Anavex reported a business update and financial results for the third fiscal quarter ended 30 June.
The company has submitted all data from its Alzheimer’s disease clinical trials to a newly opened Alzheimer’s IND and intends to use EMA feedback and prior FDA interactions to inform a planned Phase 3 design.
Anavex also reported that it received Scientific Advice from the European Medicines Agency in June 2026 addressing study population, endpoints, treatment duration and statistical approach for the proposed Phase 3 study.
The foundational clinical pharmacology program is advancing with the first participant visit completed in the ADME study and the Drug-Drug Interaction study expected to complete its final visit by the end of September.
For Rett syndrome, the company notes FDA Orphan Drug, Rare Pediatric Disease and Fast Track designations for blarcamesine and is initiating an adult Phase 3 while seeking to add pediatric patients through a formal FDA meeting request. The company expects to submit an IND for Fragile X syndrome in September and plans to continue engagements to align clinical paths.
Cash and cash equivalents were $118.3 million as of 30 June 2026, which the company says is expected to fund operations into mid to late fiscal 2028. Nasdaq compliance work and outstanding Form 10-Q filings remain pending as the company works to regain compliance.
