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

Die positiven Daten von AXS-05 die gestern Nacht veröffentlicht wurden, und AXS-07 welche Morgen veröffentlicht werden, und schon erste positive Indikation gegeben wurde...

Welche news sollten deiner Meinung nach den Kurs so pushen? Die Pipeline ist ja bekannt und meist waren es die Studienergebnisse, die den Auftrieb gegeben hatten.

Mal sehen was über Nacht im Pre passiert

Da ist einiges in der Pipeline

Liest sich sehr gut

https://seekingalpha.com/article/4375569-axsome-therapeutics-axsm-investor-presentation-slideshow?mail_subject=axsm-axsome-therapeutics-axsm-investor-presentation-slideshow&utm_campaign=rta-stock-article&utm_content=link-0&utm_medium=email&utm_source=seeking_alpha

Heute war die TelKo zu AXS-12 und die Daten zu AXS-07 werden eigentlich am 23.09. vorgestellt. Dein Bericht von SA liest sich eher wie eine Zusammenfassung. Betrifft ja neben AXSM noch weitere Pharmawerte.

Zu Phase 3 von 07

Verwirrt mich auch gerade, es soll auf jeden Fall über morgen ne Meldung kommen

🤔🤔

Deine Meldung zu AXS-05 entspricht doch der Meldung vom 14.09., oder? Übermorgen dürfte interessant werden zu AXS-07.

Wobei die Meldung heute ist über AXS-05. Termin morgen AXS-12, angeblich auch AXS-07....

Sie müsste doch eigentlich geradewegs nach oben schießen...?

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