NEW YORK, Aug. 27, 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 the following upcoming investor conferences in September: 2025 Wells Fargo Healthcare Conference Fireside Chat: Wednesday, September 3, 2025, at 3:45 p.m. ET in Boston, MA Cantor Global... Read More

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 10 th , with 2Q 2025 net product sales of $0.4... Read More

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... Read More

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,... Read More

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... Read More

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... Read More

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... Read More

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 67 th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in... Read More

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... Read More

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... Read More

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... Read More

NEW YORK, June 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 has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia. The FDA states that upon... Read More

NEW YORK, May 29, 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 three upcoming investor conferences in June: William Blair 45 th Annual Growth Stock Conference The Company will present on Tuesday, June 3, 2025, at 10:40 a.m. CT in Chicago, IL Jefferies... Read More

NEW YORK, May 28, 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 presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona. Details of the... Read More

NEW YORK, May 27, 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 Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI ® (solriamfetol). The litigation, which... Read More

Previous term loan facility retired NEW YORK, May 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 that it has entered into a $570 million term loan and revolving credit facility with funds managed by Blackstone Life Sciences and Blackstone Credit & Insurance (“Blackstone”).... Read More

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... Read More

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... Read More

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 Conference The Company will present on Wednesday, May 7, 2025, at 1:30 p.m. ET in New York, NY BofA Securities 2025... Read More

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... Read More

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... Read More

Results support continued development in MDD with concomitant EDS; Phase 3 trial planned in 2025 Approximately 50 percent of MDD patients experience EDS 1 , 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... Read More

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... Read More

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... Read More

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.... Read More

TD Cowen 45 th 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 45 th... Read More

SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint) 2-hour pain freedom for most attacks reported at least half the time by 47.9% of patients after SYMBRAVO versus 1.0% after oral CGRPs (p<0.001) 24-hour or greater sustained pain relief after a single dose reported by 47.9% of patients... Read More

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%... Read More

NEW YORK, Feb. 10, 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 Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome’s AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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,... Read More

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.... Read More

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... Read More

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... Read More

Morgan Stanley 22 nd 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... Read More

NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has reached agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome’s product Sunosi ® (solriamfetol). The litigation, which was pending in the United States... Read More

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... Read More

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... Read More

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome’s product Sunosi ® (solriamfetol). The litigation, which... Read More

NEW YORK, June 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, announced today it is joining the migraine advocacy community to raise awareness of unmet patient needs during Migraine & Headache Awareness Month this June. “Education plays a crucial role in addressing the... Read More

NEW YORK, June 03, 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, announced today it is supporting Alzheimer’s & Brain Awareness Month this June, to help increase awareness and understanding of the challenges Alzheimer’s disease (AD) presents to patients, their caregivers,... Read More

NEW YORK, May 30, 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 Axsome will participate in two upcoming investor conferences. The conference details are as follows: William Blair 44th Annual Growth Stock Conference, on Wednesday, June 5, at 2 p.m.... Read More

NEW YORK, May 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 five presentations, including two featured oral plenary presentations, on solriamfetol at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep... Read More

NEW YORK, May 28, 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 data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held... Read More

NEW YORK, May 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 that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences. The presentation details are as follows: RBC Capital Markets 2024 Global... Read More

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... Read More

NEW YORK, May 01, 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 is joining the global community of mental health advocates, including Mental Health America, during May’s Mental Health Month to raise awareness of the importance of mental health as a key element of... Read More

AXS-05 in Alzheimer’s disease agitation data featured in oral plenary session New data for AXS-07 in migraine demonstrating efficacy in pooled analysis Presentations on cognitive and wake promoting effects of solriamfetol NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system... Read More

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... Read More

NEW YORK, April 01, 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, announced the initiation of the ENGAGE Phase 3 trial of solriamfetol, an investigational treatment for binge eating disorder (BED) in adults. ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge... Read More

77% of narcolepsy type 1 patients continue to experience cataplexy attacks despite being treated 64% of narcolepsy type 1 patients continue to experience excessive daytime sleepiness, as assessed by the Epworth Sleepiness Scale (ESS), despite being treated 74% of treated narcolepsy type 1 patients exhibit cognitive impairment, as assessed by the British Columbia Cognitive Complaints Inventory (BC-CCI) Depression and anxiety... Read More

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... Read More

NEW YORK, March 19, 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 the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD). PARADIGM (Progressing TAAR-1, Dopamine, and... Read More

NEW YORK, March 05, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Leerink Partners Global Biopharma Conference on Wednesday, March 13, at 9:20 a.m. Eastern... Read More

NEW YORK, Feb. 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, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the TD Cowen 44th Annual Healthcare Conference on Wednesday, March 6, from 9:50-10:20 a.m.... Read More

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... Read More

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... Read More

Preliminary total 4Q and full year 2023 net product revenue of $71 million and $204 million, respectively Auvelity preliminary 4Q and full year 2023 net product sales of $49 million and $130 million, respectively Sunosi preliminary 4Q and full year 2023 net product revenue of $22 million and $74 million, respectively 2024 anticipated regulatory milestones include NDA submission for AXS-14 in fibromyalgia and NDA resubmission... Read More

New data on Auvelity’s impact on quality of life, measured by the Q-LES-Q-SF, in patients who had received at least one prior treatment during their current depressive episode Data on Auvelity exploring reduction of depressive symptoms regardless of a patient’s interest-activity symptom severity NEW YORK, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and... Read More

NEW YORK, Dec. 07, 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, is hosting a virtual investor event and conference call today from 8 a.m. – 10 a.m. Eastern Time to provide an update on solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) and... Read More

NEW YORK, Nov. 22, 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 it will host a virtual event on December 7 from 8 a.m. - 10 a.m. Eastern Time to provide investors an update on its development programs for solriamfetol, a dual-acting dopamine and... Read More

NEW YORK, Nov. 21, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, Nov. 28, 2023, from 9:30 a.m.... Read More

Total 3Q 2023 product revenue of $57.8 million, representing 244% year-over-year growth Auvelity ® 3Q 2023 net product sales of $37.7 million, representing 36% quarter-over-quarter growth Sunosi ® 3Q 2023 net product revenue of $20.1 million, representing 20% year-over-year growth SYMPHONY Phase 3 trial of AXS-12 in narcolepsy on track for completion of enrollment in 4Q 2023; topline results expected in 1Q 2024 Phase 3 trial... Read More

NEW YORK, Nov. 02, 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 it is joining advocacy organizations around the world to help raise awareness of Alzheimer’s disease (AD) and to stand in solidarity with all those affected by this condition and their families... Read More

NEW YORK, Oct. 31, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences in early November. The presentation details are as follows: Guggenheim... Read More

NEW YORK, Oct. 24, 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 a presentation of data from its ACCORD Phase 3 clinical trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, in patients with Alzheimer’s disease agitation... Read More

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... Read More

NEW YORK, Oct. 10, 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 it will report its financial results for the third quarter of 2023 on Monday, Nov. 6, 2023, before the opening of the U.S. financial markets. Axsome’s management team will host a conference... Read More

NEW YORK, Oct. 02, 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 it is joining patient advocacy organizations, including the National Alliance on Mental Illness (NAMI), to promote awareness of the importance of mental health during Mental Illness Awareness... Read More

NEW YORK, Sept. 21, 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 it is joining the global narcolepsy advocacy community, including more than 20 global patient advocacy organizations across six continents, to raise awareness of the impact that narcolepsy has... Read More

Data presentations explore effects on patient-centric efficacy measures of treatments for patients with depression, and excessive sleepiness associated with obstructive sleep apnea and narcolepsy NEW YORK, Sept. 07, 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... Read More

NEW YORK, Sept. 05, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in three upcoming investor conferences in September. The presentation details are as follows: H.C. Wainwright 25th... Read More

Total 2Q 2023 product revenue of $46.7 million Auvelity ® 2Q 2023 net product sales of $27.6 million, representing 76% quarter-over-quarter growth Sunosi ® 2Q 2023 net product revenue of $19.1 million Pro forma second quarter cash balance of $468.8 million FOCUS Phase 3 trial of solriamfetol in attention-deficit hyperactivity disorder initiated Positive FDA pre-IND meeting feedback received for two new potential indications... Read More

NEW YORK, July 12, 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 it will report its financial results for the second quarter of 2023 on Monday, Aug. 7, 2023, before the opening of the U.S. financial markets. Axsome’s management team will host a... Read More

NEW YORK, July 07, 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 it has dosed the first patient in the FOCUS Phase 3 trial of solriamfetol, an investigational treatment for attention deficit hyperactivity disorder (ADHD) in adults. FOCUS (Forward... Read More

NEW YORK, June 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the closing of its previously announced underwritten public offering of 3,000,000 shares of its common stock at the public offering price of $75.00 per share. The... Read More

NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $75.00 per share. The proceeds from the offering,... Read More

NEW YORK, June 27, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. In addition, Axsome intends to grant the... Read More

NEW YORK, June 01, 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 presentations on Sunosi ® (solriamfetol) at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, being held in Indianapolis, Ind., from June... Read More

Data on Auvelity demonstrating improved functioning in major depressive disorder Data on Sunosi demonstrating improved cognitive function in patients with excessive daytime sleepiness associated with obstructive sleep apnea NEW YORK, May 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system... Read More

Auvelity ® 1Q 2023 net product sales of $15.7 million Total 1Q 2023 net product sales of $28.6 million Total 1Q 2023 revenue of $94.6 million, including Sunosi ® ex-U.S. license agreement upfront payment Company to host conference call today at 8:00 AM Eastern NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the... Read More

NEW YORK, May 03, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Bank of America Securities 2023 Healthcare Conference being held in Las Vegas, Nevada on... Read More

NEW YORK, May 01, 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, is joining Mental Health America (MHA) and the State of New York to raise awareness of mental health during May is Mental Health Month. In observance of the beginning of May is Mental Health Month, Axsome’s new... Read More

NEW YORK, April 21, 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 it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston. These presentations include new data... Read More

NEW YORK, April 14, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on Thursday, April 20, 2023, at 1:30... Read More

NEW YORK, April 13, 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 it will report its financial results for the first quarter of 2023 on Monday, May 8, 2023, before the opening of the U.S. financial markets. Axsome’s management team will host a conference... Read More

NEW YORK, March 01, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at Cowen’s 43rd Annual Health Care Conference on Wednesday, March 8, 2023, at 2:10 p.m. Eastern... Read More

Total fourth quarter net product sales of $24.4 million Auvelity ® launched October 19th, with fourth quarter net product sales of $5.2 million Sunosi ® fourth quarter net product sales of $19.2 million Sunosi ® license agreement for EU announced – $66 million upfront, potential milestones up to $101 million Pro forma fourth quarter net cash in excess of $300 million Company to host conference call today at 8:00 AM Eastern... Read More

Axsome to receive an upfront payment of $66 million, and is eligible to receive sales-based and other milestones totaling up to $101 million Pharmanovia is responsible for all ongoing and future clinical studies in Europe and MENA NEW YORK, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous... Read More

NEW YORK, Feb. 07, 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 Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the SVB Securities Global Biopharma Conference on Wednesday, Feb. 15, 2023, at 8:40 a.m.... Read More

NEW YORK, Jan. 31, 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 it will report its financial results for the fourth quarter and full year of 2022 on Monday, Feb. 27, 2023, before the opening of the U.S. financial markets. Axsome’s management team will... Read More

Improvement in cognitive and physical functioning, measured by the CPFQ patient-rated scale, starting at week 1 and sustained over 12 months Improvement in disability, measured by the SDS, starting at week 1 and sustained over 12 months NEW YORK, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central... Read More