AB Science 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
MWN-AI** Summary
AB Science SA, a pharmaceutical company based in Paris, recently announced that the U.S. Food and Drug Administration (FDA) has granted Minor Use in Major Species (MUMS) designation for its product Masivet® for the treatment of canine mast cell tumors. This designation, akin to the "Orphan Drug" status in human pharmaceuticals, provides significant incentives for the approval process of the therapy. Specifically, it grants the sponsor seven years of exclusive marketing rights once the drug is approved and eligibility for grants to help cover study costs.
Masivet® is a targeted therapy designed to inhibit juxtamembrane mutations of c-kit, a key driver of mast cell tumors in dogs. While already registered and profitable in Europe, Masivet® has yet to receive approval in the U.S. AB Science's CEO, Alain Moussy, emphasized that the MUMS recognition is a significant step toward developing Masivet® in the American market, with aspirations that its approval could help offset fixed costs and enable self-funding and risk reduction for the company.
Furthermore, AB Science is exploring distribution and commercialization partnerships for additional markets in Europe (including Norway, Denmark, and Sweden), Latin America, Asia (notably Japan and Taiwan), the MENA region, and South Africa, reflecting the global demand for Masivet®. With strong satisfaction from pet owners and veterinarians regarding Masivet®'s safety and effectiveness, AB Science aims to expand its animal health portfolio significantly.
Founded in 2001, AB Science specializes in developing protein kinase inhibitors targeting high unmet medical needs, with its lead compound, masitinib, already registered for veterinary use and under development for human applications in various medical fields.
MWN-AI** Analysis
AB Science's recent announcement regarding the FDA's granting of Minor Use in Major Species (MUMS) status for Masivet® marks a significant milestone that could expand its growth in the competitive animal health market. This designation not only reinforces the credibility of Masivet® as a targeted treatment for canine mast cell tumors but also opens avenues for potential financial benefits, including seven years of exclusive marketing rights and eligibility for grants that could offset development costs.
Masivet's successful commercialization in Europe underscores the product's efficacy and the strong demand from veterinarians and pet owners. As the company aims for regulatory approval in the U.S. market, there is notable potential for substantial revenue generation. If approved, the EBITDA generated from Masivet® is anticipated to assist in reducing the company's fixed cost structure, potentially leading to an overall derisking of the firm.
Investors should closely monitor AB Science's strategies regarding distribution agreements, particularly as the company targets underserved regions in Europe and emerging markets in LATAM and Asia. These moves could significantly enhance the market reach and drive revenue growth, given the rising global demand for effective veterinary treatments.
Moreover, investors should be aware of the inherent risks associated with product development and regulatory approvals that may impact AB Science’s future performance. While the MUMS designation brings optimism, the path to successful commercialization in the U.S. remains contingent on various factors, including clinical trial results and market competition.
Overall, AB Science demonstrates a robust growth trajectory and prudent risk management strategies. Investors with an interest in biotechnology and animal health sectors should consider AB Science as a potential addition to their portfolios, while remaining vigilant to the market's inherent uncertainties.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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.
Forward-looking Statements - AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions, and expectations regarding financial results, events, operations, future services, product development, and their potential or future performance.
These forward-looking statements can often be identified by the words "expect", "anticipate", "believe", "intend", "estimate" or "plan" as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science, which may imply that results and actual events significantly differ from those expressed, induced, or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the product development of the Company, which may not be successful, or to the marketing authorizations granted by competent authorities, or, more generally, any factors that may affect the marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.
For additional information, please contact:
AB Science
Financial Communication & Media Relations
Attachment
FAQ**
How does the Minor Use in Major Species (MUMS) designation granted by the FDA impact AB Science Paris Ord ABSCF's strategy for the commercialization of Masivet in the USA compared to its current status in Europe?
Can AB Science Paris Ord ABSCF elaborate on the specific incentives the company expects from the MUMS status to support the approval process for Masivet in the USA?
What are AB Science Paris Ord ABSCF's plans for distribution and commercialization agreements in the targeted regions, and how do they align with the expected demand for Masivet?
How does the expected EBITDA contribution from animal health, including Masivet, impact AB Science Paris Ord ABSCF's overall financial stability and risk management strategy moving forward?
**MWN-AI FAQ is based on asking OpenAI questions about Ab Science Paris Ord (OTC: ABSCF).
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