Anavex Sciences Soars On Earnings Relief, EU Filing Acceptance For Alzheimer’s Drug: Retail’s Overjoyed

Anavex Life Sciences Corp. shares rocketed over 27% on Monday, hitting their highest levels since February 2023, fueled by a mix of positive earnings results and regulatory progress in Europe.

The biopharma company, focused on neurodegenerative and neurodevelopmental diseases, reported a fiscal fourth-quarter loss of $11.6 million, or an adjusted $0.14 per share, compared to a loss of $10.1 million in the year-ago period. 

While research and development (R&D) and overhead costs rose, the per-share loss was narrower than the FactSet consensus estimate of $0.16.

Anavex also highlighted a strong cash position, with $132.2 million in reserves, which the company says will provide a four-year runway at current burn rates.

Creating more buzz was news that the European Medicines Agency (EMA) accepted the Marketing Authorization Application for blarcamesine (ANAVEX 2-73), an investigational oral drug for Alzheimer’s disease. 

Anavex’s Head of R&D, Juan Carlos Lopez-Talavera, said: "The EMA filing acceptance for blarcamesine to review the Marketing Authorization Application potentially brings us a step closer offering broader patient access to a new treatment option in Europe, and we look forward to continued engagement with the EMA.”

CEO Christoper Missling said, "We are excited about the potential to advance a novel treatment for early Alzheimer's disease with convenient oral dosing and our team remains deeply committed to executing on our momentum.”

AVXL poll, sentiment and message volume on Dec 24 as of 1:30 pm ET | source: Stocktwits

Retail investors on Stocktwits celebrated the news, with sentiment shifting sharply to ‘bullish’ from ‘neutral.’ 

Many hailed the EMA filing as a significant milestone, with one user claiming very high approval rates by the European regulator for “accepted drug candidates in 2024 that aren't withdrawn.”

According to a study published last year in the Clinical and Translational Science, an official journal of the American Society for Clinical Pharmacology and Therapeutics, the EMA was found to have the highest approval rate (93.8%) for non-oncology products when compared with Swiss and U.S. regulators. The data analyzed decisions between 2009 and 2018 on new active substances.

The broader market’s interest in Alzheimer’s therapies remains intense, particularly after Cassava Sciences reported disappointing results for its candidate simufilam last month. 

D. Boral Capital had noted Anavex’s neuroprotective mechanism could position blarcamesine as a superior option, reiterating a ‘Buy’ rating with a $46 price target.

Anavex shares are now up 88% year-to-date.

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