Alterity Therapeutics Receives Positive FDA Feedback Following A Type C Meeting Regarding Its Planned Phase 3 Development Program For ATH434 In Multiple System Atrophy, A Rare, Rapidly Progressive Neurodegenerative Disease With No Approved Disease-Modifying Treatments

This second Type C Meeting builds on Alterity's recent regulatory interactions with the FDA and represents a further step towards readiness for the planned Phase 3 pivotal trial in MSA. Alterity received written feedback supporting its plans related to the chemistry, manufacturing, and control (CMC) elements of the program. The first Type C Meeting, which was announced in March, related to clinical pharmacology and non-clinical development aspects of the program.

"Confirming alignment with the FDA on the chemistry and manufacturing of ATH434 represents another critical step toward initiation of our Phase 3 program," said David Stamler, M.D., Chief Executive Officer of Alterity. "The FDA endorsed our plans related to the manufacture and testing of ATH434 for use in our Phase 3 trial and ultimately for commercialization, if approved. We continue to advance ATH434 through the necessary steps to initiate our pivotal development program, and we look forward to finalizing our plans with the FDA at an End-of-Phase 2 meeting that remains on track for mid-year 2026."