Alvotech (ALVO) stock jumped around 8% on Wednesday after Barclays analyst Glen Santangelo flipped his rating on the shares from Underweight to Overweight and doubled his price target from $4 to $8.

The move was one of the sharper single-day gains the stock has recorded, marking its largest rise since last December, according to Dow Jones Market Data. Shares were trading around $5.42 on Wednesday, still well below their 52-week high of $9.25.

Alvotech, headquartered in Reykjavik, Iceland, specializes in biosimilars — biologic medicines designed to be highly similar to approved reference products, with no clinically differences in safety, purity, or potency. For drugmakers, biosimilars offer a route into large, established markets for originator biologics, typically competing at lower prices once regulatory exclusivity on the reference product runs out.

The upgrade followed a key regulatory development. In July, the U.S. Food and Drug Administration formally closed its inspection of Alvotech's manufacturing facility in Reykjavik, issuing a "Voluntary Action Indicated" classification — the FDA's most favorable inspection outcome.

The Iceland plant had previously been a source of concern for investors. During earlier inspections, the FDA flagged deficiencies in manufacturing standards and facility compliance, which had held up product approvals. The drug candidates themselves showed no deficiencies; the issues were confined to the facility. The classification resolved the principal regulatory obstacle that had stalled the company's U.S. product reviews. Under the FDA's framework for biologics, a license covers both the product and the specific site where it is made, which is why inspection outcomes carry such a direct bearing on approval timelines.

With the facility matter resolved, Alvotech resubmitted biologics license applications in June for three biosimilar products. The FDA's decision deadline for all three is December 4, 2026.

Three Biosimilars in the Pipeline

The three candidates awaiting approval are biosimilars targeting chronic inflammatory conditions, ophthalmology, and bone health. AVT05 is a biosimilar to Simponi, the Johnson & Johnson drug used to reduce joint pain. AVT06 is Alvotech's version of Eylea, a treatment co-developed by Regeneron and Bayer to treat retinal disorders and prevent vision loss. AVT03 replicates Prolia and Xgeva, two Amgen bone-protection medications.

The FDA has also accepted a biologics license application for AVT16, a biosimilar to Takeda's Entyvio, a therapy used in inflammatory bowel conditions, with a decision expected in early 2027.

Santangelo noted that full-scale manufacturing resumed in the second quarter of 2026. Management has reaffirmed its revenue guidance of $650 million to $700 million for fiscal 2026.

Expansion Beyond Iceland

Alvotech has also been working to add manufacturing capacity outside of Iceland. The company has a partnership with Fujifilm Biotechnologies in the United States, with expanded capacity expected to come online in 2027. The arrangement gives Alvotech a second production base beyond its Reykjavik plant, positioned closer to the U.S. market where its pending applications would compete.

Santangelo said the stock is an attractive buy for investors, citing the regulatory progress and the clear timeline for potential approvals before year-end.

The broader market was positive on Wednesday, with the S&P 500 up 0.2% and the Nasdaq gaining 0.4%, though Alvotech's move far outpaced the broader indexes.

The stock is currently trading well below its 52-week high of $9.25, with three FDA decisions due by December 4, 2026 — the same timeline Santangelo pointed to in making his case.