PRESS RELEASE
AB SCIENCE ANNOUNCES THAT THE FDA HAS GRANTED THE STATUS OF MINOR USE IN MAJOR SPECIES DESIGNATION FOR MASIVET IN THE TREATMENT OF CANINE MAST CELL TUMORS
AB SCIENCE PRESENTS PERSPECTIVE OF THE ANIMAL HEALTH FRANCHISE
Paris, February 9, 2026, 6pm CET
AB Science SA (Euronext - FR0010557264 - AB) announced that the Food and Drug Administration (FDA) granted the status of Minor Use in Major Species (MUMS) for Masivet® in the treatment of canine mast cell tumors.
Masivet® is a targeted therapy that inhibits the juxtamembrane mutations of c-kit, which is the main driver of dog mast cell tumors.
The MUMS designation is similar to the status of "Orphan Drug" for human drugs. This makes the sponsor eligible for incentives to support the approval of the designated use. When a drug is designated for a particular intended use, the sponsor of the drug obtains seven years of exclusive marketing rights upon approval of the drug for the intended use (i.e., canine mast cell tumors). A sponsor of designated new animal drugs is also eligible to apply for grants to defray the cost of studies to support the approval of the designated intended use.
Masivet® is registered and commercialized in Europe and is profitable, but it is not yet registered in the USA.
"The MUMS status delivered by FDA is an encouragement to develop Masivet® in the USA" states Alain Moussy, CEO of AB Science.
AB Science intends to expand this profitable franchise. In the case of Masivet® approval in the USA, AB Science expects EBITDA generated from animal health to cover part of its fixed-cost structure and contribute to auto-financing and derisking of the company.
AB Science is also in discussion with various companies regarding distribution and commercialization agreements for European countries not yet covered (Norway, Denmark, Sweden, Finland, and Lithuania), LATAM (Brazil, Argentina, and Mexico), Asia (Japan and Taiwan), MENA regions, and South Africa.
The demand for Masivet is global, and AB Science intends to expand its business.
Masivet is safe and effective and responds satisfactorily to the demand for mast cell tumors. Pet owners and veterinarians showed great satisfaction with the treatment.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, which are often lethal with short-term survival or rare or refractory to previous lines of treatment.
AB Science has developed a proprietary portfolio of molecules, and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is being developed for human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. The company is headquartered in Paris, France and is listed on Euronext Paris (ticker: AB).
Further information is available on AB Science's website: www.ab-science.com.
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