Alvotech (ALVO) announced Monday positive results from a pharmacokinetic study for AVT03, a biosimilar candidate to Prolia and Xgeva, which both contain denosumab.
In the pre-market session, the shares gained more than 10 percent to $14.65.
The Iceland-based specialty and generic drug manufacturer said its PK study - AVT03-GL-P01 met its primary endpoints while assessing the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects. A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.
Prolia is indicated for the treatment of osteoporosis in postmenopausal women and bone loss in adult men and women at increased risk of fracture. Xgeva is also denosumab but in a different presentation, is indicated for the prevention of skeletal-related events such as pathological fractures in adults with advanced malignancies involving bone.
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