Gallant has announced that the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has completed its review of the Reasonable Expectation of Effectiveness (RXE) technical section for its investigational new animal drug, sonruvetcel suspension for injection.
This therapy is a potential first-in-class, uterine-derived allogeneic mesenchymal stromal cell therapy for cats with refractory feline chronic gingivostomatitis (FCGS), a severe oral inflammatory disease for which current treatment options are limited.
The RXE technical section completion is a significant step forward in the conditional approval process. According to Gallant, this keeps the therapy on track for potential conditional FDA approval in early 2026. If approved, sonruvetcel could become the first FDA-approved, ready-to-use stem cell therapy in veterinary medicine.
FCGS often leads to severe oral pain and diminished quality of our feline friends. With few effective treatments available, many affected cats are ultimately euthanized. Gallant’s product uses cells sourced from healthy, specific-pathogen free, FDA-qualified feline donors and is manufactured following current Good Manufacturing Practice (cGMP) standards. The company states that potency is established specifically for FCGS.
“Completion of the RXE technical section marks a foundational milestone for Gallant’s uterine-derived platform of allogeneic mesenchymal stromal cell therapies—and the potential first ready-to-use stem cell therapy in veterinary medicine,” said Dr. Valentine Williams, Senior Vice President of Clinical Development and Strategy at Gallant.
“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. We are entering the regenerative medicine era—and proud to be leading the way.”
Gallant is developing additional ready-to-use stem cell therapies for both common and underserved conditions in cats and dogs. In addition to refractory FCGS, the company reports that clinical trials are ongoing or have been completed for feline osteoarthritis, chronic kidney disease, and canine conditions such as osteoarthritis and atopic dermatitis. For more information, visit https://www.gallant.com/.
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