Dasher Neuroscience-KY (7829) Progresses Phase II AI Drug for Multiple System Atrophy, Initiating International Licensing Steps
Dasher Neuroscience Holdings Inc. (hereinafter Dasher-KY, stock code: 7829), which focuses on developing novel central nervous system (CNS) drugs using artificial intelligence (AI), will exhibit its flagship drug, YA-101, at BIO Asia–Taiwan 2026 (Booth: M434). With its primary indication for Multiple System Atrophy (MSA), YA-101 is progressing smoothly through Phase II clinical trials. The company is actively seeking licensing partners to accelerate the clinical implementation of YA-101, aiming to benefit patients with neurodegenerative diseases and to establish it as a first-in-class drug for MSA.
Rare Disease MSA Phase II Clinical Trial Progresses Smoothly, Launching International Licensing
YA-101 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation (ODD) in the U.S., Japan, and the European Union (EU). These designations not only accelerate the FDA review and approval process but also grant 7 years of market exclusivity in the U.S. In Japan, the designation offers incentives, including extending the re-examination period to up to 10 years, securing its market exclusivity upon future commercialization. Notably, while the EU maintains very strict reviews for orphan drug status, once successfully launched as a breakthrough orphan drug, it will be granted up to 11 years of market exclusivity in the EU.
YA-101 is a New Chemical Entity (NCE) and a D-amino acid oxidase inhibitor (DAOI) that can inhibit inflammatory cytokines, primarily by reducing neuroinflammation and enhancing neuroplasticity to improve disease outcomes.
Jane Tseng, CEO of Dasher Neuroscience-KY, stated: “Currently, YA-101 is undergoing Phase II clinical trials for patients with multiple system atrophy, conducted concurrently across multiple clinical trial centers in the U.S., Japan, and Taiwan. At present, overall patient recruitment is progressing smoothly, and we have simultaneously initiated our steps toward international licensing.”
AI Parkinson’s Drug Expected to Launch Clinical Trials Next Year
In addition to the smooth clinical progress of the rare neurodegenerative disease MSA, Dasher-KY’s AI drug has been selected by the International Linked Clinical Trials (iLCT) program into its “Priority List for Parkinson’s Disease Clinical Development.” As the first drug from Taiwan to be selected, it has instantly leaped into the global Parkinson’s disease R&D spotlight, with the potential to receive clinical trial funding from the UK Parkinson’s research charity, Cure Parkinson’s, in the future.
Furthermore, Dasher-KY has signed a Memorandum of Understanding (MOU) with Helse Bergen HF, Haukeland University Hospital in Bergen, Norway. Both parties will engage in deep exchanges to jointly advance the AI drug into the HYDRA Phase III platform trial, which is expected to become Taiwan’s first new drug to enter a leading global platform trial for Parkinson’s disease.
At the same time, the company has also signed an MOU with the Shake It Up Australia Foundation and an agreement in principle with the Movement Disorders Society of Australia and New Zealand Clinical Trials Network (MDSANZ CTN). This is expected to attract international funding and clinical trial resources, accelerating the implementation of innovative therapies worldwide.
Currently, within Dasher-KY’s pipeline, preclinical research is also underway for neuro-related diseases such as Alzheimer’s disease and schizophrenia. Through this exhibition, the company hopes to exchange and form alliances with domestic and foreign licensing partners, medical institutions, and biotech industry peers, fully driving the global clinical development, registration, and commercialization of CNS AI drugs, and working together to allow patients with neurological diseases to access effective innovative therapies as early as possible.
About Dasher Neuroscience Holdings Inc.
Dasher Neuroscience-KY (7829) was listed on the Taiwan Emerging Stock Board on June 3, 2025. It is a biopharmaceutical company focused on using AI to accelerate CNS therapies.
The company’s flagship drug, YA-101, initially targets MSA and is currently in Phase II clinical trials. It has received U.S. FDA Fast Track Designation and ODD in the U.S., Japan, and the EU. Additionally, YA-102 for the treatment of Parkinson’s disease is under development, along with two preclinical pipeline candidates: YA-201 for Alzheimer’s disease and YA-301 for schizophrenia. Upholding its mission to solve unmet medical needs, the company focuses on providing innovative, safe, and effective therapeutic choices. For more information, please visit the company website: www.dasherneuroscience.com.