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 |
|---|---|---|---|
| 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 |
| 2/6/2024 | $111.00 | Buy | UBS |
| 1/25/2024 | $126.00 | Outperform | RBC Capital Mkts |
10-Q - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
DEFA14A - Axsome Therapeutics, Inc. (0001579428) (Filer)
DEF 14A - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
10-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
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
UBS initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $111.00
RBC Capital Mkts initiated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $126.00
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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SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
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, May 01, 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 is joining with Mental Health America (MHA) and the broader mental health advocacy community in a consolidated effort to raise awareness and promote action during May's Mental Health Month. On May 1, as part of Mental Health America's "Light Up Green" initiative, Axsome's New York City headquarters, the One World Trade Center building, will be lit in green, the color for mental health awareness, and through the building's Spireworks program. "Mental Health America's 2024 data co
NEW YORK, April 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 that it will participate in four upcoming investor conferences in May: The Citizens 2025 Life Sciences ConferenceThe Company will present on Wednesday, May 7, 2025, at 1:30 p.m. ET in New York, NY BofA Securities 2025 Health Care ConferenceThe Company will present on Tuesday, May 13, 2025, at 3:00 p.m. PT in Las Vegas, NV 2025 RBC Capital Markets Global Healthcare ConferenceThe Company will present on Tuesday, May 20, 2025, at 3:05 p.m. ET in New York, NY Mizuho Neu
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
Late-breaking oral presentation of results from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation Presentation featuring network meta-analysis of SYMBRAVO® versus oral CGRPs NEW YORK, April 04, 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 multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California. Oral and poster presentations include data from the positive pivo
Results support continued development in MDD with concomitant EDS; Phase 3 trial planned in 2025 Approximately 50 percent of MDD patients experience EDS1, highlighting high unmet need NEW YORK, April 01, 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 results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS). In the overall patient population, the study did not demonstrate a statistically significant change on the Montgomery-Åsberg Depression Ra
Demonstrated substantial and statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, primary endpoint, 150 mg solriamfetol) Statistically significant reduction in overall ADHD disease severity as measured by the CGI-S score compared to placebo (p=0.017, key secondary endpoint, 150 mg solriamfetol) Statistically significant rate of clinical response on the AISRS compared to placebo (p=0.024, 150 mg solriamfetol) Onset of action as early as Week 1 compared to placebo (p=0.036, AISRS, 150 mg solriamfetol) Well tolerated with safety profile generally consistent with prior solriamfetol trials NEW YORK, March 25, 2025 (GLOBE
NEW YORK, March 05, 2025 (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 Hikma Pharmaceuticals USA, Inc. (Hikma) 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 Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the ter
NEW YORK, March 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 that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer's disease agitation. AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company's planned sND
TD Cowen 45th Annual Health Care Conference on March 4 in Boston Leerink Partners Global Biopharma Conference on March 12 in Miami NEW YORK, Feb. 26, 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 participate in two upcoming investor conferences in March: TD Cowen 45th Annual Health Care ConferenceThe Company will present on Tuesday, March 4, 2025, at 9:50 a.m. ET in Boston, MA Leerink Partners Global Biopharma ConferenceThe Company will present on Wednesday, March 12, 2025, at 10:40 a.m. ET in Miami, FL Live webcasts of the presenta
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
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
NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, will report its financial results for the third quarter of 2024 on Tuesday, November 12, 2024, 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
Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth Auvelity® 2Q 2024 net product sales of $65.0 million, representing 135% year-over-year growth Sunosi® 2Q 2024 net product revenue of $22.1 million representing 16% year-over-year growth NDA for AXS-07 in migraine resubmitted Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation anticipated 2H 2024 Topline results of ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation anticipated 2H 2024; target enrollment reached Topline results of FOCUS Phase 3 trial of solriamfetol in ADHD anticipated 2H 2024 SUSTAIN Phase 3 trial of solriamf
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)