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Alvotech Ordinary Shares - ALVO STOCK NEWS

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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines aimed at enhancing patient access to affordable treatments worldwide. Established in 2013, the company has committed itself to becoming a leader in biogenerics, focusing on the creation of cost-effective biosimilars that meet stringent quality standards. Alvotech operates through a fully integrated model, addressing every step from cell line development to commercial manufacturing.

Alvotech's headquarters in Reykjavik, Iceland hosts a state-of-the-art flexible manufacturing facility that underscores the company's commitment to high-quality and efficient production. The company's portfolio includes biosimilars for autoimmune disorders, eye conditions, osteoporosis, respiratory diseases, and cancer. Alvotech has successfully launched two biosimilars and is actively working on nine more candidates.

In recent developments, Alvotech announced positive top-line results for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and has received FDA approval for AVT04, a biosimilar to Stelara®. The company is also advancing in its U.S. strategic partnership with Teva Pharmaceuticals for the high-concentration interchangeable biosimilar to Humira®, marketed under Quallent’s private label. Financially, Alvotech reported increased revenues of $37 million in Q1 2024 and strengthened its position with a strategic refinancing transaction led by GoldenTree Asset Management, enhancing its financial flexibility and reducing upcoming debt maturities.

Alvotech's global reach is bolstered by strategic commercial partnerships with renowned pharmaceutical companies like Teva, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and many others. These collaborations extend across the United States, Europe, Japan, China, and several other regions, leveraging local expertise to provide expansive market access.

For more information on Alvotech and to stay updated with the latest news, visit www.alvotech.com.

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STADA and Alvotech receive marketing authorization for Uzpruvo, a biosimilar to Stelara, in the European Economic Area, paving the way for biosimilar competition in the €2.5 billion EU ustekinumab market after the expiry of intellectual-property rights in July 2024. The European Commission's decision offers the potential to expand patient access through competition, with Uzpruvo being based on comprehensive package comprising analytical, non-clinical, and clinical similarity data, including a confirmatory comparative efficacy and safety clinical trial in patients with moderate to severe chronic plaque-type psoriasis.
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Alvotech (NASDAQ: ALVO) announced positive top-line results from a confirmatory clinical study for AVT06, their proposed biosimilar to Eylea® (aflibercept), meeting its primary endpoint in patients with neovascular (wet) Age-related Macular Degeneration (AMD). This development showcases the advantage of their integrated development and manufacturing platform, allowing the company to pursue a diversified global biosimilar strategy. Eylea is a widely used biologic for the treatment of eye disorders, with cumulative global sales in the last twelve months before September 30, 2023.
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Alvotech (NASDAQ: ALVO) announced positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® (golimumab), meeting its primary endpoints. The study assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult subjects. Alvotech's current portfolio includes one launched product, one approved biosimilar, and four biosimilar candidates in clinical studies, including AVT05.
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Alvotech (NASDAQ: ALVO) will release financial results for the first nine months of 2023 after the U.S. markets close on Tuesday, November 28, 2023. A business update conference call for analysts will be held on Wednesday, November 29, 2023, at 8:00 am ET (1 pm GMT). Live audio of the conference call will be webcast and available to the public. Information on how to access the webcast or participate by conference call is posted on Alvotech’s investor website.
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Alvotech (ALVO) announced positive top-line results from a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). The study met its primary endpoints, demonstrating the strength of Alvotech's platform approach to biosimilars development and manufacture. The company also announced the initiation of a clinical study to compare the efficacy, safety, and immunogenicity of AVT05 and Simponi® in adult patients with moderate to severe rheumatoid arthritis. Alvotech's current portfolio includes one launched product, one approved biosimilar, and four biosimilar candidates in clinical studies, including AVT05.
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Alvotech (NASDAQ: ALVO) reported a significant increase in product revenue for the first nine months of 2023, reaching $29.8 million compared to $11.1 million for the same period in 2022. The company also received marketing authorization for AVT04 in Canada and Japan, and a positive CHMP opinion in the European Economic Area. However, the financial results show a net loss of $275.2 million for the period, with a decrease in license and other revenue and an increase in R&D and G&A expenses.
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Alvotech (NASDAQ: ALVO) reported a significant increase in product revenue to $29.8 million for the first nine months of 2023 compared to $11.1 million for the same period in 2022. The company received marketing authorization for AVT04 in Canada and Japan and proposed market authorization in the European Economic Area. However, the company also reported a net loss of $275.2 million for the period, which is a negative aspect.
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Alvotech (ALVO) will release financial results for the first nine months of 2023 after U.S. markets close on November 28, 2023. The company will conduct a business update conference call for analysts on November 29, 2023, at 8:00 am ET.
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STADA and Alvotech receive a positive CHMP opinion for Uzpruvo, the first biosimilar to Stelara in the European Economic Area. This biosimilar is designed to treat conditions in gastroenterology, dermatology, and rheumatology. The approval is based on comprehensive data, including pharmacokinetic and clinical trials, with the potential to significantly expand patient access to this €2.5 billion market.
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Alvotech (NASDAQ: ALVO) and JAMP Pharma Group announced that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® developed by Alvotech. The biosimilar will be marketed under the brand name JamtekiTM, making it the second biosimilar developed under their exclusive partnership to receive marketing authorization in Canada. This announcement reflects the growing demand for affordable quality biologics in the Canadian market and highlights the commitment of both companies to offer broader access to more affordable healthcare. The introduction of JamtekiTM aligns with JAMP Pharma's goal to establish itself as a leader in the Canadian biosimilars market, and it is supported by the expertise of their Patient Support Program - JAMP CareTM - designed to simplify the transition process to biosimilar medicines for patients and caregivers.
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FAQ

What is the current stock price of Alvotech Ordinary Shares (ALVO)?

The current stock price of Alvotech Ordinary Shares (ALVO) is $11.91 as of December 20, 2024.

What is the market cap of Alvotech Ordinary Shares (ALVO)?

The market cap of Alvotech Ordinary Shares (ALVO) is approximately 3.7B.

What does Alvotech specialize in?

Alvotech specializes in the development and manufacturing of high-quality biosimilar medicines aimed at making treatments more affordable and accessible globally.

Where is Alvotech headquartered?

Alvotech is headquartered in Reykjavik, Iceland.

What are some recent achievements of Alvotech?

Recently, Alvotech announced positive top-line results for its AVT05 biosimilar and received FDA approval for AVT04, a biosimilar to Stelara. The company also secured a strategic refinancing transaction led by GoldenTree Asset Management.

Who are Alvotech's key commercial partners?

Alvotech's key commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and Cipla among others, extending its market reach across the U.S., Europe, Japan, China, and more.

How does Alvotech ensure high-quality production?

Alvotech ensures high-quality production through its state-of-the-art flexible manufacturing facility located in Reykjavik, Iceland, and a fully integrated model addressing every step from cell line development to commercial manufacturing.

What is the financial outlook for Alvotech in 2024?

Alvotech has raised its revenue guidance for 2024 to $400-$500 million and tightened its guidance for EBITDA to $100-$150 million, driven by rapid progress in commercialization and development.

What are biosimilars?

Biosimilars are biologic medical products highly similar to already approved reference products, offering comparable quality, safety, and efficacy at a lower cost.

What diseases do Alvotech's biosimilars target?

Alvotech's biosimilars target autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and various cancers.

How does Alvotech contribute to global healthcare?

Alvotech contributes to global healthcare by developing cost-effective biosimilar medicines, increasing access to life-altering therapies, and forming strategic partnerships to maximize global reach.

Where can I find more information about Alvotech's investor relations?

More information about Alvotech's investor relations can be found on their investor portal at https://investors.alvotech.com.

Alvotech Ordinary Shares

Nasdaq:ALVO

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3.65B
104.58M
64.01%
6.04%
0.03%
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