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Shares of Anavex Life Sciences Corp. (AVXL) fell 3% after hours on Friday after the company said that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a negative opinion on its application seeking approval for the drug Blarcamesine in treating Alzheimer’s disease.
In November, Anavex said it was informed by the CHMP of a negative trend vote on its application for Blarcamesine following its oral explanation in a session held behind closed doors on Nov. 11. The company was awaiting a formal opinion from the committee.
Anavex said on Friday that the CHMP has indeed adopted a negative opinion “as expected.” 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.
The company now intends to request a re-examination of the opinion which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first 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.
Besides Alzheimer’s, Anavex is also studying Blarcamesine in treating Parkinson's disease dementia and Rett syndrome.
On Stocktwits, retail sentiment around AVXL stock rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.
A Stocktwits user opined that this is the best time for big pharma players “to throw bone for this company” provided the low share price and “promising assets.”
AVXL stock is down 63% this year and by 52% over the past 12 months.
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