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 |
|---|---|---|---|
| 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 |
| 12/13/2023 | $125.00 | Buy | Citigroup |
| 8/8/2023 | $59.00 → $81.00 | Underperform → Neutral | BofA Securities |
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
NEW YORK, July 11, 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, today announced it will report its financial results for the second quarter of 2024 on Monday, August 5, 2024, before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 a.m. Eastern Time on August 5, 2024, to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). A live webcast of the conference call can be accessed on the "Webcasts &
Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth Auvelity® 1Q 2024 net product sales of $53.4 million, representing 240% year-over-year growth Sunosi® 1Q 2024 net product revenue of $21.6 million representing 64% year-over-year growth Contract executed with second large group purchasing organization (GPO) for potential coverage of Auvelity Positive pivotal Phase 3 trial results of AXS-12 in narcolepsy announced Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation and FOCUS Phase 3 trial of solriamfetol in ADHD both anticipated 2H 2024 ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's diseas
NEW YORK, April 10, 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, today announced it will report its financial results for the first quarter of 2024 on Monday, May 6, 2024, before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 a.m. Eastern Time on May 6, 2024, to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). A live webcast of the conference call can be accessed on the "Webcasts & Prese
AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint) AXS-12 achieved statistically significant remission of cataplexy compared to placebo (p=0.008) AXS-12 statistically significantly reduced excessive daytime sleepiness (EDS) severity compared to placebo (p=0.027, CGI-S for EDS) AXS-12 statistically significantly improved concentration and memory compared to placebo (p=0.004, Cognitive Function items of FOSQ-10) AXS-12 statistically significantly reduced overall severity of narcolepsy compared to placebo (p=0.007, CGI-S for narcolepsy) AXS-12 statistically significantly improved overall function and quality of life compared to pla
Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing year-over-year growth of 193% and 309% Auvelity 4Q and full year 2023 net product sales of $49.0 million and $130.1 million, respectively, during the first full year of launch Sunosi 4Q and full year 2023 net product revenue of $22.5 million and $74.8 million, respectively, representing 17% and 67% year-over-year growth NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine, both anticipated in 1H 2024 Topline results of the SYMPHONY Phase 3 trial in narcolepsy anticipated in 1Q 2024 Topline results of the ADVANCE-2 Phase 3 trial in Alzheimer's d
NEW YORK, Jan. 23, 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, today announced it will report its financial results for the fourth quarter and full year of 2023 on Tuesday, Feb. 20, 2024, before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 a.m. Eastern Time on Feb. 20, 2024, to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). A live webcast of the conference call can be accessed on th
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SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
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SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
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
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
10-Q - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
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8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
S-8 - Axsome Therapeutics, Inc. (0001579428) (Filer)
10-Q - Axsome Therapeutics, Inc. (0001579428) (Filer)
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
Citigroup initiated coverage of Axsome Therapeutics with a rating of Buy and set a new price target of $125.00
BofA Securities upgraded Axsome Therapeutics from Underperform to Neutral and set a new price target of $81.00 from $59.00 previously
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
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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)
Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 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 preliminary net product revenue for the fourth quarter and full year ended December 31, 2024. "We delivered strong revenue growth in 2024 and significantly advanced our industry leading neuroscience pipeline, including achievement of positive Phase 3 results for AXS-
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
AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint) Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ) Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C) Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of patients at 1 month and 78% at 6 months Improvement in narcolepsy overall, assessed by the CGI-C, achieved by 90% of patients at 1 month and 90% at 6 months Well-tolerated with long-term safety
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, Nov. 08, 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, today announced eight presentations spanning its innovative portfolio of late-stage products and product candidates in psychiatry and neurology at NEI Congress 2024, being held Nov. 7 - Nov. 10, 2024, in Colorado Springs, Colorado. Details for the presentations are as follows: Major Depressive Disorder Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)Presentation Date and Time: Friday, Nov. 8, 3:35 –
NEW YORK, Oct. 29, 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, today announced seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts. Details for the presentations are as follows: Major Depressive Disorder Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday
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
NEW YORK, Sept. 24, 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, today announced seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, being held September 24-27, 2024, in Seville, Spain. Featured presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey underscoring the unmet needs of patients with type 1 narcolepsy, and previously reported data on solriamfetol demonstrating improvement in cognitive
NEW YORK, Sept. 04, 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, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025. About Migraine Migraine is a serious neurological condition characterized by recurrent attacks of pulsating, often severe and disablin
Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York Wells Fargo Healthcare Conference on September 5 in Boston Baird 2024 Global Healthcare Conference on September 11 in New York Cantor Global Healthcare Conference on September 18 in New York NEW YORK, Aug. 27, 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 participate in four investor conferences in September: Morgan Stanley 22nd Annual Global Healthcare ConferenceThe Company will present on Wednesday, September 4, 2024 at 4:50 p.m. ET in N
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