Alvotech shares surge 13.95% premarket after positive PK study results for Entyvio biosimilar support regulatory submissions.

Alvotech surged 13.95% in premarket trading following the announcement of positive top-line results from a pivotal pharmacokinetic study for AVT80, a proposed biosimilar to Entyvio. The randomized, double-blind trial met all primary endpoints for PK similarity and demonstrated safety and tolerability in healthy adults, advancing regulatory submissions for both subcutaneous AVT80 and intravenous AVT16. The study’s success underscores progress in Alvotech’s biosimilar pipeline, targeting a drug (Entyvio) with $6.4 billion in 2025 global sales. Other news, including a prior FDA rejection and a bullish thesis on growth, were either older or less immediately impactful, while Fuji Pharma’s profit forecast cut related to Alvotech shares did not directly drive the premarket rally.