriot Tabuteau and the management team will ring the NASDAQ opening bell on July 21, 2025. The ceremony coincides with their Frontiers in Brain Health R&D Day event.The event highlights Axsome's progress in developing late-stage CNS product candidates and celebrates the recent U.S. launch of SYMBRAVO®. The company aims to transform clinical practice in brain health through its portfolio of marketed medicines and investigational treatments for CNS conditions. The bell ringing ceremony will be held at the Nasdaq MarketSite in Times Square, New York, starting at 9:20 a.m. ET.

#AXSM Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today

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Axsome Therapeutics R&D Day: Key Opinion Leaders to Reveal Next-Gen CNS Treatment Innovations Leading neurologists unveil Axsome's latest CNS treatment advances at exclusive R&D Day. Join live webcast for groundbreaking pipeline updates. Get insights.

#AXSM Axsome Therapeutics to Showcase Its Innovative CNS Pipeline at Upcoming Frontiers in Brain Health R&D Day in New York City on July 21

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Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025 Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations at SLEEP 2025, focusing on their CNS treatments AXS-12 and solriamfetol. The presentations include two featured oral plenary sessions and multiple poster presentations taking place on June 11, 2025, in Seattle. The research covers various aspects including Phase 3 trial results of AXS-12 in narcolepsy (SYMPHONY and ENCORE trials), analysis of symptom burden in narcolepsy patients, and real-world studies of solriamfetol in treating excessive daytime sleepiness in patients with obstructive sleep apnea. Notable researchers presenting include Dr. Richard Bogan from the University of South Carolina and Dr. Michael Thorpy from the Montefiore Medical Center.

#AXSM Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025

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Revolutionary Migraine Drug SYMBRAVO Now Available: Fast-Acting Relief Targets Multiple Pain Pathways Novel migraine treatment SYMBRAVO offers rapid pain relief through multi-mechanistic approach. See how this new FDA-approved therapy helps restore normal functioning. Learn more.

#AXSM Axsome Therapeutics Announces Availability of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

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Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia Axsome Therapeutics (NASDAQ: AXSM) received a Refusal to File (RTF) letter from the FDA regarding their New Drug Application for AXS-14 (esreboxetine) for fibromyalgia management. The FDA found the application incomplete, specifically citing issues with the second placebo-controlled trial's 8-week primary endpoint and flexible-dose paradigm. The first trial, using a 12-week endpoint and fixed-dose paradigm, was deemed adequate. Notably, both trials met their primary endpoints, and the FDA didn't question the positive results. In response, Axsome will conduct an additional controlled trial with a fixed-dose paradigm and 12-week primary endpoint, planned to start in Q4 2025. The drug aims to address approximately 17 million U.S. fibromyalgia patients' needs, having shown promising results in improving pain, function, and fatigue symptoms.

#AXSM Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia

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Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting Axsome Therapeutics (NASDAQ: AXSM) is presenting data from three neuroscience programs at the ASCP 2025 Annual Meeting in Scottsdale, Arizona. The presentations include: 1. AUVELITY®: Expert panel recommendations for initiating treatment in Major Depressive Disorder (MDD) patients, presented by Dr. Anita Clayton from the University of Virginia. 2. AXS-05: Results from a Phase 3 randomized-withdrawal study on efficacy and safety in Alzheimer's Disease Agitation, presented by Dr. Jeffrey Cummings from UNLV. 3. Solriamfetol: Real-world SURWEY study data on treating excessive daytime sleepiness in narcolepsy and OSA patients with anxiety and depression, presented by Dr. Ulf Kallweit from Witten/Herdecke University.

#AXSM Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting

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Axsome Wins 17 Years of Market Exclusivity for SUNOSI in Patent Settlement with Hetero Key patent settlement blocks generic SUNOSI competition until 2040. Axsome strengthens CNS drug portfolio protection through agreement with Hetero Labs. See details.

#AXSM Axsome Therapeutics Settles SUNOSI® (solriamfetol) Patent Litigation with Hetero Labs Ltd.

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#AXSM […]

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Axsome Therapeutics Enters $570 Million Term Loan and Revolving Credit Facility with Blackstone Axsome Therapeutics (NASDAQ: AXSM) has secured a $570 million term loan and revolving credit facility with Blackstone, replacing its previous Hercules Capital term loan. The facility consists of a $500 million term loan and a $70 million revolving credit facility. The company initially drew $120 million to retire its previous loan.The new facility offers improved terms, including interest rates of SOFR plus 4.75% for the term loan and SOFR plus 4.0% for the revolving credit facility, with a 60-month interest-only period and maturity in May 2030. Additionally, Blackstone purchased $15 million of Axsome common stock at $107.14 per share. The company can access an additional $250 million at its option, with another $200 million available subject to Blackstone's approval.

#AXSM Axsome Therapeutics Enters $570 Million Term Loan and Revolving Credit Facility with Blackstone

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