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Alvotech holds rating despite H1 2026 earnings miss and FDA delays, eyes multiple biosimilar approvals by Q4 2026.

Market News
20 Aug 2026
Seeking Alpha
View Source
Neutral
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Alvotech maintains a Hold rating after missing H1 2026 earnings expectations and facing regulatory challenges, including FDA Complete Response Letters (CRLs) for its biosimilars AVT05 and AVT06 due to manufacturing issues now resolved. The company has resubmitted Biologics License Applications (BLAs) and aims for multiple approvals by Q4 2026. AVT06, a biosimilar to EYLEA, has secured global commercialization rights post-November 2026, with patent disputes settled, presenting a significant market opportunity. However, Alvotech's cash runway is limited to 12 months, and further financing may be needed, potentially causing dilution as it supports commercialization efforts.

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