FDA Grants MUMS Status to Masivet® for Dog Mast Cell Tumor Treatment

PRESS RELEASE

AB SCIENCE ANNOUNCES THAT THE FDA HAS GRANTED REGULATORY STATUS “MINOR USE IN MAJOR SPECIES” (MUMS) AT MASIVET IN THE TREATMENT OF MAST CELL TUMORS IN DOGS

AB SCIENCE PRESENTS THE PROSPECTS OF ITS ANIMAL FRANCHISE

Paris, February 9, 2026, 6:00 p.m.

AB Science SA (Euronext – FR0010557264 – AB) announces that the American Food and Drug Administration (FDA) has granted the status of Minor Use in Major Species (MUMS) to Masivet® in the treatment of mast cell tumors in dogs.

Masivet® is a targeted treatment that inhibits juxtamembrane mutations in the c-kit gene, the main factor responsible for mast cell tumors in dogs.

The MUMS designation is similar to “orphan drug” status for medicines for human use. It allows the developer to benefit from incentives to support approval of the designated use. When a drug is designated for a particular use, the drug sponsor obtains seven years of exclusive marketing rights upon approval of the drug for the intended use (in this case canine mast cell tumors). The sponsor of a designated new veterinary drug may also apply for grants to cover the cost of studies to support approval of the designated intended use.

Masivet® is registered and marketed in Europe and is profitable, but it is not yet registered in the United States.

« The MUMS status granted by the FDA is an encouragement to develop Masivet® in the United States “, said Alain Moussy, CEO of AB Science.

AB Science intends to expand this profitable franchise. If Masivet® is approved in the United States, AB Science expects that the EBITDA generated from the sale of the product will cover part of its fixed cost structure and contribute to the company’s self-financing and risk reduction.

AB Science is also in discussions with various partners regarding distribution and marketing agreements in European countries not yet covered (Norway, Denmark, Sweden, Finland and Lithuania), Latin America (Brazil, Argentina and Mexico), Asia (Japan and Taiwan), MENA regions and South Africa.

Demand for Masivet is global and AB Science intends to expand this business.

Masivet is safe and effective and satisfactorily addresses the demand for mast cell tumors. Pet owners and veterinarians have been very satisfied 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 decisive in cell signaling. Our programs only target pathologies with a high medical need, often fatal with a low survival rate, rare or resistant to first line treatment.
AB Science has developed its own portfolio of molecules and AB Science’s flagship molecule, masitinib, has already been registered in veterinary medicine and is being developed in humans in oncology, in neurodegenerative diseases, in infLMAmatory diseases and in viral diseases. The Company is headquartered in Paris and is listed on Euronext Paris (Ticker: AB).

More information about the Company on the website: www.ab-science.com

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