Herriot Tabuteau, founder, CEO, and chairman of Axsome Therapeutics, has built one of biotech’s most closely watched companies by focusing on treatments for central nervous system disorders. A Yale-trained physician with a background in healthcare investing, he launched Axsome in 2012 and helped turn it into a major player in depression, Alzheimer’s agitation, and other brain-health markets. Known for combining scientific ambition with financial discipline, Tabuteau has emerged as one of the most notable entrepreneurs in modern neuropsychiatric drug development.
Herriot Tabuteau is a Haitian American physician, businessman and entrepreneur. He founded Axsome Therapeutics Nasdaq: AXSM in 2012.[1][2]
Biography
Dr. Herriot Tabuteau immigrated from Haiti when he was nine years old.[1] Herriot grew up on the Upper East Side of Manhattan[3] He received his medical degree from Yale University School of Medicine and his bachelor's degree in molecular biology and biochemistry from Wesleyan University.[4]
Tabuteau worked in healthcare finance prior to founding Axsome. He was a partner at hedge fund Healthco/S.A.C. Capital.[5]
He took Axsome public in 2015.[6] His 22% stake and options were worth $465 million in 2021 according to Business Insider.[6] As of 2025, he owns 15%.[2][7]
He is listed as the inventor on over 200 patents.[4]
Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a biopharmaceutical company headquartered in New York City that develops and commercializes novel therapies for central nervous system (CNS) conditions with limited treatment options.[1]The company focuses on disorders including depression, Alzheimer's disease agitation, migraine, narcolepsy, fibromyalgia, and excessive daytime sleepiness.[2]Its commercialized products include Auvelity (dextromethorphan-bupropion) for major depressive disorder, Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and Symbravo (meloxicam and rizatriptan) for migraine.[3]Axsome maintains a pipeline of additional candidates targeting multiple CNS indications, such as Alzheimer's disease agitation and excessive daytime sleepiness.[2]As of March 3, 2026, the company's stock closed at $164.05 per share with a market capitalization of approximately $8.4 billion.[4]
History
Founding and early development
Axsome Therapeutics, Inc. was incorporated on January 12, 2012, in Delaware by Herriot Tabuteau, M.D., who has served as the company's founder, Chief Executive Officer, and Chairman of the Board since inception.[5][6]Tabuteau, a physician with experience in finance and biotech investing, established the company to develop novel therapies for central nervous system (CNS) disorders and pain conditions with significant unmet medical needs, emphasizing innovative mechanisms of action and targeted approaches to address limited treatment options.[1][7]The company's initial strategy involved building a diversified portfolio of product candidates rather than focusing on a single asset, with early operations supported by self-funding from Tabuteau, friends, and family, avoiding traditional venture capital to maintain control and reduce costs through in-house clinical trial management.[7]In 2012, Axsome secured exclusive license agreements with Antecip Bioventures II LLC for intellectual property related to its early product candidates, including AXS-02 (an oral zoledronic acid formulation) and AXS-05 (a dextromethorphan-bupropion combination), laying the foundation for its pipeline.[5]Early financing consisted of convertible note issuances beginning in March 2013, with multiple rounds through mid-2015 raising approximately $17 million in aggregate principal from third-party investors, board members, officers, and related parties under terms such as 8% interest and conversion features tied to future events like an initial public offering.[5]Pre-clinical and early clinical work focused on candidates like AXS-02, including oral toxicology studies in animal models, Phase 1 pharmacokinetic trials under Health Canada, and IND preparation for U.S. studies, as well as pharmacokinetic evaluations for AXS-05 to establish dose synergies.[5]
Major milestones and product approvals
Major milestones and product approvalsAxsome Therapeutics achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approval of Auvelity (dextromethorphan-bupropion) on August 18, 2022, for the treatment of major depressive disorder (MDD) in adults. This marked a significant milestone, as the product had received Breakthrough Therapy designation from the FDA and underwent Priority Review.[8]The New Drug Application (NDA) for Auvelity (then designated AXS-05) was accepted by the FDA on February 22, 2021. Following acceptance of the NDA, Axsome anticipated commercial availability of Auvelity in the U.S. during the fourth quarter of 2022, supported by the Auvelity On My Side patient assistance program that provided savings cards, samples, and prior authorization support upon launch.[8]Another key milestone was Axsome's acquisition of U.S. rights to Sunosi (solriamfetol), an approved treatment for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The agreement with Jazz Pharmaceuticals was announced on March 28, 2022, and the transaction was completed on May 9, 2022, adding a commercial product to Axsome's portfolio and enhancing its presence in CNS disorders.[9][10]These regulatory and strategic achievements, including the successful approval and commercialization of Auvelity and the integration of Sunosi, have been instrumental in advancing Axsome's leadership in neuroscience therapeutics.
Acquisitions and strategic partnerships
Axsome Therapeutics has pursued acquisitions and strategic partnerships to expand its commercial portfolio and pipeline in central nervous system disorders.In May 2022, the company entered into a definitive agreement to acquire Sunosi (solriamfetol) from Jazz Pharmaceuticals, a product approved for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The transaction closed later that year and added Sunosi as a complementary commercial asset to Axsome's emerging portfolio, complementing its development focus on major depressive disorder including Auvelity (which was in late-stage development at the time). The deal included an upfront payment of $157.5 million in cash, up to $350 million in potential sales-based milestone payments, and tiered royalties on U.S. net sales. This acquisition supported Axsome's strategy to build a diversified CNS franchise by incorporating therapies for sleep-wake disorders.[11]Axsome has also secured licensing agreements to advance pipeline candidates in specific regions or indications. For instance, the company entered into an exclusive license agreement with Lotus Pharmaceutical for the development and commercialization of AXS-07 in certain Asian markets, enabling potential expansion beyond the U.S. while retaining core rights elsewhere. Such partnerships have helped support regional development efforts for migraine and other CNS programs without significant upfront global commitments.[12]These business development activities have been central to broadening Axsome's CNS therapeutic reach through targeted asset additions and geographic collaborations.
Products
Commercialized products
Axsome Therapeutics commercializes a portfolio of therapies targeting central nervous system (CNS) disorders, with products designed to address unmet needs in depression, sleep disorders, and migraine.[3][2]The company's marketed products include Auvelity (dextromethorphan-bupropion), Sunosi (solriamfetol), and Symbravo (meloxicam and rizatriptan). Auvelity is indicated for the treatment of major depressive disorder in adults.[13] Sunosi is indicated to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA), and is not a treatment for the underlying airway obstruction in OSA.[14] Symbravo is indicated for the acute treatment of migraine with or without aura in adults and became available by prescription in the United States in 2025.[3]Axsome has built a specialty commercial infrastructure to support its products, including patient access programs such as savings offers for eligible patients, educational resources, and tools to facilitate discussions with healthcare providers.[14][3] Sunosi was acquired by the company, expanding its presence in sleep medicine.
Auvelity (dextromethorphan-bupropion)
Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) is an oral prescription medication developed by Axsome Therapeutics and approved by the U.S. Food and Drug Administration (FDA) in 2022 for the treatment of major depressive disorder (MDD) in adults.[15][16] It is the first FDA-approved rapidly acting oral antidepressant for this indication.[16]Auvelity is a fixed-dose combination of dextromethorphan, an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone that inhibits cytochrome P450 2D6 (CYP2D6) to substantially increase dextromethorphan plasma concentrations and prolong its half-life. Bupropion also acts as a relatively weak inhibitor of norepinephrine and dopamine reuptake. The precise mechanism of action of Auvelity in treating MDD remains unclear, though it is believed to involve modulation of glutamatergic signaling via NMDA receptor antagonism and sigma-1 agonism, enhanced by bupropion's pharmacokinetic effects.[15]Approval was supported by two pivotal trials. In the phase 3 GEMINI trial (NCT04019704), a 6-week, randomized, double-blind, placebo-controlled study of adults with MDD, patients receiving Auvelity (45 mg dextromethorphan/105 mg bupropion twice daily) showed a least-squares mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score of -15.9 from baseline compared with -12.1 for placebo, yielding a statistically significant difference of -3.9 (95% CI: -6.4 to -1.4). Significant separation from placebo occurred as early as week 1. Remission rates (MADRS ≤10) at week 6 were 39.5% for Auvelity versus 17.3% for placebo, and response rates (≥50% MADRS reduction) were 54.0% versus 34.0%.[15][16]A phase 2 active-controlled trial compared Auvelity to bupropion monotherapy and demonstrated superior MADRS score reductions with the combination (least-squares mean difference of -4.9 at week 6), confirming the contribution of dextromethorphan. Long-term open-label studies such as COMET and EVOLVE showed sustained efficacy, with remission rates reaching approximately 67-69% and response rates 82% after 12 months.[16]Auvelity was generally well tolerated in clinical trials. In the GEMINI placebo-controlled study, common adverse reactions (≥5% and at least twice placebo) included dizziness (16%), headache (8%), diarrhea (7%), somnolence (7%), dry mouth (6%), sexual dysfunction (6%), and hyperhidrosis (5%). Discontinuation due to adverse reactions occurred in 4% of Auvelity patients versus 0% on placebo. Serious risks include increased suicidal thoughts in young adults, seizures, hypertension, mania activation, and serotonin syndrome; it carries boxed warnings for suicidality and is contraindicated in patients with seizure disorders or certain eating disorders.[15][16]Auvelity is administered as one tablet (45 mg dextromethorphan/105 mg bupropion) once daily in the morning for the first three days, then twice daily at least eight hours apart. It is indicated for adult MDD and represents a novel approach targeting glutamatergic pathways for potentially faster symptom relief compared to traditional antidepressants.[15]
Sunosi (solriamfetol)
Sunosi (solriamfetol) is a wake-promoting medication used to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).[17] Axsome Therapeutics commercializes Sunosi in the United States following its acquisition from Jazz Pharmaceuticals in 2022.[18]Solriamfetol functions as a selective dopamine and norepinephrine reuptake inhibitor (DNRI). Its precise mechanism for promoting wakefulness is not fully understood but is believed to involve inhibition of dopamine and norepinephrine reuptake.[18] It has minimal activity at serotonin transporters and does not significantly interact with other major neurotransmitter receptors.[18]The FDA approved Sunosi in 2019 for the treatment of EDS in adults with narcolepsy or OSA. It is not indicated to treat the underlying airway obstruction in OSA.[18]Clinical trials demonstrated Sunosi's efficacy in improving and sustaining wakefulness. In studies measured at 12 weeks, Sunosi provided improved wakefulness lasting through 9 hours post-dose.[17] In patients with OSA, treatment with Sunosi 150 mg resulted in a higher percentage of individuals reporting overall improvement compared to placebo (where 49% on placebo reported improvement), along with greater increases in time awake (versus 2% on placebo) and enhancements in daily activities, work performance, and well-being.[19] Similar wake-promoting effects were observed in narcolepsy populations, supporting its role in managing EDS across these conditions.[17]
Pipeline
Late-stage pipeline candidates
Axsome Therapeutics maintains a late-stage pipeline focused on novel therapies for central nervous system disorders, with candidates in Phase 3 development or NDA preparation stages.AXS-14 (esreboxetine), a selective norepinephrine reuptake inhibitor, is being developed for the treatment of fibromyalgia. It demonstrated positive results in earlier trials, but the company's NDA submission in May 2025 received a Refusal to File letter from the FDA in June 2025 due to inadequacy in one of the submitted studies. To address this, Axsome initiated the Phase 3 FORWARD trial (a double-blind, placebo-controlled randomized withdrawal study) in January 2026.[20][21]AXS-12 (reboxetine), another selective norepinephrine reuptake inhibitor, is in Phase 3 development for narcolepsy. It has demonstrated positive preclinical and Phase 2 clinical results, and has received FDA Orphan Drug designation for this indication.[22]AXS-05 (dextromethorphan-bupropion), an oral NMDA receptor antagonist with multimodal activity, is in development for Alzheimer's disease agitation, where it has received Breakthrough Therapy designation from the FDA. It is also under investigation for smoking cessation.[23]Note that AXS-07 (Symbravo; meloxicam-rizatriptan) received FDA approval in January 2025 for the acute treatment of migraine with or without aura and is now commercialized, rather than remaining in late-stage development.[24][25]
Early-stage and exploratory programs
Axsome Therapeutics' early-stage and exploratory programs focus on preclinical candidates and early clinical development to expand its presence in central nervous system (CNS) disorders, including emerging indications and novel mechanisms.A prominent early-stage program is AXS-17, acquired in November 2025 as AZD7325 and redesignated by Axsome. This novel oral GABAA receptor α2/3 subtype-selective positive allosteric modulator is being developed for epilepsy, representing the company's initial foray into this therapeutic area. As of February 2026, Axsome had initiated technology transfer and Phase 2 trial-enabling activities for AXS-17.[26]Exploratory development is also underway for certain indications of existing pipeline candidates. AXS-05 (dextromethorphan-bupropion), which combines NMDA receptor antagonism with sigma-1 receptor agonism and enhanced bioavailability via bupropion, is under investigation for smoking cessation as an exploratory indication separate from its more advanced development in other areas.[23]These programs reflect Axsome's strategy to advance innovative, patent-protected assets addressing unmet needs in neurological and psychiatric conditions through targeted acquisitions and targeted research efforts.[2][26]
Research and development
Therapeutic focus on CNS disorders
Axsome Therapeutics concentrates its research and development efforts on central nervous system (CNS) disorders that have significant unmet medical needs and limited effective treatment options.[1] The company's primary therapeutic focus encompasses major depressive disorder, sleep disorders including narcolepsy and excessive daytime sleepiness, migraine, agitation associated with Alzheimer's disease, fibromyalgia, and related conditions such as smoking cessation.[27][28]Axsome pursues innovative mechanisms of action to address the complex pathophysiology of these disorders. A key aspect of its approach involves modulation of glutamatergic neurotransmission through NMDA receptor antagonism and sigma-1 receptor agonism, which target ionotropic glutamate receptors and related pathways implicated in mood, cognition, and other CNS functions.[23] The company also leverages monoaminergic mechanisms, including inhibition of norepinephrine and dopamine reuptake, to influence neurotransmitter balance in conditions involving mood regulation and arousal.[23]This multimodal strategy reflects Axsome's emphasis on developing differentiated therapies that target core neurochemical imbalances underlying CNS disorders, aiming to improve patient outcomes in areas with persistent treatment gaps.[1][28]
Clinical trials and collaborations
Axsome Therapeutics conducts clinical trials primarily through multi-center study designs, including randomized, double-blind, placebo-controlled trials and randomized withdrawal studies, to evaluate safety and efficacy in central nervous system disorders. These trials are sponsored by the company and registered on ClinicalTrials.gov, encompassing phase 2, phase 3, and open-label extension studies across indications such as Alzheimer's disease agitation, narcolepsy, and fibromyalgia.[29][30][31]The company has engaged in academic collaborations to support specific research efforts. Notably, Axsome partnered with Duke University for preclinical and clinical research on AXS-05 (dextromethorphan-bupropion), including a Phase II trial in smoking cessation conducted at the Duke Center for Smoking Cessation.[32][33]Axsome has also secured license agreements to access foundational data for its pipeline. In 2020, the company entered an exclusive U.S. license agreement with Pfizer for nonclinical and clinical data on reboxetine and esreboxetine, supporting the development of AXS-14 (esreboxetine) for fibromyalgia.[34]Additional partnerships focus on regional expansion and supporting further development, including a 2023 license agreement with Pharmanovia to commercialize and potentially develop Sunosi (solriamfetol) in Europe.[35]Recent trial initiations include the FORWARD Phase 3 trial of AXS-14 in fibromyalgia (first patient dosed January 2026) and the CLARITY Phase 3 trial of solriamfetol in adults with major depressive disorder and excessive daytime sleepiness symptoms (first patient dosed February 2026).[36]
Leadership and governance
Executive team
Axsome Therapeutics' executive team is led by Herriot Tabuteau, MD, the company's founder, Chief Executive Officer, and Chairman of the Board of Directors, positions he has held since the company's founding in January 2012.[6]Nick Pizzie, CPA, MBA, serves as Chief Financial Officer and Principal Accounting Officer, a role he has occupied since May 2018.[6]Mark Jacobson, MA, is Chief Operating Officer, having assumed this position in March 2020 after joining the company in April 2014.[6]Ari Maizel is Chief Commercial Officer, appointed in October 2024 after joining Axsome in October 2023.[6]Hunter Murdock, Esq., serves as General Counsel, a position he has held since June 2022, following his initial entry to the company in December 2021.[6]These executives oversee the company's strategic direction, financial management, operations, commercial activities, and legal affairs in support of its focus on developing and commercializing therapies for central nervous system disorders.[6]
Board of directors
Axsome Therapeutics' Board of Directors provides oversight of the company's strategic direction, risk management, financial reporting, and executive performance. The Board consists of five members, four of whom qualify as independent under Nasdaq listing standards.[37]The Board maintains three standing committees, each composed solely of independent directors: the Audit Committee (chaired by Mark Saad), the Compensation Committee (chaired by Mark Coleman, M.D.), and the Nominating and Corporate Governance Committee (chaired by Roger Jeffs, Ph.D.). The Audit Committee oversees financial reporting, internal controls, and audit processes, with Mark Saad serving as the designated financial expert.[37]Herriot Tabuteau, M.D., serves as Chairman of the Board, President, and Chief Executive Officer. He founded Axsome Therapeutics in January 2012 and has led the company since inception. Prior to founding Axsome, he held roles in healthcare investment, including as a senior analyst and partner at HealthCor (S.A.C. Capital), analyst at Kingdon Capital, senior research analyst at Banc of America Securities, and in healthcare investment banking at Goldman Sachs. He also manages Antecip Capital LLC and Antecip Bioventures II LLC. He earned his M.D. from Yale University School of Medicine and a B.A. in molecular biology and biochemistry from Wesleyan University.[37]Roger Jeffs, Ph.D., has been a director since December 2014. He currently serves as CEO of Liquidia Corporation and co-founder and Vice Chairman of Kriya Therapeutics. Previously, he spent nearly two decades at United Therapeutics Corporation (1998–2016), where he held positions including Director of Research, Development, and Medical; President and COO; President and co-CEO; and board member. He contributed to the company's IPO, clinical development of six products, and growth to over $1.5 billion in revenue. Earlier roles included positions at Amgen and Burroughs Wellcome. He holds a Ph.D. in pharmacology from the University of North Carolina School of Medicine and a B.S. in chemistry from Duke University.[37]Susan Mahony, Ph.D., MBA, has been a director since October 2023. She previously served as President of Lilly Oncology at Eli Lilly and Company (2011–2018) and as Senior Vice President at Lilly (2009–2011), where she led the global development and commercialization of multiple oncology products. She held various leadership roles at Eli Lilly across regions including Europe, the US, Canada, Japan, and China. Earlier positions included roles at Bristol Myers Squibb, Amgen, and Schering Plough. She earned a Ph.D. in Oncology and B.S. in Pharmacy from the University of Aston (UK) and an MBA from the London Business School.[37]Mark Saad has been a director since December 2014. He is CEO of NuLids, LLC, and an advisor to Alethea Capital Management, LLC. Previously, he served as CFO of Bird Rock Bio, Inc. (2014–2017) and Cytori Therapeutics (2004–2014). He held executive roles in healthcare investment banking at UBS (as COO of Global Healthcare Group) and Salomon Smith Barney. He earned a B.A. from Villanova University and qualifies as an Audit Committee financial expert.[37]Mark Coleman, M.D., has been a director since December 2014 (having served as a consultant to the company from 2012–2014). He is Medical Director at National Spine and Pain Centers, where he previously served as President and Director of Clinical Services. He has expertise in pain management and anesthesiology. He earned an M.D. from Johns Hopkins University School of Medicine and a B.A. from Wesleyan University.[37]The Board's composition reflects diverse expertise in biotechnology leadership, pharmaceutical development, finance, investment, and clinical medicine, aligning with the company's focus on central nervous system disorders.[37]
Financial performance
Stock performance and market data
Axsome Therapeutics, Inc. trades on the Nasdaq Global Market under the ticker symbol AXSM.[^(https://finance.yahoo.com/quote/AXSM/)]As of March 3, 2026 (most recent closing data), the stock closed at $164.05 per share, with a market capitalization of approximately $8.4 billion.[^(https://finance.yahoo.com/quote/AXSM/)] [^(https://www.macrotrends.net/stocks/charts/AXSM/axsome-therapeutics/stock-price-history)]Year-to-date performance for 2026 was +10.18%, while the 52-week change was +31.14%.[^(https://finance.yahoo.com/quote/AXSM/)]
Revenue and capitalization metrics
Axsome Therapeutics generates the majority of its revenue from net product sales of its two commercialized CNS therapies: Auvelity (dextromethorphan and bupropion) for major depressive disorder and Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.[38][39]In full year 2024, total net product revenues reached $385.7 million, an 88% increase year-over-year, with Auvelity contributing $291.4 million (124% growth) and Sunosi contributing $94.3 million (26% growth). Auvelity's strong performance was driven by significant prescription growth and expanded payer coverage, while Sunosi exhibited more moderate but steady gains.[38]For full year 2025, net revenue grew to $638.5 million, representing approximately 66% year-over-year growth, again primarily driven by Auvelity and Sunosi. The company has continued to report net losses as it invests heavily in research and development and commercial expansion, with 2024 R&D expenses totaling $187.1 million and a full-year net loss of $287.2 million.[40][38]As of March 3, 2026, Axsome Therapeutics had a market capitalization of approximately $8.4 billion, underscoring investor confidence in its revenue trajectory from commercial products and potential from its late-stage CNS pipeline despite ongoing operating losses. The company's capitalization remains predominantly equity-based, supported by cash reserves and capital raises to fund growth initiatives.