Shares of Anavex Life Sciences AVXL, a clinical-stage biotech making medicines to treat central nervous system (CNS) diseases, have skyrocketed 94.7% in the past three months due to recent pipeline successes.
Anavex Life Sciences’ clinical developmental pipeline includes two candidates, ANAVEX 2-73 (blarcamesine) and ANAVEX 3-71. Both these candidates are being developed in separate studies across various stages of development to treat a plethora of CNS indications like Alzheimer’s disease (AD), Parkinson’s disease and schizophrenia, among others.
Both these candidates have been developed leveraging Anavex Life Sciences’ proprietary SIGMACEPTOR Discovery Platform, which produces small molecule drug candidates with unique mechanisms of action.
AVXL shares have rallied 53.6% in the past year against the industry’s 12.4% decline.
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Upbeat Initial Data From AVXL’s Schizophrenia Study
In October 2024, Anavex Life Sciences reported positive initial biomarker results from Part A of an ongoing mid-stage study of ANAVEX 3-71 for schizophrenia. This multiple ascending dose portion of the phase II ANAVEX 3-71-SZ-001 study, evaluated two oral, daily doses of the candidate (90 mg or 180 mg) in 16 patients for 10 days.
Per the preliminary data readout, treatment with the candidate demonstrated a dose-dependent effect on two key electroencephalography (EEG) biomarkers in schizophrenia patients, which were more pronounced in the higher dose group. The two concerned EEG biomarkers correlate with positive, negative and cognitive symptoms of schizophrenia, and are typically found in reduced levels in patients. Improvements in these biomarkers potentially lead to reduced auditory hallucinations, improved executive function and working memory, and reduced irritability and anxiety. Additionally, the candidate was overall well-tolerated with no serious adverse events reported.
Anavex believes that ANAVEX 3-71 has the potential to treat all symptom domains of schizophrenia without the side effects of standard-of-care antipsychotics, thereby addressing a significant unmet medical need. Part B of the phase II ANAVEX 3-71-SZ-001 study evaluating the candidate in more schizophrenia patients and over a longer treatment duration is currently ongoing. Top-line safety and efficacy data is expected in the first half of 2025.
Anavex Life Sciences is also evaluating ANAVEX 3-71 for other CNS indications like frontotemporal dementia, neurodegenerative diseases and AD.
AVXL Files MAA for ANAVEX 2-73 for Alzheimer’s
In November 2024, Anavex Life Sciences submitted a marketing authorization application (MAA) for blarcamesine to the EU regulatory body, seeking its approval for treating AD. The filing was accepted for review last month.
The MAA submission is primarily supported by data from the phase IIb/III study in which blarcamesine showed significant clinical improvement over 48 weeks, with a more than 2-point increase in the ADAS-Cog13 score, the primary endpoint. This indicates greater efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Its safety profile eliminates the need for routine MRI monitoring, and its oral administration, combined with its benefits on cognition and neurodegeneration, makes it a convenient and appealing treatment option. The MAA also includes additional safety and efficacy data from the 144-week open-label-extension study of the candidate for AD.
Anavex believes that the EU presents a strong market for AD treatment, with approximately seven million AD patients — a figure projected to double by 2030, per the European Brain Council. The company is also currently evaluating blarcamesine for a variety of other CNS indications, including Parkinson’s disease and Rett syndrome.
Anavex Life Sciences Corp. Price and Consensus
Anavex Life Sciences Corp. Price and Consensus
Anavex Life Sciences Corp. price-consensus-chart | Anavex Life Sciences Corp. Quote
AVXL’s Zacks Rank & Other Stocks to Consider
Anavex currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY. While CSTL and BMRN currently sporta Zacks Rank #1 (Strong Buy) each, ALNY carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $ 1.70. In the past three months, shares of Castle Biosciences have plunged 15.5%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 10.8%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 40 cents. In the past three months, shares of Alnylam Pharmaceuticals have lost 3.3%.
ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.
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