Alterity Therapeutics (ASX:ATH) announced alignment with the US Food and Drug Administration following a pivotal Type C meeting.
The feedback focuses on the development program for ATH434, the company's lead candidate designed to treat multiple system atrophy, a rare and rapidly progressive neurological disorder.
The meeting provided Alterity with formal written support regarding clinical pharmacology and non-clinical development strategies.
The regulatory milestone serves as a critical bridge toward initiating a Phase 3 pivotal trial.
According to CEO David Stamler, the successful dialogue confirms alignment across two key disciplines, effectively setting the stage for imminent discussions on chemistry, manufacturing, and controls and final trial design.
Alterity's progress is bolstered by existing Phase 2 data, which demonstrated clinically meaningful efficacy in a randomised, double-blind, placebo-controlled setting, alongside positive outcomes from open-label trials in advanced MSA patients.
The company remains focused on addressing the underlying pathology of parkinsonian disorders through its patentable drug discovery platform.
Alterity is on track for a crucial End-of-Phase 2 meeting scheduled for mid-year 2026.
At the time of reporting, Alterity Therapeutics' share price was $0.0080.