YODA-KY (7829) New Drug YA-101 Granted US FDA “Fast Track Designation” for the Treatment of Multiple System Atrophy
TAIPEI, December 22, 2025 —YODA-KY (7829) announced today (22nd) that its subsidiary’s new drug YA-101 for the treatment of Multiple System Atrophy (MSA) has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation allows for more frequent consultations and written communications with the FDA once the ongoing Phase II clinical trial of YA-101 is completed and results are compiled. It is expected to provide more timely guidance on subsequent clinical trial design and development plans, thereby reducing redundant communication and administrative delays and improving overall development efficiency. However, the designation itself does not alter the design or timeline of the current Phase II trial, and actual development progress will depend on future clinical trial results and regulatory review outcomes. If relevant conditions are met in the future, the company may apply to the FDA for Accelerated Approval and Priority Review to shorten review and market entry timelines. Additionally, under the Rolling Review mechanism, completed sections of the New Drug Application (NDA) can be submitted to the FDA for review before the full application is complete, helping expedite the overall drug approval process.
YA-101 is a New Chemical Entity (NCE) specifically designed to treat neurodegenerative diseases, primarily by inhibiting neuroinflammation and enhancing neuroplasticity to improve disease outcomes. The drug received Orphan Drug Designation (ODD) from the US FDA for Multiple System Atrophy in 2022 and completed its Phase I clinical trial in Australia among healthy adult subjects in 2024. Currently, YA-101 is undergoing Phase II clinical trials for patients with MSA. The study is randomized, double-blind, placebo-controlled, and conducted simultaneously across multiple clinical sites in the United States, Japan, and Taiwan. According to the trial plan, full subject enrollment is expected to be completed in 2026.
Jane Tseng, CEO of YODA-KY, stated: “Receiving FDA Fast Track Designation for YA-101 is a major encouragement for our R&D team. It facilitates closer communication and discussion with the FDA, accelerating the overall drug approval process. Currently, there are no FDA-approved therapies for MSA. YA-101 has the potential to improve patients’ lives truly. This designation strengthens our focus on advancing the program, bringing hope to patients while demonstrating the company’s continued growth and capabilities.”
About Multiple System Atrophy (MSA)
Multiple System Atrophy (MSA) is a rare, rapidly progressive, and fatal neurodegenerative disease that affects the autonomic nervous system and leads to a decline in motor function. Patients frequently experience severe orthostatic hypotension, urinary dysfunction, unsteady gait, ataxia, speech impairment, and cognitive decline, which severely impact their quality of life. Current treatment approaches primarily focus on symptomatic relief, such as dopamine replacement therapy and autonomic nervous system modulators; however, their efficacy is limited, and there are currently no approved drugs on the market for MSA. The global prevalence of MSA is approximately 5 cases per 100,000 people. The number of patients in the United States ranges from approximately 15,000 to 50,000, while Japan has about 12,000 patients, representing a prevalence rate higher than the global average.
About YODA Pharmaceuticals Inc. (YODA-KY)
YODA-KY (7829), listed on the Emerging Stock Board on June 3, 2025, is a biopharmaceutical company dedicated to AI-driven drug discovery, with a primary focus on treatments for central nervous system (CNS) disorders. Its flagship drug candidate, YA-101, is currently in Phase II clinical trials for its lead indication, MSA. Driven by a mission to address significant unmet medical needs, YODA -KY is committed to providing innovative, safe, and effective therapeutic solutions. For more information, please visit the company’s website at www.dasherneuroscience.com.