Boo, a whippet, is enrolled at the Animal Hospital of Dauphin County (AHDC) in Harrisburg, PA, for the STAY study, the pivotal clinical trial for the life-extension drug LOY-002. Photo courtesy Loyal Loyal, a clinical-stage animal health company focused on canine longevity, announced that the U.S. Food and Drug Administration (FDA)’s Center for Veterinary Medicine has accepted the Reasonable Expectation of Effectiveness (RXE) section of its conditional approval application for LOY-002. The drug is designed to support healthy aging in senior dogs, building on the company’s earlier RXE acceptance for a longevity drug aimed at large-breed dogs. Additionally, the company has secured a $22 million B-2 funding round led by Valor Equity Partners and Collaborative Fund, increasing its total investment to more than $150 million. LOY-002, a daily flavored tablet for dogs aged 10 and older weighing at least 14 pounds, targets metabolic dysfunction to help mitigate age-related diseases. The FDA’s acceptance of RXE moves the company closer to an Expanded Conditional Approval (XCA), which it expects to complete by late 2025. Meanwhile, the animal health company continues its STAY study, a large-scale clinical trial evaluating LOY-002’s efficacy. Launched in December 2023, the trial will run for approximately four years and enroll more than 1,000 dogs across 70 veterinary clinics. The recent funding round will support Loyal’s efforts to bring LOY-002 to market while advancing its broader pipeline, including LOY-001 and LOY-003, which focus on extending the lifespan of large-breed dogs. For more information, visit Loyal’s website.
