Is your cat suffering from severe oral pain with no effective treatment options? Many cat owners face this difficult reality with Feline Chronic Gingivostomatitis (FCGS). A new development from Gallant may offer hope.
A Major Step Forward in Veterinary Medicine
Gallant, an animal health biotechnology company, has achieved a significant regulatory milestone. The U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has issued a complete letter for the Reasonable Expectation of Effectiveness (RXE) technical section for Gallant’s first ready-to-use stem cell therapy. This is a key step toward conditional approval.
This achievement keeps the therapy on track for conditional FDA approval in early 2026. It could become the first FDA-approved ready-to-use stem cell therapy in veterinary medicine.
What is Sonruvetcel?
Sonruvetcel is a potential first-in-class stem cell therapy for cats with refractory FCGS. It is a uterine-derived allogeneic mesenchymal stromal cell therapy.
| Feature | Description |
|---|---|
| Product Name | sonruvetcel suspension for injection |
| Classification | Investigational new animal drug (INAD) |
| Type | Uterine-derived allogeneic mesenchymal stromal cell therapy |
| Target | Cats with refractory feline chronic gingivostomatitis (FCGS) |
| Administration | Simple intravenous injection |
The Problem of Feline Chronic Gingivostomatitis (FCGS)
FCGS is a debilitating condition in cats. It causes severe oral pain and a reduced quality of life.
Currently, there are no therapeutic options available for refractory FCGS. This often leads to the difficult decision of euthanasia.
A New Era of Regenerative Medicine
Gallant’s therapy is designed to be a practical and transformative solution. It is readily available and delivered through a simple intravenous injection.
“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.
Gallant is also working on other stem cell therapies for pets. Clinical trials are ongoing or have been completed for feline osteoarthritis, chronic kidney disease, and canine diseases such as osteoarthritis and atopic dermatitis.
The Path to Approval
The therapy is being reviewed by the FDA-CVM for conditional approval. This would allow earlier access to the therapy for cats with no other treatment options.
If granted, veterinarians will be able to prescribe and use the product in their daily practice. This will provide a much-needed option for this underserved population of cats.
Looking Ahead
Gallant is at the forefront of a new era in veterinary medicine. Their work in regenerative medicine has the potential to change the lives of pets and their owners.
With a pipeline of ready-to-use stem cell therapies, Gallant is focused on treating the root cause of diseases, not just the symptoms. This new approach offers hope for many pets with chronic and debilitating conditions.
Reference:
[1] Gallant. (2025, September 23). Gallant Achieves FDA “Technical Section Complete” for Reasonable Expectation of Effectiveness, Advancing First Ready-to-Use Stem Cell Therapy [Press release]. PR Newswire. https://www.prnewswire.com/news-releases/gallant-achieves-fda-technical-section-complete-for-reasonable-expectation-of-effectiveness-advancing-first-ready-to-use-stem-cell-therapy-302563870.html
