Core Viewpoint - AB Science has received FDA's Minor Use in Major Species (MUMS) designation for Masivet® to treat canine mast cell tumors, which is expected to facilitate its development and commercialization in the USA [1][3][4]. Company Overview - AB Science is a pharmaceutical company founded in 2001, specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs) targeting diseases with high unmet medical needs [7][8]. - The company is headquartered in Paris, France, and is listed on Euronext Paris [8]. Product Information - Masivet® is a targeted therapy that inhibits juxtamembrane mutations of c-kit, the main driver of dog mast cell tumors [2]. - The MUMS designation provides seven years of exclusive marketing rights upon approval and eligibility for grants to support the approval process [3]. Market Potential - Masivet® is already registered and profitable in Europe but not yet in the USA; the MUMS status is seen as a significant encouragement for its development in the US market [4]. - AB Science aims to expand its animal health franchise, with expectations that EBITDA from this segment will help cover fixed costs and contribute to the company's financial stability [4]. Global Expansion Plans - The company is in discussions for distribution and commercialization agreements in various regions, including Europe (Norway, Denmark, Sweden, Finland, Lithuania), LATAM (Brazil, Argentina, Mexico), Asia (Japan, Taiwan), MENA regions, and South Africa [5]. - There is a global demand for Masivet, with positive feedback from pet owners and veterinarians regarding its safety and effectiveness [6].
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