Alterity Therapeutics Limited (ATHE) on Monday said it received positive feedback from the U.S. Food and Drug Administration following a Type C meeting regarding its planned Phase 3 program for ATH434 in Multiple System Atrophy (MSA).
MSA is a rare neurodegenerative disease with no approved disease-modifying treatments.
Alterity said the FDA supported the company's plans for chemistry, manufacturing, and control (CMC) aspects of the program.
"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," said David Stamler, Chief Executive Officer of Alterity.
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