Anavex Joins ACCESS-AD, a Major Initiative Funded by the European Commission, Through the Clinical Evaluation of Blarcamesine as Part of a Precision Medicine Approach in Alzheimer’s Disease

Rhea-AI Summary

Anavex (Nasdaq: AVXL) announced participation as a key industry partner in ACCESS-AD, a five-year European Commission-funded initiative to accelerate adoption of diagnostic and therapeutic approaches for Alzheimer’s disease.

Blarcamesine, an investigational once-daily oral small molecule that targets autophagy via SIGMAR1, will be evaluated in a clinical prediction study using harmonised neuroimaging, blood biomarkers, digital measures and AI decision support across specialty and community settings in Europe.

The program aims to assess patient characteristics, treatment-response predictors and real-world feasibility; the release notes this is investigational and does not convey conclusions about efficacy or safety.

Positive

• Selected for ACCESS-AD, a European Commission-funded 5-year program
• Blarcamesine included in Europe-wide harmonised imaging and biomarker research
• Oral, once-daily small-molecule therapy evaluated for precision-medicine use

Negative

• Blarcamesine remains investigational with no guarantee of approval
• ACCESS-AD targets real-world bottlenecks in diagnosis and imaging capacity

News Market Reaction – AVXL

+8.16%

28 alerts

+8.16% News Effect

+7.9% Peak in 3 hr 59 min

+$33M Valuation Impact

$435M Market Cap

0.8x Rel. Volume

On the day this news was published, AVXL gained 8.16%, reflecting a notable positive market reaction. Argus tracked a peak move of +7.9% during that session. Our momentum scanner triggered 28 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $33M to the company's valuation, bringing the market cap to $435M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Program duration: 5 years Projected AD prevalence: 19 million Europeans Dosing frequency: Once-daily oral

3 metrics

Program duration 5 years ACCESS-AD initiative funded by the European Commission

Projected AD prevalence 19 million Europeans Alzheimer’s disease prevalence projection by 2050 in Europe

Dosing frequency Once-daily oral Blarcamesine administration regimen in ACCESS-AD clinical evaluation

Market Reality Check

Price: $4.46 Vol: Volume 982,832 is below t...

low vol

$4.46 Last Close

Volume Volume 982,832 is below the 20-day average of 2,281,545, suggesting limited pre-news positioning. low

Technical Shares at $4.29 are trading below the 200-day MA of $8.13 and 69.34% under the 52-week high.

Peers on Argus

AVXL was up 0.23% with mixed biotech peers: GERN up 5.93%, ZBIO up 14.77%, while...

1 Up

AVXL was up 0.23% with mixed biotech peers: GERN up 5.93%, ZBIO up 14.77%, while PRAX and TNGX fell. Only ZBIO appeared on the momentum scanner, indicating this ACCESS-AD news looked stock-specific rather than part of a broad sector rotation.

Historical Context

5 past events · Latest: Jan 08 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 08	Leadership appointment	Positive	+4.2%	Hired senior neurology leader with extensive CNS trial experience.
Jan 06	FDA program feedback	Positive	+1.5%	FDA Type C meeting and collaborative feedback on AD program.
Dec 18	EMA re-exam request	Neutral	-0.8%	Requested EMA re-examination of blarcamesine opinion.
Dec 12	EU regulatory setback	Negative	+3.0%	CHMP issued negative opinion on blarcamesine MAA.
Nov 26	Clinical data update	Positive	+11.6%	Presented CTAD data showing precision-medicine population signals.

Pattern Detected

Recent AVXL headlines, especially around blarcamesine and Alzheimer’s programs, have often coincided with positive or resilient price reactions, even around mixed or negative European regulatory updates.

Recent Company History

Over the last few months, AVXL has focused on advancing blarcamesine and strengthening its neurology leadership. On Nov 26, 2025, CTAD data on oral blarcamesine drove an 11.56% gain. A subsequent Dec 12 CHMP negative opinion still saw shares rise 2.99%, followed by a Dec 18 EMA re-examination request with only a modest move. Early January 2026 brought FDA feedback on the Alzheimer’s program and a senior neurology hire, both with positive but measured price reactions. Today’s ACCESS-AD collaboration fits this ongoing precision-medicine and regulatory-engagement narrative.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-07-14

The company has an active S-3 shelf registration filed on 2025-07-14 with at least one recorded usage via a 424B5 prospectus on 2025-07-25, indicating pre-established capacity to raise capital if management chooses.

Market Pulse Summary

The stock moved +8.2% in the session following this news. A strong positive reaction aligns with AVX...

Analysis

The stock moved +8.2% in the session following this news. A strong positive reaction aligns with AVXL’s pattern of responding well to clinical and collaboration news on blarcamesine. Integration into ACCESS-AD adds real-world, biomarker-rich data in Alzheimer’s care, which could complement prior Phase 2b/3 results and ongoing EMA/FDA interactions. However, shares trading far below the 200-day MA at $8.13 and an active S-3 shelf filed on 2025-07-14 highlight ongoing financing and execution risks that could temper sustainability.

Key Terms

autophagy, sigmar1, precision-medicine, biomarkers, +3 more

7 terms

autophagy medical

"small-molecule therapy designed to target autophagy through SIGMAR1 activation"

Autophagy is a natural cellular process where cells break down and recycle damaged parts and unwanted material, like a house cleaning system that removes clutter to keep things running smoothly. For investors, autophagy matters because many drugs and therapies aim to boost, inhibit, or redirect this process to treat diseases; success or failure in manipulating autophagy can affect the commercial prospects and valuation of biotech companies.

sigmar1 medical

"through SIGMAR1 activation, a central regulator of cellular homeostasis"

SIGMAR1 is the gene that produces the sigma‑1 receptor, a protein that acts like a cellular switchboard, coordinating how cells respond to stress, manage calcium signals and control other proteins. It’s a frequent drug target because changing its activity can protect nerve cells, alter brain chemistry or affect tumor behavior; for investors, SIGMAR1 appears in pipelines and trial results as a signal of possible therapeutic value or regulatory risk.

precision-medicine medical

"potential precision-medicine therapeutic approach aiming to restore cellular function"

Precision medicine is an approach to preventing and treating disease that tailors decisions and therapies to an individual’s genetic makeup, environment, and lifestyle—like tailoring a suit to a person instead of using one-size-fits-all clothing. For investors it matters because these targeted treatments can be more effective but often serve smaller patient groups, which affects potential market size, development cost, regulatory hurdles and pricing power, shaping risk and return profiles for healthcare investments.

biomarkers medical

"integrates advanced neuroimaging, blood-based biomarkers, digital measures"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

digital measures technical

"blood-based biomarkers, digital measures and AI-driven decision support"

Digital measures are quantifiable pieces of information collected through electronic tools—like websites, mobile apps, sensors, or wearables—that track behavior, performance or health outcomes. For investors they matter because they turn activity into timely, objective data (think of a car’s dashboard gauges) that can reveal user growth, product engagement, clinical response, or operational issues faster than traditional reports, helping assess a company’s momentum and risk.

ai-driven decision support technical

"digital measures and AI-driven decision support to create streamlined"

AI-driven decision support is software that uses artificial intelligence to analyze large amounts of data and present concise recommendations or scenarios to help humans make choices—think of it as a smart co-pilot or GPS for business decisions. For investors, it matters because it can speed up research, surface hidden patterns, reduce routine errors, and highlight risks or opportunities faster than manual analysis, potentially affecting a company’s performance, costs and competitive edge.

disease-modifying therapies medical

"approvals of antibody-based disease-modifying therapies (DMTs) have expanded"

Disease-modifying therapies are treatments intended to change the underlying course of a chronic illness by slowing, stopping, or reversing the biological process that causes harm, rather than only relieving symptoms. For investors they matter because therapies that alter disease progression can reach more patients, support longer-term use and higher pricing, and shift risk/reward profiles in development and approval — like repairing a building’s foundation instead of patching visible cracks.

AI-generated analysis. Not financial advice.

NEW YORK, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), today announced its participation as a key industry partner in ACCESS-AD, a major new European initiative designed to accelerate the adoption of innovative diagnostic and therapeutic approaches for Alzheimer’s disease (AD) across real-world clinical settings. The five year program is funded by the European Commission’s Innovative Health Initiative (IHI) and unites leading academic centers, technology developers, industry innovators and patient organizations to strengthen equitable access to timely and effective AD care.

ACCESS-AD launches at a pivotal time for Alzheimer’s disease management in Europe. Recent approvals of antibody-based disease-modifying therapies (DMTs) have expanded the treatment landscape, but health systems continue to face substantial bottlenecks in diagnosis, patient stratification, imaging capacity and ongoing monitoring. With AD prevalence projected to exceed 19 million Europeans by 2050, scalable and accessible therapeutic options—especially those that reduce reliance on high-intensity healthcare infrastructure—are urgently needed.

Advancing Precision Medicine for Alzheimer’s Disease

As part of the consortium, blarcamesine, the once-daily orally administered investigational small-molecule therapy designed to target autophagy through SIGMAR1 activation, a central regulator of cellular homeostasis, will be evaluated in a clinical prediction study. Blarcamesine is being developed as a potential precision-medicine therapeutic approach aiming to restore cellular function and slow neurodegenerative processes underlying Alzheimer’s disease.

ACCESS-AD is establishing a coordinated, multimodal clinical framework that integrates advanced neuroimaging, blood-based biomarkers, digital measures and AI-driven decision support to create streamlined patient pathways across Europe. The platform is designed to support early detection, personalised treatment choices and safe implementation of emerging therapies.

Integrating Blarcamesine into a Europe-Wide Innovation Framework

The inclusion of blarcamesine within ACCESS-AD’s real-world research program enables the generation of predictive clinical insights using harmonised imaging, biomarker and digital datasets. The blarcamesine study will examine patient characteristics, treatment response predictors and real-world feasibility within both specialty and community-based clinical environments. The effort aligns with Anavex’s long-standing commitment to developing precision medicine approaches that incorporate clinical data, genomic markers and digital endpoints. This will allow the consortium to explore how molecular-targeted, orally available therapies can complement the AD treatment ecosystem.

“We are pleased that blarcamesine will be evaluated within ACCESS-AD’s innovative precision-medicine framework,” said Christopher U. Missling, PhD, President & CEO of Anavex. “This initiative represents a unique opportunity to integrate advanced biomarker data and digital tools with a therapy that is intentionally designed to be accessible, scalable and compatible within diverse healthcare environments. We look forward to contributing to a future in which personalised care is available to all people living with Alzheimer’s disease.”

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

About Alzheimer’s disease

Alzheimer's disease is the most common cause of dementia, accounting for 60-80% of all dementia cases worldwide. Dementia is a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer’s disease is a progressive disease, where symptoms gradually worsen over time. Each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that can slow down the progression of Alzheimer’s disease and reduce the overall burden on people affected and on society.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX^®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX^®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX^®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX^®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX^®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX^®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com

FAQ

What did Anavex (AVXL) announce about ACCESS-AD on January 13, 2026?

Anavex said blarcamesine will be evaluated within ACCESS-AD, a five-year European Commission-funded program to study AD diagnostics and therapeutics across Europe.

What is blarcamesine and how will AVXL study it in ACCESS-AD?

Blarcamesine is an investigational once-daily oral small molecule targeting autophagy via SIGMAR1; it will be assessed in a clinical prediction study using harmonised imaging, biomarkers and digital measures.

How long is the ACCESS-AD program that includes AVXL's blarcamesine?

ACCESS-AD is a five-year initiative funded by the European Commission’s Innovative Health Initiative.

Will the ACCESS-AD evaluation of blarcamesine provide approved labeling or efficacy conclusions for AVXL?

No; the release states the uses are investigational and do not convey conclusions about efficacy or safety, and approval is not guaranteed.

What kinds of data will AVXL generate for blarcamesine within ACCESS-AD?

The study will generate harmonised neuroimaging, blood-based biomarker, digital measure and AI-driven clinical decision support data to examine predictors and real-world feasibility.