FDA Aligns with Alterity on Pivotal Phase 3 Design for ATH434 in MSA, De-risking Development
ATHE sits 38% above its 52-week low of $2.66.
Summary
Alterity Therapeutics has achieved full alignment with the FDA on the design of its pivotal Phase 3 program for ATH434 in Multiple System Atrophy (MSA). The FDA agreed on the study population, 50mg twice-daily dosing regimen, treatment duration, and the UMSARS Part I as the primary endpoint, which showed 48% slowing of disease progression in Phase 2. This is a critical de-risking milestone, substantially reducing uncertainty for the final stage of clinical development for a disease with no approved therapy. This follows earlier positive FDA feedback on the Phase 3 plan and CMC elements. Phase 3 trial activities are expected to initiate by year-end 2026.
At the time of this announcement, ATHE was trading at $3.66 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $64.4M. The 52-week trading range was $2.66 to $7.00. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.