FDA Accepts Alvotech's BLA for Subcutaneous Entyvio Biosimilar AVT80
ALVO sits 69% above its 52-week low of $2.94.
Summary
The FDA accepted Alvotech's BLA for AVT80, a proposed interchangeable biosimilar to Entyvio for subcutaneous administration via prefilled syringe and autoinjector. This expands the vedolizumab program beyond the intravenous AVT16, whose BLA was accepted in May. Under the Teva partnership, Alvotech handles development and manufacturing while Teva commercializes. Acceptance triggers a formal review, a key step toward potential U.S. approval and pharmacy-level substitution. The company's H1 2026 results showed a net loss and revenue decline, but this regulatory progress supports the pipeline narrative. Watch for FDA action dates and any Complete Response Letter, which would be a material setback.
At the time of this announcement, ALVO was trading at $4.98 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.9B. The 52-week trading range was $2.94 to $9.25. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.