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.

• Dates: 16 – 19 July 2026
• Location: Taipei Nangang Exhibition Center
• Booth: No. M434
• Event Link: Exhibitor Profile

• Dates: 22 – 25 June 2026
• Location: San Diego Convention Center, San Diego, USA
• Booth Location: No. 2621, Taiwan Pavilion
• Event Link: https://convention.bio.org

Program Details & Links

• Panel (“From Rules to Results – Can Europe Keep Up in the Global Biotech Race?”): https://www.biocap-europe.com/en/program/programme-overview#eventdate–From-Rules-to-Results-%E2%80%93-Can-Europe-Keep-Up-in-the-Global-Biotech-Race%3F–0c3c91db-843a-4fae-9031-774b12c4c291
• SPARK Europe Showcase: https://www.biocap-europe.com/en/program/programme-overview#eventdate–SPARK-Europe-Showcase–668cf11a-4cb4-486a-9e0c-cbfd6f9ade17

Dasher Neuroscience proudly participated in the World Parkinson Congress 2026 in Phoenix, joining the global Parkinson’s disease community for a week of scientific exchange, collaboration, and meaningful dialogue.

At our exhibition booth, we were pleased to engage with researchers, clinicians, advocacy groups, patients, families, and industry partners, and to share our latest progress in neurodegenerative disease research and therapeutic development. We sincerely thank everyone who visited our booth and took the time to exchange ideas and insights with our team.

A key highlight of the week was our hosted Cocktail Social, featuring a distinguished speaker program. We extend our sincere thanks to all speakers for sharing their perspectives and experiences:

Clyde Campbell, Founder of the Shake It Up Australia Foundation

Group photo with the MUFG team

Following a rigorous evaluation by a committee of over 25 top international Parkinson’s experts, Dasher Neuroscience’s AI drug for neurodegenerative diseases was selected for the iLCT program, a joint initiative by the UK Parkinson’s research charity Cure Parkinson’s and the US-based Van Andel Institute (VAI). Now officially included in the Priority List for Parkinson’s disease clinical development, the drug is poised to potentially receive clinical trial funding from Cure Parkinson’s in the future.

Since 2012, the iLCT program has invested £10.3 million (approximately NT$438 million) to support the development of various Parkinson’s therapies and diagnostics, recruiting over 4,700 Parkinson’s patients globally for related clinical trials. The program has completed 21 Parkinson’s clinical trials, with another 20 currently underway.

Being selected for iLCT Parkinson’s priority list highlights the novelty, therapeutic potential, and R&D capabilities of its AI-developed therapy for neurodegenerative diseases, while also placing the company on the global Parkinson’s research map.

Following this milestone, Dasher Neuroscience has initiated strategic collaborations with the Shake It Up Australia Foundation and the Movement Disorders Society of Australia and New Zealand Clinical Trials Network (MDSANZ CTN). Through this partnership, the Shake It Up Australia Foundation is expected to provide funding support for Dasher Neuroscience’s planned clinical trials in Australia.

Jane Tseng, CEO of Dasher Neuroscience, stated that the Shake It Up Australia Foundation is the largest non-governmental organization funding Parkinson’s research in Australia. The foundation collaborates with the Michael J. Fox Foundation (MJFF), the world’s largest private funder of Parkinson’s research, to advance promising Parkinson’s therapies into clinical trials. To date, the Shake It Up Australia Foundation has provided funding to 23 research institutions and supported up to 79 research projects in Australia, with total grants exceeding AU$30 million (approximately NT$680 million).

Moreover, through close collaboration with the MDSANZ CTN, Dasher Neuroscience is expected to leverage its extensive network of hospitals and research centers across Australia and New Zealand. This will facilitate large-scale, cross-regional matching of patient and physician resources, enhance patients’ access to clinical trials for movement disorders, and accelerate trial execution.

Jane Tseng noted that the company’s AI-developed therapy for neurodegenerative diseases has consecutively received recognition and support from iLCT, the Shake It Up Australia Foundation, and the Movement Disorders Society of Australia and New Zealand Clinical Trials Network (MDSANZ CTN). This strong backing will significantly help the company connect with leading Parkinson’s disease experts worldwide and accelerate the implementation of clinical trials at prominent medical centers across multiple countries. At the same time, it reflects Taiwan’s emergence into the global first-tier of Parkinson’s drug development.

About YODA Pharmaceuticals Inc. (YODA-KY)

YODA–KY (7829), listed on the Emerging Stock Board on June 3, 2025, is a biopharmaceutical company focused on AI-driven drug discovery and the development of therapies for CNS disorders.

The company’s flagship drug, YA-101, is initially targeting multiple system atrophy (MSA) and is currently in Phase II clinical trials. YA-101 has received Fast Track Designation from the U.S. FDA and Orphan Drug Designation (ODD) in the U.S., Japan, and the EU. Additionally, YA-102,  for Parkinson’s disease, is under development. The company is also advancing two preclinical drug candidates: YA-201 for Alzheimer’s disease and YA-301 for schizophrenia.

Committed to addressing significant unmet medical needs, YODA–KY focuses on providing innovative, safe, and effective therapeutic solutions. For more information, please visit: www.dasherneuroscience.com.

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.