Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program – Anavex Life Sciences

Anavex Life Sciences Advances Alzheimer’s Disease Program with FDA Collaboration

Introduction

On January 6, 2026, Anavex Life Sciences Corp. (Nasdaq: AVXL), a clinical-stage biopharmaceutical company specializing in treatments for neurodegenerative and central nervous system (CNS) disorders, announced a significant development in its Alzheimer’s disease clinical program. The U.S. Food and Drug Administration (FDA) invited Anavex to present clinical trial results, demonstrating the Agency’s interest and collaborative approach toward advancing innovative therapies aligned with Sustainable Development Goal (SDG) 3: Good Health and Well-being.

FDA Engagement and Clinical Development

During a Type C meeting, the FDA expressed interest in Anavex’s development plans for blarcamesine, an oral drug candidate. Key points discussed included:

1. The scientific rationale and safety profile of blarcamesine, highlighting the absence of significant safety concerns and amyloid-related imaging abnormalities (ARIA).
2. Potential regulatory pathways to support a New Drug Application (NDA) for Alzheimer’s disease treatment.
3. Submission of existing Phase IIb/III ANAVEX2-73-AD-004 clinical trial data as requested by the FDA.
4. Commitment to ongoing constructive dialogue to facilitate timely evaluation and advancement of the Alzheimer’s disease program.

This collaboration supports SDG 9: Industry, Innovation, and Infrastructure by fostering innovation in healthcare technologies and regulatory science.

Company Leadership Statement

Christopher U. Missling, PhD, President and CEO of Anavex, emphasized the importance of the FDA’s constructive feedback, stating that this collaborative dialogue reinforces the company’s commitment to developing innovative therapies for neurodegenerative diseases. This aligns with SDG 3 by promoting health and well-being through novel medical solutions.

About Alzheimer’s Disease and Societal Impact

Alzheimer’s disease is the leading cause of dementia worldwide, accounting for 60-80% of cases. It is a progressive condition that severely impairs memory and cognitive functions, affecting daily life and placing a significant burden on patients, caregivers, and society. Addressing this unmet medical need contributes directly to SDG 3 by aiming to reduce premature mortality from non-communicable diseases and improve quality of life.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. is dedicated to developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other CNS diseases. The company’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has undergone multiple clinical trials demonstrating potential benefits such as:

• Restoration of cellular homeostasis by targeting SIGMAR1 and muscarinic receptors.
• Neuroprotective, anticonvulsant, anti-amnesic, and anti-depressant properties.
• Potential to halt or reverse Alzheimer’s disease progression.

These efforts contribute to SDG 3 by advancing treatments that improve neurological health and patient outcomes. Additionally, Anavex’s research supports SDG 17: Partnerships for the Goals, through collaboration with organizations like The Michael J. Fox Foundation for Parkinson’s Research.

Forward-Looking Statements

The company notes that statements regarding investigational uses and clinical development are forward-looking and subject to risks and uncertainties. There is no guarantee of regulatory approval or successful completion of clinical trials.

Contact Information

• Anavex Life Sciences Corp.
• Research & Business Development
• Toll-free: 1-844-689-3939
• Investor Relations: Andrew J. Barwicki
• Tel: 516-662-9461

Additional Resources

For more information, visit www.anavex.com and connect with Anavex on Twitter, Facebook, Instagram, and LinkedIn.

1. Sustainable Development Goals (SDGs) Addressed or Connected

1. SDG 3: Good Health and Well-being
   • The article focuses on the development of treatments for Alzheimer’s disease and other neurodegenerative disorders, directly relating to ensuring healthy lives and promoting well-being for all ages.
2. SDG 9: Industry, Innovation and Infrastructure
   • The article discusses clinical trials and innovative drug development, highlighting advances in scientific research and innovation.
3. SDG 10: Reduced Inequalities
   • By addressing diseases like Alzheimer’s and Rett syndrome, which affect vulnerable populations, the article indirectly relates to reducing inequalities in health outcomes.

2. Specific Targets Under Those SDGs Identified

1. SDG 3: Good Health and Well-being
   • Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.
   • Target 3.8: Achieve universal health coverage, including access to quality essential health-care services and access to safe, effective, quality, and affordable essential medicines and vaccines for all.
2. SDG 9: Industry, Innovation and Infrastructure
   • Target 9.5: Enhance scientific research, upgrade the technological capabilities of industrial sectors, including encouraging innovation and increasing the number of research and development workers.
3. SDG 10: Reduced Inequalities
   • Target 10.2: By 2030, empower and promote the social, economic and political inclusion of all, irrespective of age, disability, or other status.

3. Indicators Mentioned or Implied to Measure Progress

1. SDG 3 Indicators
   • Indicator 3.4.1: Mortality rate attributed to cardiovascular disease, cancer, diabetes or chronic respiratory disease.
   • Indicator 3.4.2: Suicide mortality rate (implied through mental health focus).
   • Indicator 3.8.1: Coverage of essential health services, which can include access to innovative treatments like those developed by Anavex.
   • Indicator 3.8.2: Proportion of population with large household expenditures on health as a share of total household expenditure or income (implied in the need for accessible treatments).
   • Clinical trial results and FDA approval progress serve as practical measures of advancement towards treatment availability.
2. SDG 9 Indicators
   • Indicator 9.5.1: Research and development expenditure as a proportion of GDP.
   • Indicator 9.5.2: Researchers (in full-time equivalent) per million inhabitants.
   • Number and phase of clinical trials conducted (Phase 2a, 2b/3, etc.) as indicators of innovation progress.
3. SDG 10 Indicators
   • Indicator 10.2.1: Proportion of people living below 50% of median income, by age, sex and persons with disabilities (implied through focus on diseases affecting vulnerable groups).

4. Table of SDGs, Targets, and Indicators

Source: anavex.com