“As we near the end of the calendar year, I am very proud of all we have accomplished in 2025, led by our compelling clinical results in Multiple System Atrophy, and I am excited about the prospect of delivering ATH434 to the MSA community,” said David Stamler, CEO. “During the recent quarter, we reported positive results from our trial in advanced MSA, published important neuroimaging findings from our natural history study, and completed our commercial assessment indicating a potential market opportunity of approximately USD$2.4 billion dollars. The totality of the data from our combined studies and interest from the medical and scientific community continues to give us great confidence in the potential of ATH434 as a first-in-class, disease-modifying therapy for MSA. We are actively engaging with the U.S. Food and Drug Administration on ATH434 to conduct a series of meetings to discuss emerging nonclinical and chemistry and manufacturing data required for Phase 3 conduct. Reaching agreement on these elements with the FDA is critical for ensuring a productive End-of-Phase 2 meeting to enable us to initiate a Phase 3 trial in MSA.”
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