AXSOME THERAPEUT. DL-0001 WKN: A2AA7B ISIN: US05464T1043 Kürzel: AXSM Forum: Aktien Thema: Hauptdiskussion

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Zeit das es wieder nach oben geht, die letzten Tage wahren hart

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Axsome says it remains on track to submit AXS-05 marketing application to the FDA https://newsfilter.io/a/361877da089094d55c8cd738862b69e1 • Axsome Therapeutics (AXSM +0.1%) announces that it remains on track and is in the process of submitting a New Drug Application for AXS-05 in major depressive disorder to the U.S. FDA. • Axsome initiated its ACCORD study, a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer’s disease agitation, in December last year. • AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. • The company had also announced positive results from the open-label Phase 2 COMET-SI trial of AXS-05 in patients with major depressive disorder who have suicidal ideation, last month

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Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine https://www.globenewswire.com/news-release/2020/12/31/2152004/0/en/Axsome-Therapeutics-Announces-Positive-Efficacy-and-Safety-Results-from-the-Phase-3-MOVEMENT-Long-Term-Trial-of-AXS-07-in-the-Acute-Treatment-of-Migraine.html Over 21,000 migraine attacks treated with AXS-07 Achieved migraine pain relief in approximately 70% of patients, and pain freedom in approximately 40% of patients, at 2 hours Achieved durable relief, with approximately 85% of patients free from rescue medication use over 48 hours Long-term safety profile consistent with previously completed controlled trials NDA on track for submission in 1Q 2021

Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer's Disease Agitation https://www.benzinga.com/node/18975732 ACCORD is the second pivotal trial of AXS-05 in Alzheimer's disease agitation No treatments are currently approved for Alzheimer's disease agitation

Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation https://www.globenewswire.com/news-release/2020/12/08/2141143/0/en/Axsome-Therapeutics-Announces-Positive-Results-from-the-COMET-SI-Trial-of-AXS-05-in-Patients-with-Major-Depressive-Disorder-Who-Have-Suicidal-Ideation.html 68% reduction in MADRS Suicidality Item score by Week 1, and 82% reduction by Week 4 Resolution of suicidal ideation achieved by 60% of patients by Week 1, and 78% by Week 4 Effects consistent with new integrated data from AXS-05 controlled trials demonstrating reduction in MADRS Suicidality Item score versus control, at Week 1 (p=0.001) Rapid and substantial improvement in functioning achieved by 51% of patients at Week 1 and 77% of patients at Week 6 (Sheehan Disability Scale) ...

https://www.marketbeat.com/instant-alerts/nasdaq-axsm-a-buy-or-sell-right-now-2020-12/

Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression https://www.globenewswire.com/news-release/2020/12/02/2138129/0/en/Axsome-Therapeutics-Announces-Positive-Results-from-the-COMET-TRD-Trial-of-AXS-05-in-Patients-with-Treatment-Resistant-Depression.html Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment Rapid and substantial improvement in functioning achieved by 53% of patients at 2 weeks, 64% of patients at 6 weeks (Sheehan Disability Scale), and sustained with long-term treatment Marked or moderate improvement in depression achieved by 49% of patients at 2 weeks, 78% of patients at 6 weeks (Clinical Global Impression), and sustained with long-term treatment ...

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http://www.globenewswire.com/news-release/2020/12/01/2137234/0/en/Axsome-Therapeutics-Announces-Positive-Efficacy-and-Safety-Results-from-Phase-3-COMET-Long-Term-Trial-and-COMET-AU-Trial-of-AXS-05-in-Major-Depressive-Disorder.html

Axsome Therapeutics EPS misses by $0.03 https://seekingalpha.com/news/3632021-axsome-therapeutics-eps-misses-0_03 Axsome Therapeutics (NASDAQ:AXSM): Q3 GAAP EPS of -$0.61 misses by $0.03. Cash of $202.4 M. Axsome believes that its cash at September 30, 2020 along with the committed capital from its $225M term loan facility will be sufficient to fund the Company’s anticipated operations, based on its current operating plans, into at least 2024.

Axsome Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update https://www.globenewswire.com/news-release/2020/11/05/2120907/0/en/Axsome-Therapeutics-Reports-Third-Quarter-2020-Financial-Results-and-Provides-Business-Update.html COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine completed NDA submissions for AXS-05 in depression expected in January 2021, and for AXS-07 in migraine expected in 1Q 2021 Launch readiness activities progressing with buildout of Digital-Centric Commercialization (DCC) platform Efficacy results from three Phase 2 open-label efficacy trials of AXS-05 in TRD, antidepressant unresponsive MDD, and suicidal ideation, on track for 4Q 2020 Efficacy results from MOVEMENT Phase 3 open-label trial of AXS-07 in migraine expected in 4Q 2020 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation on track for initiation in 4Q 2020 Phase 3 trial of AXS-12 in narcolepsy on track for initiation in 1Q 2021 FDA meeting for AXS-14 in fibromyalgia scheduled for 1Q 2021 ...

Axsome Therapeutics and Veeva Systems Partner to Build Axsome’s Digital-Centric Commercialization Platform http://www.globenewswire.com/news-release/2020/11/04/2119995/0/en/Axsome-Therapeutics-and-Veeva-Systems-Partner-to-Build-Axsome-s-Digital-Centric-Commercialization-Platform.html

Aber was hat das jetzt mit Axsome zu tun 🤔? Ich muss mir doch eh bei jedem Wert selbst ein Bild machen - egal, was andere von sich geben.