FDA grants IND clearance for YOLT-101, first in vivo base editor for cardiovascular disease in the U.S.

YolTech Therapeutics/YOLT-101

The FDA approved YolTech's IND application for YOLT-101 in June 2025, enabling the first in vivo base-editing therapy for familial hypercholesterolemia to enter U.S. clinical testing. The approval followed the company's earlier NMPA authorization in China.

• FDA IND clearance on June 6, 2025.
• YOLT-101 targets PCSK9 gene disruption to lower LDL cholesterol with a single intravenous dose.
• First in vivo base editor for cardiovascular disease to advance in U.S. trials.