Alterity Therapeutics Limited (NASDAQ:ATHE) stock is up during Tuesday's session as the biotechnology company announced an End-of-Phase 2 meeting with the U.S.
Food and Drug Administration (FDA) regarding its pivotal Phase 3 program for ATH434 in treating Multiple System Atrophy (MSA).
The FDA agreed on key elements of the proposed Phase 3 trial design, including the study population and dosing regimen, following ATH434's demonstration of a 48% slowing of disease progression compared to placebo in the Phase 2 study.
The pivotal Phase 3 trial activities are on track to initiate by year-end 2026.
"The successful outcome of the meeting is an important de-risking milestone and gives us confidence as we finalize the protocol and prepare to initiate trial activities by year-end 2026… I am confident that ATH434 is well-positioned to become a disease-modifying therapy for individuals living with MSA," said David Stamler, CEO of Alterity Therapeutics.
