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Axsome Therapeutics, Inc. (AXSM) Create: Alert

All | News | Filings
Date FiledTypeDescription
10/11/2023 8-K Quarterly results
08/15/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "17 M 34 M 185 K 4 M 37 M 5 M ADHD"
08/07/2023 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update 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 for solriamfetol: Phase 3 trial initiations planned for binge eating disorder in 4Q 2023, and shift work disorder in 1Q 2024 Company to host conference call today at 8:00 AM Eastern NEW YORK, August 7, 2023 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing an..."
08/04/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
07/07/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of Attention Deficit Hyperactivity Disorder in Adults NEW YORK, July 7, 2023 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system 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 in adults. FOCUS is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults. Approximately 450 patients will be randomized in a 1:1:1 ratio to receive solriamfetol or placebo for 6 weeks. The primary endpoint..."
06/30/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Announces Closing of Public Offering of $225 Million of Shares of Common Stock NEW YORK, June 30, 2023 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system 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 aggregate gross proceeds to Axsome, before deducting underwriting discounts and commissions and offering expenses, were $225.0 million. Axsome intends to use the proceeds from this offering to advance its late-stage pipeline, including funding existing and potential new clinical programs, products, and product candidates, to expand its com..."
06/08/2023 8-K Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements...
Docs: "2023 Employee Stock Purchase Plan of Axsome Therapeutics, Inc. 1. Establishment. The Employee Stock Purchase Plan of Axsome Therapeutics, Inc. is hereby established effective as of the Effective Date. 2. Purpose. This Plan is intended to provide employees of the Company and its Participating Subsidiaries with an opportunity to acquire a proprietary interest in the Company through the purchase of shares of Common Stock. The Company intends that the Plan qualify as an “employee stock purchase plan” under Section 423 of the Code and the Plan shall be interpreted in a manner that is consistent with that intent. 3. Definitions. “Board or Board of Directors” means the Board of Directors of the Company, as constituted from time to time. “Business Day” mea..."
05/08/2023 8-K Quarterly results
03/13/2023 8-K Regulation FD Disclosure, Financial Statements and Exhibits  Interactive Data
03/10/2023 8-K Regulation FD Disclosure, Financial Statements and Exhibits  Interactive Data
02/27/2023 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update 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 NEW YORK, February 27, 2023 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today reported financial results for the fourth quarter and full year ended Decemb..."
02/22/2023 8-K Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Enters into License Agreement with Pharmanovia to Expand Commercialization and Further Develop Sunosi® in Europe 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 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into an exclusive license agreement with Pharmanovia to commercialize and further develop Sunosi® , the first and only dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults liv..."
02/13/2023 8-K Quarterly results
01/09/2023 8-K Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits  Interactive Data
11/28/2022 8-K Quarterly results
11/14/2022 8-K Quarterly results
11/07/2022 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update Sunosi® 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, November 7, 2022 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today reported financial results for the third quarter ended September 30, 2..."
10/20/2022 8-K Quarterly results
10/03/2022 8-K Quarterly results
09/29/2022 8-K Quarterly results
09/08/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Initiates ADVANCE-2 Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation NEW YORK, Sept. 08, 2022 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, announced that it has enrolled the first patient in the ADVANCE-2 trial of AXS-05, an investigational treatment for Alzheimer’s disease agitation. ADVANCE-2 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, trial to assess the efficacy and safety of AXS-05 for the treatment of agitation associated with AD. Approximately 350 patients will be randomized in a 1:1 ratio to receive AXS-05 or placebo for 5 weeks. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory . AXS-05 has be..."
09/01/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Initiates EMERGE Phase 3 Open-Label Trial of AXS-07 for the Acute Treatment of Migraine in Adults with a Prior Inadequate Response to an Oral CGRP Inhibitor NEW YORK, September 1, 2022 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, announced that it has enrolled the first patient in the EMERGE trial of AXS-07 for the acute treatment of migraine. EMERGE is a Phase 3, open-label, multicenter trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine in patients with a prior inadequate response to an oral Calcitonin Gene-Related Peptide inhibitor. Approximately 100 patients experiencing migraine attacks will be treated with AXS-07 for up to..."
08/23/2022 8-K Results of Operations and Financial Condition, Other Events  Interactive Data
08/19/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Opinion of DLA Piper LLP (US)"
08/19/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549",
"Axsome Therapeutics Announces FDA Approval of AUVELITY TM , the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults"
08/09/2022 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern NEW YORK, August 9, 2022 -- Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system 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 NDA for AXS-07 in migraine, both anticipated thi..."
06/28/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "2019 2020 2021 Q1 2022 US"
06/27/2022 8-K Other Events  Interactive Data
06/07/2022 8-K Submission of Matters to a Vote of Security Holders, Financial Statements and Exhibits  Interactive Data
06/02/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder AXS-05 rapidly and significantly improved anhedonic symptoms, measured by the MADRS anhedonia subscale, starting 1 week after treatment Data being presented at the American Society of Clinical Psychopharmacology 2022 Annual Meeting NEW YORK, June 2, 2022 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that treatment with AXS-05 rapidly and significantly reduced anhedonic symptoms in the GEMINI Phase 3 trial in major depressive disorder . These new data are being presented today at the American Society of Clinical Psychoph..."
06/01/2022 8-K Other Events  Interactive Data
Docs: "Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology 2022 Annual Meeting Rapid, substantial, and durable improvement in depressive symptoms , and functioning with AXS-05, sustained over 12 months, with AXS-05, sustained over 12 months, – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced positive results from the long-term, open-label EVOLVE trial of AXS-05 in major depressive disorder . EVOLVE assessed the long-term efficacy and safety of AXS-05 in patients failing one or more prior antidepressants during..."
05/31/2022 8-K Other Events  Interactive Data
Docs: "Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry AXS-05 demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared to placebo starting 1 week after treatment NEW YORK, May 31, 2022 /PRNewswire/ – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced the publication on May 30, 2022 of the results from the pivotal GEMINI Phase 3 clinical trial of AXS-05 in major depressive disorder . AXS-05 is a novel, oral, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity. The article, “Efficacy and Safety of AXS-05 i..."
05/18/2022 8-K Other Events  Interactive Data
Docs: "Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry In this study, AXS-05 demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared with the active comparator bupropion NEW YORK, May 18, 2022 /PRNewswire/ – Axsome Therapeutics, Inc. , a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced the publication of the results from the pivotal ASCEND Phase 2 clinical trial of AXS-05 in major depressive disorder . AXS-05 is a novel, oral, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity. The article, “Effect of AXS-05 in Major Depressive D..."
05/09/2022 8-K Completion of Acquisition or Disposition of Assets, Creation of a Direct Financial Obligation or an Obligation under an Off-B...
Docs: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549",
"Axsome Therapeutics Completes U.S. Acquisition of Sunosi ® for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea"
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