blarcamesine (Anavex 2-73) / Anavex - LARVOL DELTA

Anavex Life Sciences Corp…announced that it has withdrawn its application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer’s disease in adults, which had been under review by the European Medicines Agency (EMA) (Anavex Press Release) - "The decision to withdraw the application follows feedback from the EMA’s Committee for Medicinal Products for Human Use (CHMP) indicating that it would not be in a position to issue a positive opinion for the application at this time."

European regulatory • Alzheimer's Disease

STUDY OF BLARCAMESINE IN A NEW PARKINSON'S MODEL OF COMBINED ΑLPHA-SYNUCLEIN PATHOLOGY AND NORADRENERGIC DYSFUNCTION (ADPD 2026) - "The motor deficit caused by alpha-synuclein pathology combined with noradrenergic dysfunction was significantly attenuated after 6 weeks of blarcamesine treatment. This was accompanied by a restoration of DA fibers in the most denervated striatal regions, without any significant change in number of nigral DA neurons or pSyn inclusions. We conclude that blarcamesine has restorative effects on nigrostriatal dopaminergic neurons even in the presence of alpha-synuclein aggregates formation."

CNS Disorders • Movement Disorders • Parkinson's Disease

ADVANCING ALZHEIMER'S DISEASE CARE: CONVENIENCE FOR BOTH PATIENTS AND FAMILIES WITH ORAL BLARCAMESINE WITH LONG-TERM TIME SAVED (ADPD 2026) - "The impact on daily life is extended by time saved with oral Alzheimer's treatment blarcamesine¾here 17.8 months¾allowing for longer independence of loved ones¾with safer and better outcome¾while allowing efficiency, accessibility, and ease for patients and families."

Clinical • Alzheimer's Disease • CNS Disorders

Anavex Life Sciences Presents New Data from its AD-004 Phase IIb/III Trial at AD/PD 2026 Conference Demonstrating Consistent Correlation Between the Treatment Effect of Oral Blarcamesine and Preservation of Brain Volume in Early Alzheimer’s Disease (Anavex Press Release) - "A dedicated analysis of MRI biomarkers demonstrated a highly consistent correlation between slowing of atrophy and improvements across primary and secondary clinical endpoints, including: ADAS-Cog13 (cognition); ADCS-ADL (activities of daily living); CDR-SB (global clinical cognitive and functional outcome)...In the genetically defined ABCLEAR32 precision medicine population, the correlation (R²) strength improved markedly, with R² increasing by 78% for ADAS-Cog13 (from R²=0.23 to R²=0.41)—firmly within the “very suggestive” range for clinical relevance."

P2/3 data • Alzheimer's Disease

New Scientific Findings Highlight Hypothesis of Autophagy Failure as a Precursor of Amyloid Beta and Tau Pathology in Alzheimer’s Disease (GlobeNewswire) - "The authors further provide an explanation why amyloid plaques, or oligomers of Aβ, do not play a primary role, which allows for accommodation of the disconnect between the prevalence of plaques within the brain and cognitive status. Also, the role of apolipoprotein E (APOE) expression, being the largest genetic risk factor in sporadic Alzheimer’s disease could be explained. APOE is thought to influence Aβ trafficking, which could play an important role by increasing neuronal uptake of extracellular Aβ—thus defeating or competing with beneficial secretion....These findings directly align with Anavex’s clinical and mechanistic data showing that blarcamesine..."

Preclinical • Alzheimer's Disease

Anavex Life Sciences Presents Significant Treatment Effects of Blarcamesine in New Advanced Alpha-Synuclein Model of Parkinson’s Disease at AD/PD 2026 Conference (The Manila Times) - "New Parkinson’s model of combined alpha-synuclein pathology and noradrenergic degeneration...Significant treatment effects of blarcamesine were detected using both a test of impaired motor function and a biomarker of dopaminergic nerve fiber density, indicating fiber regrowth in striatum after 6 weeks of blarcamesine treatment."

Preclinical • Parkinson's Disease

Upcoming milestones, pipeline breadth, and financial position (Yahoo Finance) - "Looking ahead, Missling said the company expects a review of its re-examination with the EMA in the first half of the year...Participation in ACCESS-AD, described as a European-funded initiative, and planning for an Alzheimer’s study; A planned Phase IIb/III Parkinson’s disease dementia study, described as likely around 12 months in duration...Three expected publications: a precision medicine analysis from the Alzheimer’s study, a GWAS/COL24A1 publication..."

New trial • Alzheimer's Disease • Parkinson's Disease

New scientific findings to be presented at upcoming conferences or publications (Anavex Press Release) - "Oral Presentation at 16th Intrinsic Capacity, Frailty and Sarcopenia Research Conference for Healthy Longevity (ICFSR26)...Clinical relationship with biomarker: Correlation between clinical endpoints and reduced brain region atrophy with blarcamesine in early Alzheimer’s disease; Publication Alzheimer’s disease: Precision Medicine ABCLEAR populations of the ANAVEX2-73-AD-004 Phase 2b/3 trial; Publication Alzheimer’s disease: Precision Medicine gene, COL24A1, with estimated >70% prevalence in the early AD population has the potential to establish effective treatment of early Alzheimer’s disease through effectiveness of autophagy-enhancing blarcamesine."

Clinical data • Alzheimer's Disease • Sarcopenia

Expected Development Milestones (Anavex Press Release) - "Update on regulatory pathway for blarcamesine in early Alzheimer’s disease; Progress on clinical development program in Parkinson’s disease through targeted approach, potentially addressing the highest disease burden in Parkinson’s disease; Regulatory and clinical trial update for blarcamesine in Parkinson’s disease....Progressing collaborative initiatives and strategic partnership activities."

Pipeline update • Alzheimer's Disease

Emerging neurobiological targets in psychiatric treatment. (PubMed, Eur Neuropsychopharmacol) - "Recent evidence suggests that sodium channel modulators, such as evenamide, may offer therapeutic benefits for treatment-resistant schizophrenia by stabilizing glutamatergic neurotransmission...Additionally, Sigma-1 receptor agonists, including Blarcamesine and Pridopidine, have shown neuroprotective and cognitive-enhancing properties, making them attractive candidates for psychiatric and neurodegenerative disorders. Orexin receptor antagonists, such as suvorexant and seltorexant, have potential in mood disorders and substance dependence, highlighting the broader therapeutic applications of targeting the orexinergic system...The identification of biomarkers for patient stratification will be critical in the hitherto elusive goal of developing precision medicine approaches. Targeted pharmacological interventions offer a path toward more effective, well-tolerated, and potentially individualized treatment options for patients with severe mental illness."

Journal • Review • Bipolar Disorder • CNS Disorders • Depression • Inflammation • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

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 (The Manila Times) - "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....The blarcamesine study will examine patient characteristics, treatment response predictors and real-world feasibility within both specialty and community-based clinical environments."

Financing • New trial • Alzheimer's Disease

Anavex Life Sciences Receives FDA Feedback on Alzheimer’s Disease Program (The Manila Times) - "During the Type C meeting, the FDA shared their interest and collaborative approach to Anavex’ development plans. The Company provided information related to the scientific rationale and profile of blarcamesine as an oral administration being convenient to dispense and the absence of significant safety concerns in clinical trials of blarcamesine conducted so far extending to the lack of amyloid-related imaging abnormalities (ARIA)...In order to move forward, existing data from the Phase IIb/III ANAVEX2-73-AD-004 program requested by the Agency will be submitted."

FDA event • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - "This post-market approval continuous monitoring platform may benefit all stakeholders, including patients, clinicians, regulators, service providers and payors. This modularly digital platform can be customized to fit also other post-market approval monitoring."

Journal • Alzheimer's Disease • CNS Disorders

Drug Development. (PubMed, Alzheimers Dement) - "Thus, the specificity of blarcamesine to this genotype underscores the importance of understanding clear MoA and potential for further improved personalized medicine in AD treatment, as therapies targeting individual molecular profiles could achieve more substantial and sustained benefits. While Precision Medicine holds great promise for improving the treatment paradigm of AD by offering more personalized, likely more effective therapies, it also introduces challenges related to potential cost, data privacy, ethical concerns, and inequities in access. Addressing these issues is crucial to ensure that the benefits of Precision Medicine can be realized for all patients."

Journal • Alzheimer's Disease • CNS Disorders • SIGMAR1

Drug Development. (PubMed, Alzheimers Dement) - "Blarcamesine significantly reduced clinical decline showing meaningful benefit for early Alzheimer's disease patients. Blarcamesine exhibited a favorable safety profile with no treatment-related deaths and demonstrated no associated neuroimaging adverse events with continued treatment over 4 years. Altogether, these results indicate that blarcamesine may be an effective, safe, and novel scalable oral treatment for early AD."

Journal • Alzheimer's Disease • CNS Disorders

Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion (GlobeNewswire) - "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."

European regulatory • Alzheimer's Disease

Oral Blarcamesine Comparison to Normal Cognitive Aging: Demonstrating Alignment with Prodromal Cognitive Aging Trajectories in Precision Medicine Patient Population Phase IIb/III Trial–for Early Alzheimer's Disease Patients (CTAD 2025) - No abstract available

Clinical • P2/3 data • P2b data • Alzheimer's Disease • CNS Disorders

Advancing Alzheimer's Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders

Oral Blarcamesine Phase IIb/III Trial Confirms Identified Precision Medicine Patient Population – Significant Broad Clinical and Quality of Life Improvements for Early Alzheimer's Disease Patients (CTAD 2025) - No abstract available

Clinical • HEOR • Late-breaking abstract • P2/3 data • P2b data • Alzheimer's Disease • CNS Disorders

Anavex Life Sciences – Oral Blarcamesine Phase IIb/III trial results (CTAD 2025) - "Sponsored by Anavex Life Sciences"

P2/3 data • P2b data

Negative opinion for one medicine (European Medicines Agency) - "The committee recommended not granting a marketing authorisation for Blarcamesine Anavex (blarcamesine), a medicine intended for the treatment of Alzheimer’s disease. The CHMP concluded that the main study failed to demonstrate the effectiveness and safety of this medicine in patients with early Alzheimer's disease who do not have mutations in the SIGMAR1 gene."

CHMP • Alzheimer's Disease

Anavex Life Sciences to Present Oral Blarcamesine Data at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference (GlobeNewswire) - "Anavex Life Sciences...will present one oral late breaking communication and two poster presentations....'Blarcamesine demonstrated in early Alzheimer’s disease patients clinically meaningful effects of slowing cognitive decline with an adequate safety profile (no ARIA) as demonstrated in the Phase IIb/III program'..."

Clinical data • Alzheimer's Disease

Blarcamesine (ANAVEX®2–73) Attenuates Spasms and Hypsarrhythmia in a Rat Model of Infantile Epilepsy Spasms Syndrome (AES 2025) - "Current FDA-approved management including adrenocorticotropic hormone (ACTH) and vigabatrin, demonstrate efficacy in only 50–60% of cases and often carry significant side effects, such as immunosuppression and visual field deficits. These results highlight the efficacy of blarcamesine to suppress spasms, ameliorate EEG abnormalities, and prevent progression to spontaneous seizures later during development, advancing approaches for managing IESS."

Preclinical • Absence Seizure Disorder • Cardiovascular • CNS Disorders • Developmental Disorders • Epilepsy • CDKN1A

Expected Development Milestones: (StockTitan.net) - "Regulatory and clinical trial update for blarcamesine in early Alzheimer’s disease, Parkinson’s disease, Rett syndrome; Fragile X development update: Design of Phase 2/3 clinical trial"

Clinical • New P2/3 trial • Regulatory • Alzheimer's Disease • Fragile X Syndrome • Genetic Disorders • Parkinson's Disease

Anavex Retail Traders See Silver Lining In EMA Committee Postpones Alzheimer’s Drug Verdict: Delay ’Actually A Positive Sign’ (StockTwits) - "Anavex later confirmed it had received a negative trend vote following its oral explanation and noted that a formal opinion is expected in December. The company also stated that it plans to request a re-examination once the opinion is issued. The drug was not listed among withdrawn applications, leaving the procedure formally open heading into the next meeting."

CHMP • Alzheimer's Disease