ATH434-201

July 7, 2026: Alterity Therapeutics (ASX: ATH; NASDAQ: ATHE) reported receipt of official FDA minutes from its End-of-Phase 2 meeting for ATH434 in multiple system atrophy (MSA), confirming the previously announced registrational Phase 3 plan (initially disclosed June 9, 2026) and outlining a path toward a potential NDA.

FDA agreed with Alterity’s proposed Phase 3 design, including study population, dosing regimen, and endpoints. The planned pivotal Phase 3 is expected to enroll ~200 MSA patients randomized 1:1 to ATH434 50 mg or placebo twice daily for 12 months. The primary endpoint is the 11-item UMSARS Part I functional scale; key secondary endpoints include the Swallowing Disturbance Questionnaire (SDQ), Orthostatic Hypotension Symptom Assessment (OHSA), and Clinical Global Impression of Severity (CGI-S).

FDA indicated that a single pivotal Phase 3 trial plus confirmatory evidence could be sufficient to support approval of ATH434 for MSA; Alterity expects its ATH434-201 Phase 2 trial dataset to provide the confirmatory evidence. FDA also stated the anticipated Phase 3 safety database size was reasonable. Alterity plans an open-label extension and remains on track to initiate Phase 3 trial activities by year-end 2026.