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

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

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 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

A Systematic Review and Network Meta Analysis of Pharmacologic Disease-Modifying Therapies for Early Alzheimer's Disease (ISPOR-EU 2025) - "Comparators were standard of care (SoC), which may include acetylcholinesterase inhibitors and/or memantine, or any other listed intervention...Following a feasibility assessment, seven RCTs, investigating five DMTs (lecanemab, donanemab, blarcamesine, ALZT-OP1a/1b, and AGB108) were included in the NMA... Several AD DMTs are in the horizon. The RR of SAEs should be considered, when considering alternative AD treatment classes to mitigate the risk of ARIAs."

Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Dementia

Anavex Life Sciences (AVXL, Financial) faces a critical regulatory review by the European Medicines Agency (EMA) for its lead drug, ANAVEX 2-73. (Gurufocus) - "Anavex Life Sciences (AVXL) experienced a significant stock drop of approximately 9% following the European Medicines Agency's (EMA) request for an oral explanation regarding its lead drug, ANAVEX 2-73 (blarcamesine). This drug, aimed at treating Alzheimer's disease and dementia, will be discussed on November 11 at the EMA’s Committee for Medicinal Products for Human Use (CHMP)."

CHMP • Alzheimer's Disease

Anavex Life Sciences Announces Continued Long-Term Benefit from Oral Blarcamesine Compared to Decline Observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) Control Group (GlobeNewswire) - "Externally matched control participants from the ADNI database were compared with participants over the 144-week period of ANAVEX2-73-AD-004 and its ATTENTION-AD (ANAVEX2-73-AD-EP-004) open-label extension (OLE) Phase IIb/III trial...In the intent-to-treat (ITT) population, significantly less cognitive decline was observed for the blarcamesine participants compared to the ADNI control group at 48 weeks with a significant, and clinically meaningful difference in mean change from baseline ADAS-Cog13 total score of −2.68 points (p < 0.0001)....Over the course of the open-label extension study at time point 96 weeks, these two groups diverged sharply, with statistically significant differences in mean change in ADAS-Cog13 total score at 96 weeks of −6.41 points (p < 0.0001). The difference between groups continues to increase at 144 weeks (ADAS-Cog13 total score difference of −12.78 points; p < 0.0001)."

P2/3 data • Alzheimer's Disease

Presentation title: “Advancing Alzheimer’s Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine” (GlobeNewswire) - "Anavex Life Sciences...announced that Prof. Dr. Timo Grimmer...gave an oral presentation....at the 35th Alzheimer Europe Conference ‘Connecting Science and Communities: The Future of Dementia Care’."

Clinical • Alzheimer's Disease

Receptor subtype specific modulation of muscarinic pathways: a mechanistically distinct therapeutic strategy for schizophrenia (ECNP 2025) - "VU0152100, a selective M4 PAM, exhibits antipsychotic-like effects in rodent models, reducing amphetamine induced locomotor hyperactivity and reversing behavioral deficits...NBI-1117568, a selective M4 orthosteric agonist in Phase 2 trials for schizophrenia, attenuates dopaminergic hyperactivity and restores sensorimotor gating without sedative or motor impairments. Blarcamesine has shown neuroprotective and cognitive enhancing effects in multiple models... Targeting mAChRs, particularly M1 and M4, provides a receptor subtype specific strategy to address unmet needs in schizophrenia. KarXT and emraclidine represent leading agents in clinical development. Emerging modulators such as BQCA, AC-42, and the VU series highlight the diversity of mechanisms and potential for precision treatment tailored to receptor expression profiles and schizophrenia endophenotypes [3]."

CNS Disorders • Psychiatry • Schizophrenia