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FDA approves key Phase 3 trial design for Alterity's ATH434 in treating Multiple System Atrophy

Market News
09 Jun 2026
GlobeNewsWire
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Bullish
pluang ai news

Alterity Therapeutics has secured FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy (MSA), a rare neurodegenerative disease. The FDA approved the study population, dosing regimen of 50 mg twice daily, and primary endpoint UMSARS Part I, following positive Phase 2 results showing 48% slowing of disease progression. The Phase 3 trial, involving about 200 patients, is set to start by the end of 2026 and aims to support a New Drug Application. This milestone reduces regulatory uncertainty and advances ATH434 as a potential disease-modifying therapy for MSA, which currently has no approved treatments.

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