The European Medicines Agency’s CHMP recommended rejecting Anavex Therapeutics’ Alzheimer candidate following a review that raised concerns over product impurities, safety signals and insufficient efficacy data. The committee issued a critical assessment that will delay or block an EU marketing authorisation absent new data or remediation. The CHMP opinion underscores regulatory scrutiny for Alzheimer disease submissions and the challenges companies face proving clinical benefit and manufacturing control. Investors and development partners will be watching Anavex’s response and any plans to address the committee’s safety and quality findings.