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Axsome Therapeutics, Inc. (AXSM) Create: Alert

All | News | Filings
Date FiledTypeDescription
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..."
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..."
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..."
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..."
05/02/2022 8-K Quarterly results
Docs: "Axsome Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern NEW YORK, May 2, 2022 /PRNewswire/ – Axsome Therapeutics, Inc. , a biopharmaceutical company developing novel therapies for the management of central nervous system 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 acquisition of Sunosi, Axsome is well-positioned to potentially make two important new medicines available to patients living with serious CNS ...",
"Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support approval Company plans to engage with FDA toward expeditious resolution of outstanding items NEW YORK, May 2, 2022 /PRNewswire/ – Axsome Therapeutics, Inc. , a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, today announced that the Company has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in th..."
03/01/2022 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern NEW YORK, March 01, 2022 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing novel therapies for the management of central nervous system 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 for our NDA ..."
11/08/2021 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern NEW YORK, November 8, 2021 – Axsome Therapeutics, Inc. , a biopharmaceutical company developing novel therapies for the management of central nervous system 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 intermediate term for patients living..."
08/09/2021 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern",
"Axsome Therapeutics Announces AXS-05 Achieves Primary and Key Secondary Endpoints in the MERIT Phase 2 Trial in Treatment Resistant Depression AXS-05 significantly delayed the time to relapse of depression compared to placebo"
05/10/2021 8-K Quarterly results
Docs: "Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Company to host conference call today at 8:00 AM Eastern"
03/01/2021 8-K Quarterly results
11/05/2020 8-K Quarterly results
Docs: "Press Release"
08/10/2020 8-K Quarterly results
05/08/2020 8-K Quarterly results
Docs: "Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company",
"First Quarter 2020 Financial Results Presentation"
03/12/2020 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update NDA filing for Breakthrough Therapy designated AXS-05 in MDD expected in 4Q 2020 NDA filing for AXS-07 in migraine expected in 4Q 2020"
11/07/2019 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD completed enrollment and on track for readout of topline results by year-end 2019"
08/08/2019 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update Both STRIDE-1 Phase 3 trial in TRD and GEMINI Phase 3 trial in MDD for AXS-05 on track for readout of topline results in 2H 2019"
05/09/2019 8-K Quarterly results
Docs: "Axsome Therapeutics Reports First Quarter 2019 Financial Results and Provides Business Update"
03/14/2019 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update",
"Corporate Presentation"
11/09/2018 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Third Quarter 2018 Financial Results and Provides Business Update"
08/08/2018 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update"
05/08/2018 8-K Quarterly results
Docs: "Axsome Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update"
03/07/2018 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update",
"Corporate Presentation"
11/08/2017 8-K Quarterly results
Docs: "Axsome Therapeutics Reports Third Quarter 2017 Financial Results NEW YORK, Nov. 08, 2017 — Axsome Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, today reported financial results for the quarter ended September 30, 2017. “In the third quarter we launched our Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer's disease agitation and reported positive Phase 1 trial results with our new clinical-stage product candidate, AXS-06,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “We are very excited to be advancing a broad portfolio of differentiated product candidates for important clinical indications. Specifically, we are nearing the interim efficacy results of the CREATE-1 trial o..."
08/09/2017 8-K Quarterly results
05/09/2017 8-K Quarterly results
03/07/2017 8-K Quarterly results
11/14/2016 8-K Quarterly results
05/11/2016 8-K Quarterly results
03/29/2016 8-K Quarterly results

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