USFDAJul 7, 2026, 07:06 AM
Alterity Therapeutics gets FDA nod for single Phase 3 ATH434 trial
AI Summary
Alterity Therapeutics announced it received official FDA minutes confirming the outcomes of its End-of-Phase 2 meeting for ATH434 in Multiple System Atrophy (MSA). The FDA agreed that a single pivotal Phase 3 trial, supported by confirmatory evidence from the Phase 2 trial, could support approval. The company remains on track to initiate Phase 3 trial activities by year-end 2026, with the study expected to enroll approximately 200 patients.
Key Highlights
- FDA minutes confirmed End-of-Phase 2 meeting outcomes for ATH434 in MSA.
- FDA agreed to a single pivotal Phase 3 trial for ATH434 in MSA.
- Phase 3 trial activities are on track to initiate by year-end 2026.
- Phase 3 study expected to enroll approximately 200 patients.
- Patients will be randomized 1:1 and treated for 12 months.
- Data from ATH434-201 Phase 2 trial will provide confirmatory evidence.
- ATH434 has Fast Track and Orphan Drug Designation for MSA.
Price Impact
More from ATHE