Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) disorders in the United States. Its product pipeline includes AXS-05 for the treatment major depressive disorder and resistant depression disorders; and that is in the Phase III clinical trial for the treatment of Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation. The company is also developing AXS-07 for the treatment of migraine; AXS-12 for the treatment of narcolepsy; and AXS-14 for the treatment of fibromyalgia. Axsome Therapeutics, Inc. has a research collaboration agreement with Duke University for evaluating AXS-05 in smoking cessation. The company was incorporated in 2012 and is based in New York, New York.
IPO Year: 2015
Exchange: NASDAQ
Website: axsome.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/3/2025 | $190.00 | Overweight | Morgan Stanley |
| 6/3/2025 | $185.00 | Outperform | Oppenheimer |
| 4/7/2025 | $200.00 | Buy | Jefferies |
| 2/11/2025 | $176.00 | Buy | Deutsche Bank |
| 12/31/2024 | $124.00 → $122.00 | Outperform | Mizuho |
| 9/3/2024 | $140.00 | Overweight | Wells Fargo |
| 8/6/2024 | $95.00 → $106.00 | Neutral → Buy | BofA Securities |
| 7/22/2024 | $130.00 | Buy | Needham |
| 4/29/2024 | $90.00 → $115.00 | Equal-Weight → Overweight | Morgan Stanley |
| 3/19/2024 | $108.00 | Outperform | Robert W. Baird |
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Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% sequentially AUVELITY® 2Q 2025 net product sales of $119.6 million, representing growth of 84% year-over-year and 24% sequentially SUNOSI® 2Q 2025 net product revenue of $30.0 million, representing growth of 35% year-over-year and 19% sequentially SYMBRAVO® launched June 10th, with 2Q 2025 net product sales of $0.4 million AUVELITY® market access expanded by 28 million new covered lives in the commercial channel First group purchasing organization (GPO) contract for SYMBRAVO® signed Supplemental NDA submission for AXS-05 in Alzheimer's disease agit
Comprehensive review of broad pipeline targeting Alzheimer's disease agitation, depression, narcolepsy, fibromyalgia, ADHD, and smoking cessation, with new data analyses Presentations by expert clinicians and key opinion leaders Company to webcast its R&D Day event today at 11:00 AM Eastern NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host its Frontiers in Brain Health R&D Day today in New York City to review its industry-leading CNS pipeline. The Frontiers in Brain Health R&D Day will feature presentations from the following six leading
NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome's Chief Executive Officer, along with the rest of the management team, and other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Monday, July 21, 2025, in connection with its Frontiers in Brain Health R&D Day event being held today. Herriot Tabuteau, MD, Chief Executive Officer of Axsome said, "We are thrilled to ring NASDAQ's opening bell in connection with our Frontiers in Brain Health R&D Day today, showcasing our p
NEW YORK, July 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2025 on Monday, August 4, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts & Presentat
NEW YORK, July 07, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it will host its Frontiers in Brain Health R&D Day on July 21, 2025, starting at 11:00 a.m. Eastern Time in New York City. The event will highlight Axsome's singular, innovative late-stage CNS pipeline. At the event, physician key opinion leaders will discuss the company's current indications in neurology and psychiatry. Members of the Axsome management team will provide an overview of the clinical development programs. The presenters will be available to answer questions at the e
NEW YORK, June 20, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today is joining with the Alzheimer's disease advocacy community to raise awareness of the growing impact of Alzheimer's disease in the United States and the importance of brain health during this year's Alzheimer's & Brain Awareness Month. "Alzheimer's & Brain Awareness Month offers the perfect opportunity for all Americans to take charge of their brain health," said Sarah Fried, Vice President of Corporate Initiatives at the Alzheimer's Association. "For the first time ever there are now more than 7
NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that data from across the SYMBRAVO® (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota. Details for the presentations are as follows: Title: Efficacy of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) by Baseline Migraine-Associated Disability: Post-Hoc Analysis of the INTERCEPT TrialLead Author: Stewart Tepper, MD, Clinical Pro
NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, is proud to recognize Migraine and Headache Awareness Month alongside the Association of Migraine Disorders. In honor of this year's theme, "Your Path to Better Days," Axsome is supporting more than a dozen Miles for Migraine Run, Walk or Relax events across the U.S. throughout the month of June and beyond. Axsome is also sharing resources for patients and their loved ones affected by migraine. "As someone who lives with migraine, I know how isolating, debilitating, and misunderstood this disease can
NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington. Details for the presentations are as follows: AXS-12 Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in NarcolepsyLead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor
SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that addresses multiple pathways underlying a migraine attack SYMBRAVO On My Side offers comprehensive patient support services including access and prescription drug support NEW YORK, June 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that SYMBRAVO® (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults.1 SYMBRAVO represents a novel multi-mechanistic approach to treating migra
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Morgan Stanley resumed coverage of Axsome Therapeutics with a rating of Overweight and set a new price target of $190.00
Oppenheimer initiated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $185.00
Jefferies initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $200.00
Deutsche Bank initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $176.00
Mizuho reiterated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $122.00 from $124.00 previously
Wells Fargo initiated coverage of Axsome Therapeutics with a rating of Overweight and set a new price target of $140.00
BofA Securities upgraded Axsome Therapeutics from Neutral to Buy and set a new price target of $106.00 from $95.00 previously
Needham initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $130.00
Morgan Stanley upgraded Axsome Therapeutics from Equal-Weight to Overweight and set a new price target of $115.00 from $90.00 previously
Robert W. Baird initiated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $108.00
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4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for AXSOME THERAPEUTICS, INC.'s drug AUVELITY (ORIG-1) with active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE has changed to 'Approval' on 08/18/2022. Application Category: NDA, Application Number: 215430, Application Classification: Type 3 - New Dosage Form and Type 4 - New Combination
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Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Nov. 28, 2023 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Axsome Therapeutics, Inc. ("Axsome" or "the Company") (NASDAQ:AXSM) investors that a lawsuit filed on behalf of investors that purchased Axsome securities between May 10, 2021 and April 22, 2022, inclusive (the "Class Period") Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: [email protected], to discuss their legal rights, or click here to join the case via www.portnoylaw.com. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors' options fo
NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Susan Mahony, PhD, has been appointed to Axsome's board of directors, effective immediately. Dr. Mahony most recently served on the board of directors of Horizon Therapeutics from 2019 until its acquisition by Amgen in October 2023. She was formerly Senior Vice President of Eli Lilly and Company and President of Lilly Oncology, where under her leadership, the business unit evolved from one to five marketed medicines. At Lilly, she held leadership position
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Total 2Q 2025 net product revenue of $150.0 million, representing growth of 72% year-over-year and 24% sequentially AUVELITY® 2Q 2025 net product sales of $119.6 million, representing growth of 84% year-over-year and 24% sequentially SUNOSI® 2Q 2025 net product revenue of $30.0 million, representing growth of 35% year-over-year and 19% sequentially SYMBRAVO® launched June 10th, with 2Q 2025 net product sales of $0.4 million AUVELITY® market access expanded by 28 million new covered lives in the commercial channel First group purchasing organization (GPO) contract for SYMBRAVO® signed Supplemental NDA submission for AXS-05 in Alzheimer's disease agit
NEW YORK, July 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2025 on Monday, August 4, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts & Presentat
Total 1Q 2025 net product revenue of $121.5 million, representing 62% year-over-year growth AUVELITY® 1Q 2025 net product sales of $96.2 million, representing 80% year-over-year growth SUNOSI® 1Q 2025 net product revenue of $25.2 million, representing 17% year-over-year growth SYMBRAVO® approved for the acute treatment of migraine; commercial launch on track for June 2025 NDA for AXS-14 for the management of fibromyalgia submitted to the FDA Supplemental NDA submission for AXS-05 in Alzheimer's disease agitation on track for 3Q 2025 NDA submission for AXS-12 for cataplexy in patients with narcolepsy anticipated in 2H 2025 Positive topline results of FOCUS Phase 3 trial of solriamfetol
NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the first quarter of 2025 on Monday, May 5, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts & Presentation
Total 4Q and full year 2024 net product revenue of $118.8 million and $385.7 million, respectively, representing 66% and 88% year-over-year growth Auvelity® 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively, representing 89% and 124% year-over-year growth Sunosi® 4Q and full year 2024 net product revenue of $26.2 million and $94.3 million, respectively, representing 16% and 26% year-over-year growth Symbravo® approved in the U.S. for the acute treatment of migraine with or without aura in adults Successful completion of Phase 3 clinical program of AXS-05 in Alzh
NEW YORK, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host a virtual investor event and conference call today at 8:00 AM Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of SYMBRAVO®, a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. Experience the interactive Multimedia News Release here. During the call, Dr. Stewart Tepper, Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the New England Institute for Neurology
A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours 85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation SYMBRAVO incorporates Axsome's rapid absorption technology and mechanisms that target multiple migraine attack pathways Company to host conference call and webcast Friday, January 31, at 8:00 AM Eastern NEW YORK, Jan. 30, 2025 (GLO
NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the fourth quarter and full year of 2024 on Tuesday, February 18, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "We
ACCORD-2 Phase 3 trial in Alzheimer's disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer's disease agitation) AXS-05 reduced worsening of Alzheimer's disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer's disease overall clinical status) ADVANCE-2 trial did not demonstrate statistical significance on primary endpoint; numerically greater improvements with AXS-05 over placebo (primary and secondary endpoints) Long-term safety trial completed with required number of patients treated for 6 and 12 mo
Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth Auvelity® 3Q 2024 net product sales of $80.4 million, representing 113% year-over-year growth Sunosi® 3Q 2024 net product revenue of $24.4 million representing 21% year-over-year growth Second expansion of Auvelity psychiatry sales force planned for 1Q 2025 NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA with PDUFA goal date of January 31, 2025 Topline results of ADVANCE-2 and ACCORD-2 Phase 3 trials of AXS-05 in Alzheimer's disease agitation on track for 4Q 2024 Topline results of ENCORE Phase 3 trial of AXS-12 in narcolepsy on track for 4Q 2024 Topline results of
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