Agreement establishes first ultra-low temperature cold chain in veterinary medicine ahead of anticipated potential first FDA-approved, off-the-shelf stem cell therapy
SAN DIEGO, Feb. 27, 2026 /PRNewswire/ — Gallant, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced a landmark fulfillment agreement with MWI Animal Health (MWI), part of global healthcare company Cencora, to create the first-ever ultra-low temperature cold chain for veterinary medicine. This comes as Gallant advances toward delivering the potential first-ever FDA-approved off-the-shelf veterinary stem cell therapy, pending conditional approval by the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM).
Together, the companies are laying the foundation for a new category of veterinary care.
The first expected product from Gallant’s pipeline is sonruvetcel injectable suspension—a potential first-in-class, uterine-derived allogeneic mesenchymal stromal cell (MSC) therapy for cats with refractory feline chronic gingivostomatitis (rFCGS). Partnership with MWI will enable reliable delivery of veterinary stem cell therapies requiring storage at -80°C.
“Breakthrough science only matters if we can safely and reliably put it into the hands of veterinary professionals,” said Dr. Linda Black, DVM, Ph.D., CEO of Gallant. “With MWI, we are pairing regenerative medicine innovation with world class supply chain management. This partnership helps ensure that, once approved, veterinarians can conveniently access an FDA-regulated, off-the-shelf stem cell therapy with confidence in its quality and integrity.”
“This partnership demonstrates how distribution innovation can unlock clinical innovation,” said Julia Loew, CCO at MWI Animal Health. “Stem cell therapies require precision handling. By investing in ultra-low temperature logistics tailored to veterinary practice, we are ensuring that this category of innovation can be delivered to clinics in the exact state intended, ready for safe and effective use.”
Under the agreement, MWI will develop and deploy a scalable, ultra-low temperature fulfillment model. It will support nationwide availability through overnight shipping from MWI’s Edwardsville, Kansas, distribution center, helping to ensure access for clinics across the continental United States and in noncontiguous U.S. markets, including Alaska, Hawaii, and Puerto Rico.
The companies expect the partnership to serve as a model by establishing infrastructure that can support Gallant’s broader pipeline of disease-modifying therapies targeting inflammatory and degenerative conditions in companion animals.
Expanding the Spectrum of Care
Recent survey data conducted by Gallant, in collaboration with the American Animal Hospital Association (AAHA), found that nearly 95% of veterinary professionals believe stem cell therapy will become a standard treatment option within the next decade. 79% say they are likely to use or recommend stem cell therapy in the future, and 93% report they would be more likely to offer regenerative therapies in-house if they were off-the-shelf and delivered through a simple IV protocol.
The Gallant–MWI partnership directly addresses veterinary professionals’ expectations and practice needs by pairing an anticipated FDA-regulated, donor-derived stem cell therapy with a clinic-friendly fulfillment model.
About Gallant
Gallant is an animal health biotechnology company creating a new category of veterinary medicine with a pipeline of off-the-shelf, ready-to-use stem cell therapies targeting the root causes of disease in pets. Led by pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing and commercialization, Gallant is making regenerative medicine accessible to everyday practice. Learn more at www.gallant.com.
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Sonruvetcel is an investigational new animal drug and has not yet received FDA conditional approval. Availability is pending regulatory review.
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SOURCE Gallant
