Reframing Alzheimer’s Drug Development: Clinical Signals, Regulatory Review, and the Path Forward for ANAVEX®2-73
Thursday, January 8, 2026
11:00 AM – 12:00 PM ET
Review our in-depth fireside chat with Anavex Life Sciences Corp. focused on its lead program, ANAVEX®2-73 (blarcamesine), and the evolving scientific and regulatory landscape surrounding early Alzheimer’s disease. The discussion examines how activation of the Sigma-1 receptor (SIGMAR1) and restoration of autophagy may address fundamental cellular dysfunction in neurodegenerative disease, with implications extending beyond Alzheimer’s into Parkinson’s disease, Rett syndrome, and other CNS indications.
Jason Kolbert, Head of Research at D. Boral Capital, and Christopher U. Missling, PhD, MS, MBA, President and CEO of Anavex, review results from the Phase IIb/III early Alzheimer’s disease trial, a global, multicenter, placebo-controlled 48-week study evaluating blarcamesine. The conversation will cover statistically significant and clinically meaningful improvements observed across key cognitive and functional measures, including ADAS-Cog, ADCS-ADL, and CDR-SB, and how these outcomes fit within today’s regulatory expectations for Alzheimer’s therapies.
A central focus of the discussion will be the recent negative opinion issued by the European Medicines Agency’s CHMP and Anavex’s decision to pursue a formal re-examination. Management will outline the specific issues raised by the CHMP, including manufacturing, tolerability, and efficacy interpretation, and explain why these concerns are viewed as addressable through updated data, refined titration protocols, enhanced manufacturing controls, and a more integrated presentation of biomarker and clinical evidence. The session will also walk through the EMA re-examination process, the significance of a second review by a new assessor group, and how this step could materially reshape the EU regulatory trajectory.
This conversation offers a timely opportunity to hear directly from Anavex leadership on how the company is navigating regulatory scrutiny, strengthening its European filing, and positioning blarcamesine within a rapidly evolving Alzheimer’s treatment paradigm. The discussion will conclude with management’s strategic priorities and outlook as the company enters 2026.
Jason Kolbert
Head of Research
D. Boral Capital











