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AXSM - Earnings announcements
Axsome Therapeutics Inc. (AXSM) earnings announcements - real-time wire coverage filtered to Earnings only.
Recent Earnings for AXSM
- Axsome Therapeutics Reports First Quarter 2026 Financial Results and Provides Business UpdateTotal 1Q 2026 net product revenue of $191.2 million, representing 57% year-over-year growth AUVELITY® 1Q 2026 net product sales of $153.2 million, representing 59% year-over-year growth SUNOSI® 1Q 2026 net product revenue of $33.9 million, representing 34% year-over-year growth SYMBRAVO® 1Q 2026 net product sales of $4.1 million AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer's disease NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA AXS-20 (balipodect), potentially first-in-class, pre-Phase 3, PDE10A inhibitor for schizophrenia and Tourette syndrome, added to pipeline Company to host conference call today at 8
- Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought LeaderNEW YORK, May 01, 2026 (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 AUVELITY® (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer's disease.1 AUVELITY is a first-in-class treatment for Alzheimer's disease agitation which targets the N-methyl D-aspartate (NMDA) and sigma-1 receptors. On the call, Dr. Jeffrey Cummings, Chambers-Grundy Professor of Brain Science
- Axsome Therapeutics Announces FDA Approval of AUVELITY® (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer's DiseaseAUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to Alzheimer's disease The safety and tolerability profile of AUVELITY in agitation associated with dementia due to Alzheimer's disease has been established across short-term and long-term trials AUVELITY was developed with FDA Breakthrough Therapy designation and evaluated by the FDA under Priority Review Company to host webcast Friday, May 1, at 8:00 AM Eastern Time NEW YORK, April 30, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) di
- Axsome Therapeutics to Report First Quarter 2026 Financial Results on May 4NEW YORK, April 08, 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 first quarter of 2026 on Monday, May 4, 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 "Webcasts & Presentation
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on February 23NEW 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
- Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Third Quarter 2025 Financial Results on November 3NEW 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
- Axsome Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Second Quarter 2025 Financial Results on August 4NEW 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
- Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report First Quarter 2025 Financial Results on May 5NEW 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
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics Hosts SYMBRAVO® FDA Approval Virtual Investor Event with Expert Thought LeaderNEW 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
- Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in AdultsA 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
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results on February 18NEW 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
- Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer's Disease AgitationACCORD-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
- Axsome Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Third Quarter 2024 Financial Results on November 12NEW 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
- Axsome Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Second Quarter 2024 Financial Results on August 5NEW 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 &
- Axsome Therapeutics Reports First Quarter 2024 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report First Quarter 2024 Financial Results on May 6NEW 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
- Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in NarcolepsyAXS-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
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business UpdateTotal 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
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on February 20NEW 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
- Axsome Therapeutics Hosts Solriamfetol Virtual Investor Event with Expert Thought Leaders TodayNEW 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 trace amine-associated receptor 1 (TAAR1) agonist. At the event, invited physician thought leaders will discuss current and potential future indications. The Axsome senior leadership team will provide an overview of clinical development plans. The presenters will be availa
- Axsome Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business UpdateTotal 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 of solriamfetol in binge eating disorder on track for initiation in 4Q 2023 Phase 3 trial of solriamfetol in shift work disorder on track for initiation in 1Q 2024 NDA submission for AXS-14 in fibromyalgia and NDA resubmission for AXS-07 in migraine both expected in
- Axsome Therapeutics to Report Third Quarter 2023 Financial Results on November 6NEW 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 call at 8:00 a.m. Eastern Time on Nov. 6, 2023, 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 &
- Axsome Therapeutics to Report Second Quarter 2023 Financial Results on August 7NEW 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 conference call at 8:00 a.m. Eastern Time on Aug. 7, 2023, 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
- Axsome Therapeutics Reports First Quarter 2023 Financial Results and Corporate UpdateAuvelity® 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 management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2023. "The first quarter of 2023 was another important milestone for Axsome as it marked the first full quarter of launch for Auvelity. Based on th
- Axsome Therapeutics to Report First Quarter 2023 Financial Results on May 8NEW 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 call at 8:00 a.m. Eastern Time on May 8, 2023, 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 &
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business UpdateTotal 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 NEW YORK, Feb. 27, 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 reported financial results for the fourth qua
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results on February 27NEW 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 host a conference call at 8:00 a.m. Eastern Time on Feb. 27, 2023, 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 o
- Axsome Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business UpdateSunosi® third quarter U.S. net sales of $16.8 million Auvelity™ launched and available in U.S. pharmacies SHARP study results announced demonstrating statistically significant improvement in cognitive function with Sunosi versus placebo ADVANCE-2 trial of AXS-05 in Alzheimer's disease agitation initiated Successful Type A meeting completed for AXS-07 for the acute treatment of migraine Company to host conference call today at 8:00 AM Eastern NEW YORK, Nov. 07, 2022 (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 reported financial resu
- Axsome Therapeutics to Report Third Quarter 2022 Financial Results on November 7, 2022Axsome to host conference call and webcast on Monday, November 7, 2022 at 8:00 AM Eastern Time NEW YORK, Oct. 21, 2022 (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 2022 on Monday, November 7, 2022 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on November 7, 2022 to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405
- Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in AdultsAUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week1-4 AUVELITY uses the first new oral mechanism of action approved for major depressive disorder in over 60 years1-4 AUVELITY was developed with FDA Breakthrough Therapy designation and evaluated by the FDA under Priority Review Company to host webcast today at 8:00 AM ET NEW YORK, Aug. 19, 2022 (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 tha
- Axsome Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business UpdateCompany to host conference call today at 8:00 AM Eastern NEW YORK, Aug. 09, 2022 (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 reported financial results for the second quarter ended June 30, 2022. "We are very pleased to report our first commercial sales following the closing of the Sunosi acquisition in the second quarter. The rest of the year promises to continue to be eventful with the pending FDA action on our NDA for AXS-05 in major depressive disorder, and a Type A FDA meeting to discuss our planned resubmission of the
- Axsome Therapeutics to Report Second Quarter 2022 Financial Results on August 9, 2022Axsome to host conference call and webcast on Tuesday, August 9, 2022 at 8:00 AM Eastern Time NEW YORK, July 28, 2022 (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 2022 on Tuesday, August 9, 2022 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on August 9, 2022 to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-12
- Axsome Therapeutics Reports First Quarter 2022 Financial Results and Provides Business UpdateCompany to host conference call today at 8:00 AM Eastern NEW YORK, May 2, 2022 /PRNewswire/ -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2022. "Axsome is poised to transform into a commercial entity potentially as early as this month, a direct result of our dedicated team's focused execution. Between pending FDA action on our NDA for AXS-05 in depression and the expected closing of our acquisi
- Axsome Therapeutics to Report First Quarter 2022 Financial Results on May 2, 2022Axsome to host conference call and webcast on Monday, May 2, 2022 at 8:00 AM Eastern Time NEW YORK, April 25, 2022 /PRNewswire/ -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing 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 2022 on Monday, May 2, 2022 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on May 2, 2022 to discuss these results and provide a business update.
- Axsome Therapeutics to Acquire Sunosi® from Jazz Pharmaceuticals, Expanding Axsome's Leadership in NeuroscienceSunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved by the FDA to improve wakefulness in adults living with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea Acquisition accelerates Axsome's transformation into a global commercial entity ahead of potential near-term launches of AXS-05 in major depressive disorder (MDD) and AXS-07 in migraine Highly synergistic with Axsome's existing neuroscience portfolio and Digital Centric Commercialization™ (DCC) platform Anticipated long-lived exclusivity for Sunosi with potential for significant additional indications Immediately revenue generating, and expected to
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business UpdateCompany to host conference call today at 8:00 AM Eastern NEW YORK, March 01, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the fourth quarter and year ended December 31, 2021. "2021 was a year of continued progress which has put us in a position to potentially launch two new investigational medicines for patients living with depression and migraine," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "Specifically, FDA review of our NDA for AXS-05 in depression is progressing, and the April 30 PDUFA date f
- Axsome Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 1, 2022Axsome to host conference call and webcast on Tuesday, March 1, 2022 at 8:00 AM Eastern Time NEW YORK, Feb. 15, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its fourth quarter and fiscal year 2021 financial results on Tuesday, March 1, 2022 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on March 1, 2022 to discuss these results and provide a business update. To participate in the live conference call, please dial (844) 200-6205 (toll-free
- Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business UpdateCompany to host conference call today at 8:00 AM Eastern NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2021. "Over the past several months we have continued to advance our differentiated late-stage CNS product candidates aimed at meaningfully improving the lives of patients. FDA review of our NDA for AXS-05 in depression continues, and the NDA for AXS-07 in migraine was accepted, positioning Axsome to potentially commercialize two new treatments in the near to
- Axsome Therapeutics to Report Third Quarter 2021 Financial Results on November 8, 2021Axsome to host conference call and webcast on Monday, November 8, 2021 at 8:00 AM Eastern Time NEW YORK, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing 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 2021 on Monday, November 8, 2021 before the opening of the U.S. financial markets. Axsome's management team will host a conference call at 8:00 AM Eastern Time on November 8, 2021 to discuss these results and provide a business update. To participate in the live conference call, please dial (844) 698-4029 (toll-fr
- Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business UpdateCompany to host conference call today at 8:00 AM Eastern NEW YORK, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the second quarter ended June 30, 2021. "As part of the ongoing review of our NDA for AXS-05, the FDA recently notified us that they have identified deficiencies that preclude labeling discussions at this time. We are attempting to learn the nature of these deficiencies with the goal of addressing them, however, this development may lead to a delay in the potential approval of AXS-05. We will keep