First ready to use stem cell therapy achieves FDA “technical section complete”

Gallant, an animal health biotechnology company working on ready-to-use stem cell therapies for pets, announced the FDA’s Center for Veterinary Medicine (FDA-CVM) issued a complete letter for the Reasonable Expectation of Effectiveness technical section to support conditional approval of its ready-to-use stem cell therapy for refractory feline chronic gingivostomatitis (FCGS).

Friends Stock/stock.adobe.com

"This milestone represents a major leap forward in our mission to make stem cell therapies accessible to every pet in need," said Linda Black, DVM, PhD, CEO of Gallant, in an organizational release.¹ "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."

According to the release, the product under review is Gallant’s investigational new animal drug (INAD), sonruvetcel suspension for injection. This is potentially a first-in-class, uterine-derived allogeneic mesenchymal stromal cell therapy that is developed specifically for feline patients with refractory FCGs.¹ Feline patients with refractory FCGS suffer from severe oral pain as well as a reduced quality of life, but there are currently no therapeutic options available. Because of this, many of these cats are then euthanized.

Gallant’s cells are sourced from a healthy, specific-pathogen free, FDA-qualified feline donors and then manufactured under current Good Manufacturing Practice conditions. Gallant disclosed that the conditional approval of the product is targeted for early 2026, and if given the conditional approval, this could be the first FDA-conditionally approved and ready to use stem cell therapy in veterinary medicine.

"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 Valentine Williams, DVM, MS, DACVS (Equine), senior vice president of clinical development and strategy at Gallant, in the release.¹

"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. This success not only validates that vision but also demonstrates our ability to navigate the regulatory pathway for a pipeline of products that are leading the industry into the regenerative medicine era—an era focused on more than just managing clinical symptoms."

RELATED: Busting myths around stem cell therapy²

This therapy is in currently being reviewed for conditional approval and if granted, veterinarians will be able to begin prescribing and using the product in everyday practice for this ‘undeserved population of cats.’

In July of this year, Gallant raised $18 million in a Series B funding round to help develop and potentially commercialize its off the shelf stem cell therapies, including this one. Additional products in this new line of therapies include treatments for feline and canine osteoarthritis, canine atopic dermatitis, and feline chronic kidney disease, each of which will continue to be developed with funding.³

A survey Gallant conducted with over 800 veterinarians in the US found that of those surveyed, 56% are satisfied with the current therapies out there for canine osteoarthritis, with most agreeing that current treatments focus on managing symptoms instead of addressing the underlying disease.⁴ Of those surveyed, only 8% showed satisfaction in the current treatments out there for FCGS.

References

1. Gallant Achieves FDA "Technical Section Complete" for Reasonable Expectation of Effectiveness, Advancing First Ready-to-Use Stem Cell Therapy. News release. Gallant. September 23, 2025. Accessed September 23, 2025. https://prnmedia.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
2. 2.Windsor R. Busting myths around stem cell therapy. DVM 360. Published July 31, 2025. Accessed September 23, 2025. https://www.dvm360.com/view/busting-myths-around-stem-cell-therapy
3. Bautista-Alejandre A. Veterinary stem cell therapy advances toward FDA approval with $18M in funding. dvm360. Published July 8, 2025. Accessed September 23, 2025. https://www.dvm360.com/view/veterinary-stem-cell-therapy-advances-toward-fda-approval-with-18m-in-funding
4. Veterinarians agree: Current treatments manage symptoms; anticipate regenerative options—Gallant study.