Alvotech Reports Strong FY25 Revenue Growth, Targets Q2 2026 FDA Resubmission
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Alvotech announced robust Q4 and full-year 2025 financial results, with total revenues for FY25 increasing 21% year-over-year to $593 million and Adjusted EBITDA rising 27% to $137 million. The company also reported significant pipeline progress, including multiple biosimilar approvals in the UK and EEA, an EMA acceptance for review of AVT23, and the launch of its second US biosimilar, Selarsdi™. Critically, Alvotech provided an update on its FDA inspection observations, stating an expectation to resubmit affected applications during the second quarter of 2026. This comprehensive update, combining strong financial performance with a clear timeline for addressing a key regulatory hurdle, provides important clarity for investors. Traders will closely monitor the anticipated FDA resubmission and subsequent regulatory decisions, as successful US market entry for its biosimilar candidates is a major catalyst.
At the time of this announcement, ALVO was trading at $3.78 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.3B. The 52-week trading range was $3.45 to $11.85. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.