Dasher Neuroscience (思捷優達-KY) announced on the 14th that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead candidate, YA-101, for the treatment of Multiple System Atrophy (MSA).

Asset Profile & Incentives:

• Global Recognition: YA-101 now holds ODD status in the US, Japan, and the EU, and was granted FDA Fast Track Designation in December 2025.
• Commercial Protection: Upon approval, the EMA ODD provides 10 years of market exclusivity, alongside clinical trial tax credits and fee waivers.
• Mechanism of Action: YA-101 is a New Chemical Entity (NCE) designed to inhibit neuroinflammation and enhance neuroplasticity.
• Clinical Timeline: A global Phase II randomized, double-blind, placebo-controlled trial is currently underway in the US, Japan, and Taiwan, with enrollment expected to finish this year.
• Capital Strength: CEO Alice Yu-Feng Tseng confirmed that a NT$920 million private placement was completed on January 5, providing the necessary runway to finalize clinical development.

Resource: 思捷優達新藥YA-101 獲歐盟授予抗多重系統退化症的孤兒藥資格認定