Hyrnuo: how long were the pivotal tox studies?

“The toxicity, the reversibility of effects, and exposures of sevabertinib were assessed in repeat dose, toxicology studies, up to 13 weeks duration in rats and monkeys.”

“Daily oral administration of sevabertinib to rats and monkeys over 2, 4, or 13 weeks revealed adverse effects characterized by general signs of toxicity, such as reduced food intake, changes in laboratory parameters, diarrhea, and degenerative and inflammatory processes in epithelial and mucosal tissues.”

“The oral route of administration is consistent with the intended clinical route of administration.”