Alterity Therapeutics received positive feedback from the U.S. Food and Drug Administration following a Type C meeting on its planned Phase 3 development program for ATH434 in Multiple System Atrophy.
The FDA provided written feedback supporting the company’s clinical pharmacology and non-clinical development elements for the program. Alterity said it will seek formal agreement with the FDA on Chemistry, Manufacturing, and Controls and on the Phase 3 trial design, and that an End-of-Phase 2 meeting remains on track for mid-year 2026.
The company is preparing to initiate a Phase 3 pivotal trial for MSA and has identified ATH434 as its lead asset. Alterity claims ATH434 demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial and reports additional positive data from an open-label Phase 2 trial in advanced MSA.
The company is based in Melbourne, Australia and San Francisco, California, and is listed on ASX (ATH) and NASDAQ (ATHE).
