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Alterity Therapeutics clears FDA Phase 2 hurdle, plans Phase 3 trial for MSA drug ATH434 by end of 2026

Company Fundamentals
30 Jul 2026
GlobeNewsWire
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Bullish
pluang ai news

Alterity Therapeutics announced FDA agreement on a clear regulatory pathway for its drug ATH434 to treat Multiple System Atrophy (MSA), a rare neurodegenerative disease. The FDA confirmed that a single pivotal Phase 3 trial plus confirmatory evidence from Phase 2 data could support drug approval. Alterity plans to start the Phase 3 trial by the end of 2026, enrolling about 200 patients. The company also received a A$3.98 million R&D tax refund and holds A$37.3 million in cash, supporting ongoing development and strategic funding discussions to maximize shareholder value.

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