Dawnzera: how long were the pivotal tox studies?

“repeat dose studies in CD-1 mice and cynomolgus monkeys of up to 26- and 39-week duration, respectively”

“plasma TK profile of SC administration of donidalorsen was evaluated in a GLP-compliant 13-week interim/39-week repeat-dose toxicity study in Cynomolgus monkeys with a 26-week treatment-free recovery period”

“The subcutaneous (SC) route of administration was used, as this is the intended therapeutic route in humans.”