YD Bio Announces FDA Grant of INTERACT Meeting Request for YDB-LMSCEV-001, an Investigational Extracellular Vesicle Candidate for Dry Eye Disease
Globe Newswire•12/11/2026•16:30 ET
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Key Highlights
- ➤FDA grants YD Bio (YDES) INTERACT meeting request for YDB-LMSCEV-001
- ➤Written FDA feedback expected by January 4, 2027
- ➤FDA will address nine questions on manufacturing controls and animal-study design
- ➤YD Bio completed initial laboratory and mouse studies for dry eye disease
Expert Statements
Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio
“For a product class as new as extracellular vesicles, we believe the most useful time to hear from the FDA is before the clinical manufacturing process and before specifications are fixed”
Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio
“We appreciate CBER’s agreement to provide written feedback on YDB-LMSCEV-001, and we intend to use its responses to shape our manufacturing, potency and nonclinical plans as we work toward a pre-IND meeting.”
FDA agrees to provide written guidance by January 4, 2027, to support development of YDB-LMSCEV-001
TAIPEI, Taiwan, Nov. 12, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection and ophthalmologic innovations, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted its request for an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting.
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