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Alterity Therapeutics Limited (ASX:ATH)

ALERT: Price-sensitive ASX Announcement for ATH
Current share price for ATH : $0.660 0.651 (7,233.33%)+
Announcement
Release
9 Jun 2026 9:01AM
Price at Release
$0.009
Full Release
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Summary
Alterity Therapeutics Limited announced that they have achieved alignment with the U.S. FDA on the key elements of their Phase 3 clinical trial for ATH434, a treatment for Multiple System Atrophy (MSA). The FDA has agreed on the trial's design, including the study population, treatment duration, and a primary endpoint using the 11-item UMSARS Part I rating scale. The Phase 3 trial is scheduled to begin by the end of 2026 and aims to support a New Drug Application (NDA) in the United States. ATH434 has previously received Fast Track and Orphan Drug Designations, recognizing its potential in addressing the unmet medical need for MSA. The successful Phase 2 trials demonstrated significant efficacy and safety, reinforcing confidence in ATH434 as a disease-modifying therapy for MSA.
Key Points
  • Alterity Therapeutics aligns with FDA on Phase 3 program for ATH434.
  • Phase 3 trial designed for Multiple System Atrophy (MSA).
  • FDA agrees on study design, dosage, and endpoints.
  • ATH434 has Fast Track and Orphan Drug Designations.
  • Phase 3 trial to initiate by the end of 2026.
  • Significant efficacy observed in Phase 2 trials.
  • ATH434 shown to reduce a-synuclein pathology.
  • Trial aims to support a potential New Drug Application (NDA).
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.