FDA CVM accepts reasonable expectation of effectiveness for LOY-002

Loyal/LOY-002

The FDA Center for Veterinary Medicine accepted Loyal's reasonable expectation of effectiveness (RXE) for LOY-002, its senior-dog lifespan extension drug. RXE is formal FDA acceptance that a drug can be developed and approved to achieve its intended therapeutic goal; for LOY-002, manufacturing and safety acceptance remain before conditional approval.

• RXE is formal FDA acceptance that a drug can be developed and approved; one of three primary requirements for conditional approval.
• Manufacturing approval and safety acceptance remain before market launch.
• Loyal anticipates completing all regulatory requirements by end of 2025, potentially bringing FDA-approved longevity drug to market within one year.