Anavex reports fiscal Q3 2026 results, updates progress on Alzheimer's, Rett, Fragile X programs
Anavex has moved completed Alzheimer's trial data to its FDA IND, sought an FDA meeting on Rett syndrome pediatric inclusion, and plans a Fragile X IND submission in September 2026.
Anavex Life Sciences Corp. reported business updates alongside financial results for the fiscal third quarter ended June 30, 2026, in a release dated August 25, 2026.
On Alzheimer's disease, Anavex has submitted all data from its Alzheimer's disease clinical trials to its newly opened Alzheimer's IND.1 The company said it is using feedback from the European Medicines Agency's CHMP on its Marketing Authorization Application, along with EMA scientific advice and feedback from a Type C meeting held with the FDA in November 2025, to position these completed studies within its overall development plan.1 In June 2026, Anavex received Scientific Advice from the EMA addressing the overall design of the proposed Phase 3 study, ANAVEX2-73-AD-005, covering study population, endpoint hierarchy, treatment duration, statistical framework and subgroup strategy.1 The company said a Phase 3 study in Europe is not being pursued at this time, though it may be considered later.1
For Rett syndrome, Anavex is moving to start an adult Phase 3 study while asking the FDA, through a formal meeting request, to discuss adding pediatric patients to its already-approved protocol for the ANAVEX2-73-RS-005 study.1 That trial is designed as a Phase 3, randomized, double-blind, placebo-controlled study of oral blarcamesine in about 170 participants with Rett syndrome, with a 16-week double-blind treatment period followed by safety follow-up and an optional open-label extension.1
For Fragile X syndrome, the company expects to submit its IND to the FDA in September 2026, supported by an existing Orphan Drug Designation.1
On finances, cash and cash equivalents totaled $118.3 million as of June 30, 2026, versus $102.6 million at fiscal year end September 30, 2025.1 The company said this balance is expected to fund operations into mid to late fiscal 2028.1 Net income for the quarter was $7.8 million, or $0.08 per share, compared with a net loss of $13.2 million, or $0.16 per share, a year earlier.1
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