Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion

Rhea-AI Summary

Anavex Life Sciences (Nasdaq: AVXL) requested that the European Medicines Agency (EMA) re-examine its opinion on blarcamesine for early Alzheimer’s disease on December 18, 2025.

The company said the re-examination will be led by a different rapporteur and co-rapporteur and that Anavex asked the EMA to consult a Scientific Advisory Group to provide an independent recommendation. Anavex is a clinical-stage biopharmaceutical company developing treatments for Alzheimer’s and other CNS disorders.

The release reiterates that blarcamesine is investigational, that efficacy and safety conclusions are not claimed, and that approval is not guaranteed.

Positive

• Company formally requested an EMA re-examination for blarcamesine
• Re-examination will be evaluated by a different rapporteur team
• Request to involve a Scientific Advisory Group for independent review

Negative

• Blarcamesine remains investigational with no guarantee of approval

Key Figures

Share price $3.92 AVXL price before EMA re-examination news

52-week high $14.4405 52-week trading range high for AVXL

52-week low $2.86 52-week trading range low for AVXL

Cash & equivalents $102.6M Balance at Sept 30, 2025 (fiscal Q4 results)

Q4 net loss $9.8M Fiscal 2025 Q4 net loss (EPS -$0.11)

Q4 R&D expense $7.3M Fiscal 2025 Q4 R&D vs $11.6M prior year

Cash & equivalents $101.164M Balance at June 30, 2025 (10-Q)

ATM facility $150M At-the-market Sales Agreement with TD Securities (10-Q)

Market Reality Check

$3.89 Last Close

Volume Volume 2,884,942 is very close to the 20-day average of 2,899,393, indicating typical trading activity before this announcement. normal

Technical Price $3.92 is trading below the 200-day MA of $8.56, reflecting a weak longer-term trend ahead of the EMA re-examination request.

Peers on Argus

AVXL was down 2.49% ahead of this news. Among key biotech peers, PRAX, ZBIO, AVBP, and TNGX showed declines between -1.8% and -3.72%, while GERN rose 3.32%, suggesting mixed stock-specific moves rather than a unified sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 12	EU regulatory update	Negative	+3.0%	CHMP issued a negative opinion on blarcamesine MAA, re-exam intention stated.
Nov 26	Clinical data update	Positive	+11.6%	CTAD presentations showing Phase IIb/III signals of slowed cognitive decline and safety.
Nov 25	Earnings and pipeline	Positive	+12.3%	Q4 results with >3-year cash runway and ongoing blarcamesine clinical progress.
Nov 19	Conference appearance	Neutral	+2.9%	Announcement of presentation slot at J.P. Morgan Healthcare Conference.
Nov 18	Earnings date notice	Neutral	-2.2%	Scheduling notice for upcoming fiscal 2025 Q4 results and webcast.

Pattern Detected

Recent AVXL news, including regulatory setbacks and data presentations, often coincided with positive price reactions, indicating a tendency for constructive interpretation of complex updates.

Recent Company History

Over the last month, Anavex has reported several key milestones. On Nov 25, 2025, fiscal Q4 results highlighted $102.6M cash and reduced R&D spend, alongside a CHMP negative trend vote, yet shares rose 12.34%. Subsequent CTAD data presentations on blarcamesine for Alzheimer’s on Nov 26 saw an 11.56% gain. The formal CHMP negative opinion on Dec 12 still produced a 2.99% rise. Today’s EMA re-examination request follows this sequence of closely linked regulatory and scientific updates.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-14

Anavex has an active S-3 shelf registration filed on 2025-07-14, expiring on 2028-07-14, with at least one 424B5 prospectus supplement filed on 2025-07-25, indicating it has used the shelf structure to offer securities in line with that filing.

Market Pulse Summary

This announcement clarifies that Anavex has formally asked the EMA to re-examine its opinion on blarcamesine for early Alzheimer’s disease, triggering a fresh review by new rapporteurs and a Scientific Advisory Group. It follows prior CHMP trend and opinion updates and sits alongside a pipeline supported by over $100M in cash and an at‑the‑market facility. Investors may watch for EMA feedback, additional biomarker data, and further regulatory filings as the process advances.

Key Terms

european medicines agency regulatory

"requested the European Medicines Agency (“EMA”) to re-examine its opinion"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

marketing authorization application regulatory

"new evaluation of our marketing authorization application for blarcamesine"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

autophagy medical

"oral treatment options that target the pathology upstream by restoring autophagy"

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.

central nervous system medical

"other central nervous system (CNS) disorders, today announced that it has requested"

The central nervous system (CNS) is the body's main control center, made up of the brain and spinal cord, that processes information and directs movement, sensation and basic functions like breathing. For investors, CNS-related products and research matter because they face long development times, strict safety testing and regulatory hurdles; success or failure can dramatically affect a company’s costs, timelines and potential market value.

AI-generated analysis. Not financial advice.

NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it has requested the European Medicines Agency (“EMA”) to re-examine its opinion on blarcamesine for the treatment of early Alzheimer's disease.

Anavex has requested from the EMA the re-examination, and will work closely with the EMA during this process. The re-examination procedure is led by a different rapporteur and co-rapporteur, who will conduct a new evaluation of our marketing authorization application for blarcamesine. Anavex has also requested that the EMA consult a Scientific Advisory Group as part of this process to provide an independent recommendation.

“There is a significant unmet need for new innovative oral treatment options that target the pathology upstream by restoring autophagy,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer's disease is a neurodegenerative disease that poses significant challenges to those living with Alzheimer's, their care partners and society and our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially new oral treatment options for patients and their families.”

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) request from the EMA on December 18, 2025?

Anavex requested that the EMA re-examine its opinion on blarcamesine for early Alzheimer’s disease.

How will the EMA re-examination of AVXL's blarcamesine be conducted?

The re-examination will be led by a different rapporteur and co-rapporteur performing a new evaluation.

Did Anavex ask for external scientific input during the EMA review?

Yes. Anavex requested the EMA consult a Scientific Advisory Group for an independent recommendation.

Does the December 18, 2025 announcement mean blarcamesine is approved in the EU?

No. The company stated blarcamesine is investigational and that approval is not guaranteed.

What disorders does Anavex (AVXL) focus on besides Alzheimer’s?

Anavex is focused on Alzheimer’s, Parkinson’s, schizophrenia, neurodevelopmental and other CNS and rare disorders.

What should investors expect next after Anavex's EMA re-examination request?

Investors should expect a new EMA evaluation led by new rapporteurs and possible consultation outcomes from the Scientific Advisory Group.