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

Heute PDUFA-Termin für AXS-05 (Alzheimer Agitation). Sollte also heute/morgen Bewegung reinkommen

https://goldesel.de/aktien/news/axsome-erhalt-fda-zulassung-fur-auvelity-bei-alzheimer-agitation-aktie-profitiert-nach-pdufa

https://goldesel.de/aktien/news/axsome-therapeutics-lost-sunosi-patentrechtsstreit-vergleich-senkt-ungewissheit-generika-erst-ab-2040

Die Aktie macht doch einfach nur Spaß. Bestes Pferd im Stall!

https://finance.yahoo.com/sectors/healthcare/articles/axsome-therapeutics-acquires-selective-pde10a-110000091.html

Still geworden hier

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-initiates-forward-phase-3-trial-axs-14

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meinen Glückwunsch an alle investiert. 🥂😉👍🏻

https://stocktwits.com/news-articles/equity/markets/axsome-advances-toward-fda-filing-for-drug-to-treat-narcolepsy/cL7B4KPREzL

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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.