Alterity Therapeutics received positive regulatory feedback following a second Type C meeting with the U.S. Food and Drug Administration on its planned Phase 3 development program for ATH434 in multiple system atrophy.
The FDA provided written feedback supporting the company’s chemistry, manufacturing and control elements, and the company says that alignment supports readiness to initiate a pivotal Phase 3 trial while manufacturing scale-up progresses in parallel.
The second Type C meeting builds on an earlier interaction announced in March that addressed clinical pharmacology and non-clinical development. The company said an End-of-Phase 2 meeting with the FDA remains on track for mid-2026.
ATH434 demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 trial and has reported positive open-label data in participants with advanced multiple system atrophy. Alterity Therapeutics is based in Melbourne, Australia, and San Francisco, California.
