AVXL Shares Slump Pre-Market After EMA Committee Fails To Recommend Approval For Alzheimer’s Drug

• CHMP provides recommendations to the EMA on human medicines, which the agency uses to approve or reject a drug.
• However, the drug didn’t feature on the list of medicines for which applications were withdrawn following a meeting with the committee. 
• Anavex confirmed on Friday that it was informed by the CHMP of a negative trend vote on its application for Blarcamesine following its oral explanation.

Shares of Anavex Life Sciences (AVXL) slumped 45% in the premarket session on Friday after a European Medicines Agency (EMA) committee did not recommend a much-awaited approval for the company’s Alzheimer’s drug Blarcamesine.

Retail investors were looking forward to the Committee for Medicinal Products for Human Use’s opinion on the drug after it placed Blarcamesine on its agenda for oral explanations and regulatory review during the session scheduled from Nov. 10 to Nov.13, with the oral explanation held behind closed doors on Nov. 11.

CHMP Avoids Recommendation For Blarcamesine

The CHMP released its meeting highlights on Friday and recommended approval for ten new medicines, but Blarcamesine did not feature on the list. CHMP provides recommendations to the EMA on human medicines, which the agency uses to approve or reject a drug. The lack of a positive recommendation dampens chances for an EMA approval for the drug.

However, the drug also didn’t feature on the list of medicines for which applications were withdrawn following a meeting with the committee.

Anavex confirmed on Friday that it was informed by the CHMP of a negative trend vote on its application for Blarcamesine following its oral explanation. The committee is expected to adopt a formal opinion on the application at its December meeting, the company said, while adding that it intends to request a re-examination of the committee’s opinion.

Anavex submitted an application to the EMA for Blarcamesine in November 2024 based on data from a Phase 2b/3 trial, and the agency subsequently accepted it in December. If the application is approved, it would allow Blarcamesine to be marketed in all EU member states.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around AVXL stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.

AVXL stock is down 47% this year and by 29% over the past 12 months. 

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