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

Seeking Alpha heute: Axsome reports positive data from Major Depressive Disorder study Axsome Therapeutics Inc. (AXSM) announced encouraging results from its GEMINI Phase 3 trial. It was a randomized, double-blind, placebo-controlled, multi-center, U.S. trial, and involved 327 adult patients with confirmed moderate to severe MDD. The data showed that AXS-05 was showed rapid and significant improvement in patient reported outcomes. The patients in GEMINI study were randomized and were administered either AXS-05 or placebo once daily for the first 3 days. Afterwards, the dosage was increased to twice daily and the treatment was continued for 6 weeks in total. Cedric O'Gorman, MD of Axsome said: These patient-reported outcomes mirror the results previously reported with clinician-rated scales and confirm the rapid and substantial antidepressant effects of AXS-05." AXS-05 works through its novel oral glutamatergic mechanism. The drug candidate met its primary endpoint in the trial as it demonstrated a highly statistically significant decline in the MADRS total score compared to placebo at Week 6. The mean reduction from baseline was 16.6 points while for placebo it was 11.9 points. AXS-05 also showed statistically significant progress at Week 6 on the CGI-I. It also resulted in quick progress in depressive symptoms. AXS-05 was also found to be well tolerated in the trial. The most commonly reported adverse events for the treatment cohort included dizziness, headache, nausea, diarrhea, somnolence, and dry mouth. There were no reports pertaining psychotomimetic effects or weight gain. AXS-05 is a novel, oral, non-competitive NMDA receptor antagonist. It is also known as a glutamate receptor modulator. It works by enhancing synaptic connection and improving the communication between brain cells of people suffering from major depressive order. The drug candidate is also a sigma-1 receptor agonist. It helps in boosting brain levels of serotonin, noradrenaline, and dopamine. These are the key neurotransmitters responsible for regulating mood. The FDA granted AXS-05 a Breakthrough Therapy designation for the treatment of MDD in March 2019. GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) was a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial. The primary endpoint of the trial was the change form baseline in the total score of the Montgomery-Åsberg Depression Rating Scale. The trial also evaluated two patient-reported outcomes for depression namely the Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16), and the Patient Global Impression of Improvement (PGI-I) for depression. AXS-05 is believed to work in a different way from currently approved therapies for major depressive disorder. Various components of AXS-05 such as the dextromethorphan and bupropion provide different outputs. Dextromethorphan is a sigma-1 receptor agonist and a nicotinic acetylcholine receptor antagonist. It is also an inhibitor or the serotonin and norepinephrine transporters. The bupropion is a nicotinic acetylcholine receptor antagonist and helps in increasing the bioavailability of dextromethorphan. Investment Thesis: While Axsome stock has been on upward trajectory in the past one year, it has seen some pullback since its last earnings announcement. The latest positive news is expected to add some bounce to the stock. The company has also received positive backing from institutional investors including hedge funds.

Heißt morgen geht sie hoch oder 50% runter...oder was erwartet ihr? Überhaupt eine Reaktion? Komisch das fast 5% runter gerade

Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting https://www.globenewswire.com/news-release/2020/09/21/2096384/0/en/Axsome-Therapeutics-Announces-Expedited-Development-of-AXS-12-for-the-Treatment-of-Narcolepsy-Based-on-FDA-Breakthrough-Therapy-Meeting.html Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021 Extensive patient safety database, previously obtained through Pfizer exclusive license, to support NDA filing Extensive array of completed nonclinical studies sufficient to support NDA filing

Vorstellung der Daten zur Wirksamkeit und Sicherheit von AXS-07 am 23.09. / 12:15 – 12:30 PM Central Time http://www.globenewswire.com/news-release/2020/09/17/2095095/0/en/Axsome-Therapeutics-Announces-AXS-07-Phase-3-Migraine-Trial-Results-Selected-by-the-American-Academy-of-Neurology-Science-Committee-as-Featured-Presentation.html ...Das AAN Science Committee prüfte über 150 bahnbrechende oder aufstrebende wissenschaftliche Abstracts und wählte 12 Präsentationen für die neue AAN Science Highlights-Plattform 2020 aus. Die Ergebnisse der Phase-3-MOMENTUM-Studie waren eines der 12 ausgewählten Abstracts. Laut AAN enthalten die ausgewählten Abstracts zeitnahe, aussagekräftige und innovative Inhalte. ...

Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder https://www.globenewswire.com/news-release/2020/09/14/2092779/0/en/Axsome-Therapeutics-Presents-New-Data-from-GEMINI-Phase-3-Trial-with-AXS-05-Demonstrating-Rapid-and-Significant-Improvements-in-Patient-Reported-Outcomes-in-Major-Depressive-Disord.html Rapid, durable, and statistically significant improvement demonstrated in patient-reported depressive symptoms, as measured by the QIDS-SR-16 total score compared to placebo (p=0.001) Clinical response on the QIDS-SR-16 demonstrated in 53% of patients with AXS-05 compared to 33% for placebo (p<0.001) Significant improvement on the PGI-I demonstrated, with 47% of patients reporting their depression being “very much” or “much” improved with AXS-05 versus 31% with placebo (p=0.007) Statistically significant improvement at week 1 versus placebo in QIDS-SR-16 total score (p=0.016), and PGI-I (p=0.008), compared to placebo Potentially first-and-only, oral NMDA receptor antagonist with multimodal activity for the treatment of depression

Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting https://www.globenewswire.com/news-release/2020/08/31/2086016/0/en/Axsome-Therapeutics-Confirms-Pivotal-Status-and-Advancement-of-AXS-05-for-the-Treatment-of-Alzheimer-s-Disease-Agitation-Based-on-Successful-FDA-Breakthrough-Therapy-Meeting.html

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine https://www.globenewswire.com/news-release/2020/08/20/2081222/0/en/Axsome-Therapeutics-Completes-Successful-FDA-Pre-NDA-Meeting-for-AXS-07-for-the-Acute-Treatment-of-Migraine.html ... "Axsome ist zufrieden mit dem Ergebnis unseres jüngsten Treffens vor der NDA mit der FDA, das die Studien und Daten bestätigte, die in unserer geplanten NDA-Einreichung von AXS-07 zur Akutbehandlung von Migräne vorgelegt werden sollen", sagte Dr. med. Herriot Tabuteau. Chief Executive Officer von Axsome. „AXS-07 verfügt über mehrere Wirkmechanismen und eine schnelle Resorption nach oraler Verabreichung, um verschiedene Migräneprozesse mit dem Ziel einer verbesserten Wirksamkeit anzugehen. Wir bleiben auf dem richtigen Weg, um die Einreichung im vierten Quartal abzuschließen und diese neue potenzielle Therapie für Patienten mit Migräne verfügbar zu machen. “ ...

Axsome Therapeutics EPS beats by $0.12 https://seekingalpha.com/news/3603247-axsome-therapeutics-eps-beats-0_12 Axsome Therapeutics (NASDAQ:AXSM): Q2 GAAP EPS of -$0.49 beats by $0.12. Cash and equivalents of $190.7M. https://www.globenewswire.com/news-release/2020/08/10/2075524/0/en/Axsome-Therapeutics-Reports-Second-Quarter-2020-Financial-Results-and-Provides-Business-Update.html Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update

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https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-receives-fda-breakthrough-therapy-1?field_nir_news_date_value[min]=

Weiß jemand etwas über AXS-05 für bipolare Depression? Noch nie davon gehört...

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Axsome liefert weiterhin eine Reihe positiver Katalysatoren für verschiedene Pipeline-Moleküle. Trotz unterdurchschnittlicher Daten für die behandlungsresistente Depression erzielte AXS-05 für andere Franchise-Unternehmen äußerst robuste Ergebnisse. Insbesondere verzeichnete AXS-05 die starken Phase-3-Ergebnisse sowohl für die Major Depression als auch für die Alzheimer-Krankheit. Der nächste große Katalysator für AXS-05 sind die Daten für bipolare Depressionen.

60 Euro in Reichweite. Meine Prognose trifft ein 😉

Novavax, IBio, Biontech oder Moderna

Ne bin nicht mehr investiert. Gibt momentan bessere Biotechaktien