StoryRegulatory
YouthBio receives positive FDA INTERACT feedback for YB002 Alzheimer's gene therapy
YouthBio announced that the FDA confirmed its preclinical data support YB002's bioactivity and the company's proposed first-in-human clinical trial during an INTERACT meeting. The FDA guidance establishes a clear regulatory path forward, with YouthBio focusing on CMC manufacturing optimization and pilot toxicology studies to support a pre-IND meeting.