Aug. 7 at 2:20 PM
$AVXL has officially resubmitted its answers to the EMA, and the regulatory clock restarted on July 21, 2025 for the MAA of blarcamesine (Alzheimer’s).
👉 Based on standard EMA timelines:
• CHMP opinion expected ~early November 2025
• Full EU marketing authorization likely by Dec 2025 / Jan 2026
If the CHMP delivers a positive opinion, this could be the first oral disease-modifying treatment for Alzheimer’s approved in Europe. Major catalyst ahead.