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

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Axsome Therapeutics (NASDAQ: AXSM) received formal FDA pre-NDA meeting minutes supporting an NDA submission for AXS-12 (reboxetine) to treat cataplexy in narcolepsy. The FDA agreed the company’s regulatory data package would be sufficient for an NDA filing. Axsome anticipates completing the NDA submission in January 2026, with acceptance subject to the FDA’s review of the complete filing. AXS-12 clinical work includes three controlled efficacy trials and a completed long-term safety trial. AXS-12 holds Orphan Drug Designation, which may provide seven years of U.S. market exclusivity and potential user-fee waiver if approved.

Axsome Therapeutics (NASDAQ: AXSM) announced the FDA has accepted and granted Priority Review to its supplemental NDA for AXS-05 for treatment of Alzheimer’s disease agitation, with a PDUFA target action date of April 30, 2026. The filing follows a comprehensive clinical program including four randomized, double-blind, controlled Phase 3 trials and a long-term safety trial. The FDA previously granted Breakthrough Therapy designation for AXS-05 in June 2020. Company commentary cites that up to 76% of people with Alzheimer’s experience agitation and that approved treatments are scarce.

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-acquires-subtype-selective-gaba-receptor

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-reports-third-quarter-2025-financial-results

https://www.forbes.com/sites/amyfeldman/2025/10/01/this-haiti-born-doctor-built-a-6-billion-business-developing-drugs-for-depression-and-alzheimers/

Das nervt heute Morgen 5 % und nu 4% runter

Bin jetzt bei 90 auch zum x-ten Mal eingestiegen

Was los heut'?

Bin zum 2.Mal eingestiegen, bei 91€.Letztes Mal für 78€ gekauft und bei bei 127€ verkauft.Hoffe, es geht wieder auf über 120€

Wird jetzt auf jeden Fall erst mal wieder steigen

Bei 91 Euro bzw. 10w wieder eingestiegen. Gucken wir weit ich gehe. Wahrscheinlich wieder so 117 US Dollar. Vielleicht auch mehr

Eigentlich alles super. Mal schauen wie sie den Kurs runterprügeln.

https://finance.yahoo.com/news/axsome-therapeutics-reports-first-quarter-110000784.html

https://www.bisnow.com/new-york/news/office/axsome-therapeutics-inks-96k-sf-sublease-at-1-world-trade-128941

Hallo miteinander. War bisher immer ein stiller Mitleser dieses Forums, aber mich würde ja jetzt schon mal eure Meinung interessieren bzgl des heutigen Abverkaufs?