FDA accepts target animal safety section for LOY-002, leaving manufacturing review before conditional approval

Loyal/LOY-002

The FDA's Center for Veterinary Medicine accepted the target animal safety section of Loyal's Expanded Conditional Approval application for LOY-002, completing two of three critical elements needed for approval.

• Safety evaluation included data from 400+ dogs at 1x, 3x and 5x intended doses with no clinically significant adverse events.
• FDA acceptance signals the agency finds data support that LOY-002 is likely effective and safe for extending healthy lifespan in senior dogs.
• Manufacturing review and clinical STAY trial data remain before full FDA approval; conditional approval pathway advances.