AZTR receives NYSE delisting warning over equity requirement
REYKJAVIK - Alvotech (NASDAQ:ALVO), a $2.47 billion market cap biotech company trading near its 52-week low of $7.35, announced Monday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for AVT03, its proposed biosimilar to Prolia and Xgeva (denosumab). According to InvestingPro data, the company has maintained a robust gross profit margin of 54% over the last twelve months.
The positive opinion covers both the 60 mg/mL single-use pre-filled syringe and 70 mg/mL single-use vial formulations of denosumab. Pending final European Commission approval, the biosimilar will be marketed in Europe by Alvotech’s commercial partners STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA.
Denosumab is used to treat osteoporosis in postmenopausal women and men at increased risk of fracture, bone loss in men receiving prostate cancer treatment, and bone loss in adults treated long-term with corticosteroids. The 70 mg/mL formulation is used to prevent bone complications in patients with advanced cancer that has spread to bone and to treat giant cell tumor of bone.
"We look forward to working with our partners in making denosumab available more widely to patients and caregivers," said Joseph McClellan, Chief Scientific and Technical Officer of Alvotech, according to the company’s press release.
Upon approval, STADA will market the biosimilar under the tradenames Kefdensis (60 mg/mL) and Zvogra (70 mg/mL), while Dr. Reddy’s will use the tradenames Acvybra and Xbonzy for the respective formulations.
Alvotech specializes in the development and manufacture of biosimilar medicines. The company has already received approval for biosimilars to Humira (adalimumab) and Stelara (ustekinumab) in multiple global markets.
In other recent news, Alvotech reported strong financial results for the second quarter of 2025. The company posted an earnings per share of $0.50, significantly surpassing the forecast of -$0.0023. This resulted in an extraordinary earnings surprise of 21,839.13%. Revenue also exceeded expectations, reaching $204.7 million compared to the anticipated $120.51 million, marking a 69.86% revenue surprise. Additionally, Alvotech announced that its Japanese partner, Fuji Pharma, has obtained marketing approval for three biosimilar medicines from Japan’s Ministry of Health, Labor and Welfare. These include AVT03, AVT05, and AVT06, with AVT05 being the first golimumab biosimilar approved for sale in major markets globally. Despite the impressive earnings figures, the market’s immediate reaction was negative. However, the approval of these biosimilars in Japan represents a significant development for Alvotech.
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