A groundbreaking stem cell therapy for cats has reached a major regulatory milestone, bringing the first FDA-approved ready-to-use treatment of its kind closer to veterinary clinics nationwide. Gallant, an animal health biotechnology company, announced that the U.S. Food and Drug Administration Center for Veterinary Medicine has completed the technical review for their revolutionary therapy targeting feline chronic gingivostomatitis (FCGS).
The therapy, called sonruvetcel suspension for injection, represents a potential first-in-class treatment for cats suffering from refractory FCGS, a debilitating condition that causes severe oral pain and dramatically reduces quality of life. Currently, no therapeutic options exist for this condition, often leaving euthanasia as the only option for affected cats.
Revolutionary Treatment Offers Hope for Suffering Cats
Feline chronic gingivostomatitis affects thousands of cats across the United States, causing excruciating mouth pain that makes eating and drinking difficult. The condition involves severe inflammation of the gums and mouth tissues, and traditional treatments have proven largely ineffective for refractory cases.
Gallant’s innovative approach uses uterine-derived allogeneic mesenchymal stromal cells sourced from healthy, specific-pathogen free, FDA-qualified feline donors. These cells are manufactured under current Good Manufacturing Practice conditions and have demonstrated potency specifically for FCGS treatment.
“This milestone represents a major leap forward in our mission to make stem cell therapies accessible to every pet in need,” said Dr. Linda Black, CEO of Gallant. “We’re pioneering FDA-approved regenerative therapies designed to be practical and transformative—readily available, delivered through a simple intravenous injection, and aimed at treating the root cause rather than just the symptoms.”
Breakthrough Marks New Era in Veterinary Medicine
The FDA’s completion of the Reasonable Expectation of Effectiveness (RXE) technical section represents a crucial step toward conditional approval, which is targeted for early 2026. If granted, this would make sonruvetcel the first FDA-approved ready-to-use stem cell therapy in veterinary medicine.
Dr. Valentine Williams, Senior Vice President of Clinical Development and Strategy at Gallant, emphasized the significance of this achievement: “For many of us at Gallant, pioneering a gold-standard regenerative medicine platform has been a career-long ambition, serving beloved pets and enriching the lives of those who care for them.”
The therapy’s design focuses on practical application in everyday veterinary practice. Unlike complex treatment protocols, sonruvetcel can be administered through a simple intravenous injection, making it accessible to veterinarians across the country without requiring specialized equipment or extensive training.
Conditional approval will allow veterinarians to begin prescribing and using the product in clinical practice for this underserved population of cats, providing hope where none previously existed. The therapy targets the root cause of the disease rather than merely managing symptoms, representing a fundamental shift in treatment approach.
Gallant is actively advancing a comprehensive pipeline of ready-to-use stem cell therapies addressing both prevalent and underserved conditions in cats and dogs. Beyond refractory FCGS, the company has ongoing or completed clinical trials for feline osteoarthritis, chronic kidney disease, and canine conditions including osteoarthritis and atopic dermatitis.
This regulatory milestone comes at a time when pet owners are increasingly seeking advanced treatment options for their beloved companions. As veterinary medicine continues to evolve, regenerative therapies like stem cell treatments represent the next frontier in providing comprehensive care for pets facing previously untreatable conditions.
The development signals a broader transformation in veterinary medicine, moving beyond traditional symptom management toward treatments that address underlying disease mechanisms. For cats suffering from FCGS and their devoted owners, this breakthrough offers genuine hope for improved quality of life and potentially life-saving intervention.