ANAVEX LIFE SCIENCES (AVXL) Company Report

Anavex Life Sciences reported a net loss of $9.8 million, or $0.11 per share, for the fourth quarter of fiscal year 2025.
As of September 30, 2025, the company's cash position was $102.6 million with no debt, and it anticipates a cash runway of more than three years based on the current cash utilization rate.
For Blarcamesine, Anavex expects the CHMP to adopt a negative opinion on its Marketing Authorization Application (MAA) in Europe at its December meeting but intends to request a re-examination. The company has also had initial contacts with US authorities regarding its Alzheimer's disease program.
Anavex announced positive top-line results from its placebo-controlled Phase 2 clinical study evaluating ANAVEX®3-71 for schizophrenia, successfully achieving its primary endpoint by demonstrating the drug was safe and well tolerated.

Nov 25, 2025, 1:30 PM

Anavex Reports Q4 2025 Financials and Provides Regulatory Updates on Blarcamesine and ANAVEX®3-71

AVXL

Earnings

Guidance Update

New Projects/Investments

Anavex reported a cash position of $102.6 million as of September 30th, 2025, with no debt, and projects a cash runway of more than three years at the current utilization rate. For Q4 2025, the company recorded a net loss of $9.8 million, or $0.11 per share, with research and development expenses of $7.3 million and general and administrative expenses of $3.5 million.
The company anticipates a negative opinion from the CHMP in December regarding the Marketing Authorization Application (MAA) for Blarcamesine in Europe but plans to request a re-examination of this decision. Anavex has also initiated discussions with US authorities (FDA) concerning its Alzheimer's disease program.
For the re-examination of Blarcamesine, Anavex intends to present additional biomarker data, including objective brain atrophy measurements and their correlation with cognitive improvements, alongside AbClear subpopulation data related to the Sigma-1 wild type and Collagen 24A1 gene.
The ANAVEX®3-71 SZ001 study yielded encouraging Phase 2 results in schizophrenia, showing a reduction in neuroinflammatory markers and positioning the drug for pivotal trials in depression and psychosis indications.

Nov 25, 2025, 1:30 PM

Anavex Reports Q4 2025 Financial Results and Pipeline Updates

AVXL

Earnings

Guidance Update

New Projects/Investments

Anavex reported a net loss of $9.8 million or $0.11 per share for Q4 2025, with a cash position of $102.6 million as of September 30th, and anticipates a cash runway of more than three years at the current utilization rate.
For Blarcamesine, the company expects the CHMP to adopt a negative opinion on its Marketing Authorization Application (MAA) in Europe in December but plans to request a re-examination; initial contacts have also been made with U.S. authorities regarding the Alzheimer's disease program.
Anavex announced positive top-line results from its placebo-controlled phase II clinical study of ANAVEX3-71 for schizophrenia, successfully achieving its primary safety endpoint and showing encouraging trends in secondary and exploratory analyses.
New long-term clinical data for Blarcamesine demonstrated continued benefit in early Alzheimer's disease patients, showing a significant reduction in cognitive decline and translating to 17.8 months of time saved compared to the ADNI control group.

Nov 25, 2025, 1:30 PM

Anavex Life Sciences Reports Q4 2025 Financial Results and Key Clinical Updates

AVXL

Earnings

Guidance Update

New Projects/Investments

Anavex Life Sciences Corp. reported a net loss of $9.8 million, or $0.11 per share, for the fourth quarter of fiscal 2025, with research and development expenses of $7.3 million.
The company maintained a strong financial position with cash and cash equivalents of $102.6 million as of September 30, 2025, projecting a cash runway of more than 3 years.
Anavex announced a negative trend vote from the CHMP on the Marketing Authorisation Application for blarcamesine, but intends to request a re-examination.
The company also reported positive topline results from its Phase 2 clinical study for ANAVEX®3-71 in schizophrenia, successfully achieving its primary safety endpoint.

Nov 25, 2025, 12:30 PM

Anavex Life Sciences Corp. provides regulatory update on Blarcamesine for early Alzheimer's disease

AVXL

Product Launch

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative trend vote on Anavex Life Sciences Corp.'s Marketing Authorisation Application (MAA) for blarcamesine for early Alzheimer's disease.
Anavex Life Sciences Corp. intends to request a re-examination of the CHMP opinion upon its formal adoption, planning to provide relevant biomarker data.
The U.S. FDA's Center for Drug Evaluation and Research (CDER) has advised Anavex Life Sciences Corp. to schedule a meeting to discuss the company’s Alzheimer's disease clinical trial results.

Nov 14, 2025, 12:42 PM