Blarcamesine

Anavex Life Sciences Corp. submitted the Marketing Authorization Application for Blarcamesine to the European Medicines Agency for Alzheimer's treatment. Blarcamesine, an oral small molecule, showed clinically meaningful improvement in phase 2b/3 trials, with a significant reduction in ADAS-Cog13 scores and slowed neurodegeneration. The drug's safety profile does not require routine MRI monitoring, offering a convenient treatment option. This submission aims to provide new treatment options globally.

Anavex Life Sciences Corp. submitted blarcamesine's MAA to EMA for Alzheimer's treatment, showing clinically meaningful improvement over 48 weeks.

Anavex Life Sciences submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine, an oral Alzheimer's treatment showing 48-week ADAS-Cog13 score improvements >2 points, superior efficacy to existing therapies, and benefits like once-daily oral administration and no routine MRI monitoring.

Anavex Life Sciences announces the acceptance of a peer-reviewed manuscript on blarcamesine for early Alzheimer's disease treatment, with publication expected in Q4 2024/Q1 2025. The company is on track for regulatory submission in Europe.

Anavex Life Sciences announced acceptance of a peer-reviewed manuscript detailing Phase IIb/III trial results of oral blarcamesine for early Alzheimer's disease treatment, to be published in an Alzheimer's-focused medical journal around Q4 2024/Q1 2025, and regulatory submission to the European Medicines Agency (EMA) in Q4 2024.

Anavex Life Sciences announced the acceptance of a peer-reviewed manuscript on blarcamesine for early Alzheimer's treatment in a medical journal, expected Q4 2024/Q1 2025. The company is preparing for regulatory submission in Europe. Alzheimer's affects millions, with significant care costs. Anavex focuses on CNS diseases, with blarcamesine showing potential in clinical trials.

Anavex Life Sciences Corp. (AVXL) shares down 30% in 3 months, trading at $5. Developing therapies for neurodegenerative and neurodevelopmental disorders. Lead candidate Anavex 2-73 showed significant cognitive improvement in Alzheimer's phase 2b/3 study. Also in phase II/III for Rett syndrome (EXCELLENCE trial). ANAVEX 3-71 in phase I for Frontotemporal Dementia, Schizophrenia, and Alzheimer's. Cash and equivalents $154.8 million. Stock range $4.90-$15.24 in last year.

Blarcamesine, an orally bioavailable small molecule activator of the sigma-1 receptor (SIGMAR1), demonstrated slowed clinical progression in Alzheimer disease (AD) patients without the SIGMAR1 rs1800866 gene variant, suggesting greater benefit in these individuals. The phase 2/3 trial, AD-004, involved 508 early-stage AD patients, with 338 receiving blarcamesine and 170 receiving placebo. Results presented at the 2024 CTAD conference showed that wild-type (WT) SIGMAR1 gene carriers experienced significant cognitive benefits compared to the full intent-to-treat population, supporting SIGMAR1 activation as a key mechanism. Blarcamesine also showed reduced brain atrophy and favorable safety profiles, positioning it for potential regulatory submission in Europe.

Anavex's blarcamesine slowed Alzheimer's progression by 36.3% in ADAS-Cog13 over 48 weeks, with 49.8% in SIGMAR1 wild type patients, showing superior efficacy and safety without routine MRI monitoring, with EMA submission planned for Q4 2024.