Anavex Life Sciences Provides Update on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease

Rhea-AI Summary

Anavex Life Sciences (Nasdaq: AVXL) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorisation application for blarcamesine to treat early Alzheimer’s disease following an oral examination in November.

The company intends to request a CHMP re-examination; EMA rules allow a re-examination by a different set of reviewers who will conduct a new, independent assessment. The release reiterates that investigational uses are not conclusions about efficacy or safety and that approval is not guaranteed.

Positive

• Company intends to request CHMP re-examination
• Re-examination will be conducted by a different set of reviewers
• Company committed to continued regulatory dialogue on blarcamesine

Negative

• CHMP adopted a negative opinion on the MAA for blarcamesine
• Negative trend-vote followed the November oral examination

Market Reality Check

$4.02 Last Close

Volume Pre‑news volume of 1,562,348 is below the 20‑day average of 4,337,495 (relative volume 0.36x). low

Technical Shares at $4.11 are trading well below the 200‑day MA of $8.64 and are 71.54% under the $14.44 52‑week high, while sitting 43.71% above the $2.86 52‑week low.

Peers on Argus

Peer biotech moves were mixed, with names like GERN up 9.02% and others such as AVBP and TNGX modestly negative, suggesting this EU regulatory setback for AVXL is company‑specific rather than part of a broad sector swing.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 26	Alzheimer’s data update	Positive	+11.6%	CTAD presentations highlighting Phase 2b/3 blarcamesine benefits and safety signals.
Nov 25	Earnings and update	Neutral	+12.3%	Fiscal Q4 results, cash runway commentary, and mention of CHMP negative trend vote.
Nov 19	Conference appearance	Neutral	+2.9%	Announcement of upcoming J.P. Morgan Healthcare Conference presentation in January 2026.
Nov 18	Earnings date notice	Neutral	-2.2%	Scheduling notice for fiscal 2025 Q4 results and related conference call details.
Nov 14	Regulatory setback	Negative	-35.9%	CHMP negative trend vote on blarcamesine MAA and plan to seek re‑examination.

Pattern Detected

Regulatory updates for blarcamesine have triggered sharp moves, with the earlier CHMP negative trend vote coinciding with a -35.94% drop, while data presentations and business updates have more often seen positive reactions.

Recent Company History

Over the last month, AVXL has alternated between positive data‑ and event‑driven catalysts and regulatory headwinds. On Nov 14, a CHMP negative trend vote on the blarcamesine MAA preceded a -35.94% reaction. Subsequent earnings on Nov 25 highlighted cash resources and reiterated EU plans, and CTAD presentations on Nov 26 emphasized Phase 2b/3 signals, with both dates seeing double‑digit gains. Today’s finalized negative CHMP opinion continues this regulatory thread, following earlier indications of EU scrutiny.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-14

The company has an active Form S-3 shelf registration dated 2025-07-14, with at least one related 424B5 prospectus supplement filed on 2025-07-25. The shelf is noted as not yet effective, but once effective it could facilitate future securities offerings, as indicated by the prior prospectus usage.

Market Pulse Summary

This announcement confirms that the CHMP has issued a negative opinion on the EU marketing authorisation application for blarcamesine in early Alzheimer’s disease, with Anavex planning to request re‑examination by new reviewers. Recent history shows major swings tied to the CHMP’s earlier negative trend vote and subsequent Alzheimer’s data presentations. Investors may focus on the scope of additional evidence provided in re‑examination, the status of other regulatory interactions, and how these developments intersect with the company’s broader CNS pipeline.

Key Terms

Committee for Medicinal Products for Human Use regulatory

"the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had informed"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

CHMP regulatory

"CHMP has adopted a negative opinion on the marketing authorisation application"

The CHMP is the European Medicines Agency’s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker’s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.

marketing authorisation application regulatory

"adopted a negative opinion on the marketing authorisation application for blarcamesine"

A marketing authorisation application is the formal package a drug or medical-device maker submits to a health regulator to get permission to sell a product. Think of it as an application for a sales license: regulators review safety, effectiveness and manufacturing quality before granting permission. Investors watch these submissions because approval unlocks revenue and reduces development risk, while rejection or delays can materially affect a company’s value and timeline.

central nervous system medical

"and other central nervous system (CNS) disorders, today provides an update"

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. 12, 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 provides an update on the regulatory review in the EU for blarcamesine to treat early Alzheimer's disease.

As per previous communication, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had informed Anavex about a negative trend-vote following its oral examination in November. As expected, the CHMP has adopted a negative opinion on the marketing authorisation application for blarcamesine to treat Alzheimer’s disease. The Company intends to request a re-examination of the CHMP opinion. The EMA procedures adopted by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that conduct a new examination, independent from the first opinion.

We believe that the initiated dialogue reinforced our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “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) announce on December 12, 2025 about blarcamesine in the EU?

Anavex said the CHMP adopted a negative opinion on the marketing authorisation application for blarcamesine and the company will request a re-examination.

What is a CHMP re-examination and how does it affect AVXL's blarcamesine review?

A CHMP re-examination is a new assessment by a different set of reviewers; Anavex intends to request this procedure for blarcamesine.

When did the CHMP hold the oral examination that led to the negative trend-vote for AVXL?

The oral examination occurred in November 2025, which preceded the CHMP's negative trend-vote and opinion.

Does the negative CHMP opinion mean blarcamesine is unsafe or ineffective?

The company noted this release discusses investigational uses and does not convey conclusions about efficacy or safety.

Will Anavex (AVXL) pursue further regulatory steps in the EU after the December 12, 2025 update?

Yes, Anavex intends to request a CHMP re-examination as the next regulatory step in the EU.

Where can investors expect official timing for the CHMP re-examination outcome for AVXL?

The company did not provide a timeline; the announcement only states it will request a re-examination under EMA procedures.