Alvotech ALVO.SDB

Stockholm | Biotech | Biosimilar medicines

General analysis — not personal advice.

Signal

NEUTRAL

Sentiment

6/10

Risk

7/10

The BLA resubmissions are a material catalyst that reduces timeline uncertainty versus the post-CRL/inspection period, but overall risk remains elevated because FDA outcomes and quality/manufacturing execution are still binary drivers.

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Price & valuation

Last close

SEK 37.25

2026-08-11

1 week

+0.8 %

3 months

+15.3 %

12 months

-55.8 %

From 52w high

-56.4 %

From 52w low

+33.8 %

Market sentiment

Sentiment has improved following the BLA resubmissions and the message that inspection observations are manageable, but is tempered by weaker Q1 revenue and ongoing regulatory/manufacturing execution risk.

Why NEUTRAL?

Reassess positioning: keep a core exposure if you can tolerate regulatory risk, but avoid aggressive adds until a clearer FDA timeline/acceptance (e.g., communicated PDUFA dates) emerges.

We're already tracking Alvotech — here are the latest events we've registered

Recent News

On June 4, 2026 Alvotech (with Teva) resubmitted revised BLAs to the FDA for AVT05 (Simponi/Simponi Aria biosimilar, golimumab) and AVT06 (Eylea biosimilar, aflibercept). On May 11 the company said the FDA completed a routine cGMP surveillance inspection of the Reykjavik facility (Form 483 issued) and management believes the observations are addressable. The stock reacted positively to the resubmission, though the company remains pressured by the Q1 miss versus consensus.

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