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 |
|---|---|---|---|
| 2/24/2026 | $230.00 | Outperform | Wolfe Research |
| 1/8/2026 | $204.00 | Overweight → Equal-Weight | Morgan Stanley |
| 10/1/2025 | $179.00 | Buy | B. Riley Securities |
| 9/3/2025 | $163.00 | Overweight | Wells Fargo |
| 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 |
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Issued on behalf of Helus PharmaVANCOUVER, BC, Feb. 26, 2026 /CNW/ -- USA News Group News Commentary – The first psilocybin compound to achieve two positive Phase 3 results in treatment-resistant depression cleared that milestone this week, signaling a potential shift in how regulators and investors view psychedelic-based psychiatry[1]. The pathway is widening at the federal level, where the Drug Enforcement Administration raised its 2026 psilocybin production quota by 67%[2]. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ:HELP), Compass Pathways (NASDAQ:CMPS), Relmada Therapeutics (NASDAQ:RLMD), Alto Neuroscience (NYSE:ANRO), and Axsome
NEW YORK, Feb. 25, 2026 (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 participate in the following upcoming investor conferences in March: TD Cowen 46th Annual Health Care ConferenceFireside Chat: Monday, March 2, 2026, at 3:10 p.m. ET in Boston, MA Leerink Partners Global Healthcare ConferenceFireside Chat: Monday, March 9, 2026, at 4:20 p.m. ET in Miami Beach, FL The Citizens Life Sciences ConferenceFireside Chat: Tuesday, March 10, 2026, at 4:00 p.m. ET in Miami Beach, FL UBS Biotech Summit Miami – Catalyst for ChangeInvestor Meetings:
NEW YORK, Feb. 24, 2026 (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 the first patient has been dosed in the CLARITY Phase 3 trial of solriamfetol in the treatment of major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms. CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with MDD with EDS symptoms consisting of an open-label solriamfetol treatment period and
Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively,representing 65% and 66% year-over-year growth AUVELITY® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively,representing 68% and 74% year-over-year growth SUNOSI® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively,representing 40% and 32% year-over-year growth SYMBRAVO® 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively sNDA for AXS-05 for the treatment of Alzheimer's disease agitation granted Priority Review with PDUFAtarget action date of April 30, 2026 Acquired AXS-17, a novel
NEW YORK, Feb. 18, 2026 (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 present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Wednesday, February 25, 2026, at 2:00 p.m. ET. A live webcast of the presentation can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at axsome.com. A replay of the webcast will be available for approximately 30 days following the event. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the tr
NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem) resolving patent litigation related to Axsome's product SUNOSI® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Alkem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the se
NEW YORK, Jan. 27, 2026 (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 2025 on Monday, February 23, 2026, 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 "Webcas
NEW YORK, Jan. 15, 2026 (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 the first patient has been dosed in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia. FORWARD (Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design) is a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial in patients with fibromyalgia consisting of an open-label AXS-14 treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response d
Total preliminary 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% annual growth, respectively AUVELITY® preliminary 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively SUNOSI® preliminary 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively SYMBRAVO® preliminary 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively NEW YORK, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, to
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 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, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer's disease agitation, and has granted the application Priority Review designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. Priori
10-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
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8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
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144 - Axsome Therapeutics, Inc. (0001579428) (Subject)
144 - Axsome Therapeutics, Inc. (0001579428) (Subject)
144 - Axsome Therapeutics, Inc. (0001579428) (Subject)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
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Wolfe Research initiated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $230.00
Morgan Stanley downgraded Axsome Therapeutics from Overweight to Equal-Weight and set a new price target of $204.00
B. Riley Securities initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $179.00
Wells Fargo resumed coverage of Axsome Therapeutics with a rating of Overweight and set a new price target of $163.00
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
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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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4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
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Live Leadership Updates
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 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively,representing 65% and 66% year-over-year growth AUVELITY® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively,representing 68% and 74% year-over-year growth SUNOSI® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively,representing 40% and 32% year-over-year growth SYMBRAVO® 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively sNDA for AXS-05 for the treatment of Alzheimer's disease agitation granted Priority Review with PDUFAtarget action date of April 30, 2026 Acquired AXS-17, a novel
NEW YORK, Jan. 27, 2026 (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 2025 on Monday, February 23, 2026, 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 "Webcas
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 net product sales of $2.1 million sNDA for AXS-05 in Alzheimer's disease agitation submitted to the FDA Company to host conference call today at 8:00 AM Eastern NEW YORK, Nov. 03, 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 financial results for the t
NEW YORK, Oct. 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 it will report its financial results for the third quarter of 2025 on Monday, November 3, 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 & Presenta
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