Dasher Neuroscience-KY announced yesterday (22nd) that its subsidiary’s drug candidate, YA-101, for the treatment of Multiple System Atrophy (MSA), has been granted Fast Track Designation by the US FDA. This status is expected to expedite communication with the FDA and streamline the development process.

YA-101 is a New Chemical Entity (NCE) designed to inhibit neuroinflammation and enhance neuroplasticity. It previously received Orphan Drug Designation (ODD) in 2022. Following a successful Phase I trial in Australia in 2024, the drug is currently in a randomized, double-blind, placebo-controlled Phase II trial across centers in the US, Japan, and Taiwan. Enrollment is expected to conclude in 2026.

CEO Tsen Yu-feng emphasized that there are currently no FDA-approved treatments for MSA, a fatal neurodegenerative disease affecting the autonomic nervous system. With a prevalence of 5 per 100,000—including up to 50,000 patients in the US—YA-101 represents a significant unmet medical need.

Resource: 思捷優達-KY新藥YA-101，美FDA授予治多重系統退化症「快速審查認定」