YODA-KY (7829) YA-101 Granted Orphan Drug Designation by the EU EMA for the Treatment of Multiple System Atrophy
TAIPEI, January 14, 2026 — YODA-KY (7829) announced today (14th) that it has received notification from the European Medicines Agency (EMA) that its investigational drug, YA-101, has been granted Orphan Drug Designation (ODD) for the treatment of Multiple System Atrophy. Drugs granted orphan designation by the EMA may benefit from incentives such as tax credits for clinical trial costs or reductions in certain regulatory fees, in accordance with the regulations of EU member states. Upon eventual marketing approval, if the drug is the first approved therapy for this indication or demonstrates significant clinical superiority over existing treatments, it may be eligible for up to 10 years of market exclusivity.
YA-101 was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of multiple system atrophy (MSA) in July 2022 and received Fast Track Designation from the FDA in December 2025. In the same month, YA-101 was also designated as an orphan drug for MSA by Japan’s Ministry of Health, Labour and Welfare (MHLW). The recent Orphan Drug Designation by the European Medicines Agency (EMA) further underscores YA-101’s clinical potential in addressing a significant unmet medical need and supports the company’s global clinical development and market strategy.
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 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.
In addition, YODA-KY completed a cash capital increase on the 5th of this month, raising NT$920 million, which has been fully received. The capital increase is based on a record date of January 5, 2026. The proceeds will strengthen the company’s operating capital and support the continued advancement of clinical trials and R&D programs for YA-101 and other investigational drugs.
Jane Tseng, CEO of YODA-KY, stated: “YA-101 has consecutively received regulatory recognition in the U.S., Japan, and the EU, highlighting the company’s capabilities and commitment in international new drug development. With the completion of this month’s cash capital increase, we are fully committed to advancing clinical development and addressing the unmet medical needs of patients with neurodegenerative central nervous system disorders.”
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, Multiple System Atrophy (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.