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Axsome Therapeutics, Inc. (AXSM)
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Create: Alert |
All | News | Filings
Date Filed | Type | Description |
10/11/2023 |
8-K
| Quarterly results |
08/15/2023 |
8-K
| Other Events, Financial Statements and Exhibits Interactive Data |
08/07/2023 |
8-K
| Quarterly results |
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:
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"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..." |
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06/30/2023 |
8-K
| Other Events, Financial Statements and Exhibits Interactive Data
Docs:
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"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..." |
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06/08/2023 |
8-K
| Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements... |
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 |
02/22/2023 |
8-K
| Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits Interactive Data |
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 |
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:
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"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..." |
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09/01/2022 |
8-K
| Other Events, Financial Statements and Exhibits Interactive Data |
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 |
08/19/2022 |
8-K
| Other Events, Financial Statements and Exhibits Interactive Data |
08/09/2022 |
8-K
| Quarterly results |
07/21/2022 |
8-K/A
| Financial Statements and Exhibits Interactive Data
Docs:
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"Consent of Independent Auditor We consent to the incorporation by reference in the registration statements on Form S-3 and Form S-8 of Axsome Therapeutics, Inc. of our report dated May 3, 2022 with respect to the abbreviated financial statements of the Sunosi product of Jazz Pharmaceuticals plc, which report appears in the Form 8-K/A of Axsome Therapeutics, Inc. filed July 21, 2022. /s/ KPMG Dublin, Ireland July 21, 2022",
"SUNOSI® Abbreviated Financial Statements As of and for the Years Ended December 31, 2021 and 2020 Index to Abbreviated Financial Statements Page Independent Auditors’ Report 2 Abbreviated Financial Statements: Statements of Assets Acquired 4 Statements of Revenues and Direct Expenses 5 Notes to Abbreviated Financial Statements 6 INDEPENDENT AUDITORS’ REPORT The Board of Directors Jazz Pharmaceuticals plc: REPORT ON ABBREVIATED FINANCIAL STATEMENTS OF THE SUNOSI PRODUCT OF JAZZ PHARMACEUTICALS PLC Opinion We have audited the abbreviated financial statements of the Sunosi product of Jazz Pharmaceuticals plc , which comprise the statement of assets acquired as of December 31, 2021 and 2020, and the related statement of revenues and direct expenses for each of the years then ended, and the re...",
"Index to Unaudited Abbreviated Financial Statements Page Unaudited Abbreviated Financial Statements: Statements of Assets Acquired 2 Statements of Revenues and Direct Expenses 3 Notes to Unaudited Abbreviated Financial Statements 4 Sunosi® Statements of Assets Acquired March 31, 2022 December 31, 2021 Assets Acquired Intangible assets, net $ 72,279 $ 74,243 Inventories, net 21,163 21,557 Other current assets 378 412 Total assets acquired $ 93,820 $ 96,212 The accompanying notes are an integral part of these unaudited abbreviated financial statements. 2 Sunosi® Statements of Revenues and Direct Expenses Three Months Ended March 31, 2022 2021 Product sales, net $ 15,878 $ 11,606 Direct expenses: Cost of product sales 4,178 2,074 Selling, general and administrative 35,288 66,347 Research ...",
"UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS On March 25, 2022, Axsome Therapeutics, Inc. entered into an Asset Purchase Agreement with Jazz Pharmaceuticals plc, pursuant to which the Company will acquire Sunosi from Jazz Pharmaceuticals . The acquisition of Sunosi will occur in two separate closings. The sale and purchase of Specified Initial Assets as defined and contemplated by the Purchase Agreement occurred on May 9, 2022 , following the satisfaction or waiver of the closing conditions under the Purchase Agreement. The sale and purchase of Specified Ex-U.S. Assets contemplated by the Purchase Agreement is expected to occur during the fourth quarter of 2022 . The following unaudited pro forma condensed combined financial statements of Axsome and Sunosi present the combin..." |
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06/28/2022 |
8-K
| Other Events, Financial Statements and Exhibits Interactive Data |
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 |
06/01/2022 |
8-K
| Other Events Interactive Data
Docs:
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"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..." |
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05/31/2022 |
8-K
| Other Events Interactive Data
Docs:
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"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..." |
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05/18/2022 |
8-K
| Other Events Interactive Data
Docs:
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"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..." |
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