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FDA confirms Phase 3 trial plan for Alterity's ATH434 to treat Multiple System Atrophy

Company Fundamentals
07 Jul 2026
GlobeNewsWire
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Bullish
pluang ai news

Alterity Therapeutics received official FDA minutes confirming the design and pathway for a pivotal Phase 3 trial of ATH434, a drug candidate for Multiple System Atrophy (MSA). The FDA agreed that a single Phase 3 trial, supported by previous Phase 2 data, could be sufficient for approval. The trial will enroll about 200 patients treated with ATH434 or placebo for 12 months, with key efficacy and safety endpoints agreed upon. Alterity plans to start the Phase 3 trial by the end of 2026, aiming to provide a new treatment option for this rare, progressive neurodegenerative disease with no current cure.

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