Gallant achieves drug approval milestone

Gallant, an animal health biotechnology company, announced earlier this week that it has made a massive advancement in the FDA conditional approval process for its lead therapy targeting refractory feline chronic gingivostomatitis (FCGS). According to the release, the FDA Center for Veterinary Medicine (FDA-CVM) issued a “Technical Section Complete letter for Target Animal Safety. By receiving this, the FDA determined that Gallant’s data support the 365-day safety requirement for stem cell therapy.

"Achieving TAS technical section completion means the successful demonstration of 365-day safety. Unlike most TAS studies conducted for pharmaceutical drugs in healthy animals, this study was conducted in client-owned cats with refractory FCGS, establishing both short- and long-term safety in this critical population. This represents another foundational milestone for Gallant's uterine-derived platform of allogeneic mesenchymal stromal cell therapies—and the potential first off-the-shelf cell therapy in veterinary medicine," said Valentine Williams, DVM, MS, DACVS, senior vice president of Clinical Development and Strategy at Gallant.

"With both reasonable expectation of effectiveness and target animal safety complete, the clinical relevance for conditional approval is established. We are moving rapidly into the next phase of launch planning to bring practitioners and pet parents a regenerative medicine solution for their loved ones, where before there was no hope. It's inspiring to see cats regain their quality of life after treatment with a product backed by proven safety. There is no greater career satisfaction."

The product currently under FDA review is Gallant’s sonruvetcel injectable suspension, a possible first-in-class uterine-derived allogenic mesenchymal stromal cell therapy (UMSC) for feline patients with refractory FCGS. The drug is sourced from healthy and specific-pathogen free feline donors that are FDA-qualified. The therapies are manufactured under current Good Manufacturing Practice (cGMP) conditions. Currently, the product is on track to receive FDA condition approval in early 2026.

The UMSC therapy for refractory FCGS received the “Technical Section Complete” for Reasonable Expectation of Effectiveness in September 2025.

"Safety is always our first and highest priority in developing new products for pets. The FDA's alignment on the 365-day safety data for sonruvetcel is not only validation for potentially the first off-the-shelf cell therapy in pets, but also validation for our entire platform of products in development," said Linda Black, DVM, PhD, CEO of Gallant. "We are one step closer to bringing a first-in-class therapy to veterinary medicine and a pipeline of products that target a pet's underlying disease, not just symptoms."

A study conducted by Gallant that recently was published in the Journal of Feline Medicine and Surgery found that within the 46 cats in the study, 75% of the subjects that were treated demonstrated a clinically relevant improvement in their quality of life by day 0, almost half experienced measurable improvements in oral lesions, and all subjects had no serious treatment-related adverse events.²

References

1. FDA Completes Safety for Gallant's First Ready-to-Use Stem Cell Therapy for Refractory FCGS. News release. Gallant. November 10, 2025. Accessed November 12, 2025. https://prnmedia.prnewswire.com/news-releases/fda-completes-safety-for-gallants-first-ready-to-use-stem-cell-therapy-for-refractory-fcgs-302610213.html
2. Williams V, Schneider JL, Parrish RS, et al. EXPRESS: Clinical field study evaluating the safety and efficacy of allogeneic uterine-derived mesenchymal stem cells for refractory feline chronic gingivostomatitis (FCGS). Journal of Feline Medicine and Surgery. 2025;0(ja). doi:10.1177/1098612X251385852