Welcome to our dedicated page for Alvotech news (Ticker: ALVO), a resource for investors and traders seeking the latest updates and insights on Alvotech stock.
Alvotech (NASDAQ: ALVO) is a biotechnology company dedicated exclusively to biosimilars, and its news flow reflects the progress of a global biosimilar platform. Company updates frequently cover regulatory milestones, such as marketing authorizations in the European Economic Area, the United Kingdom and Japan for products referencing Prolia and Xgeva (denosumab), Simponi (golimumab) and Eylea (aflibercept). Press releases also highlight clinical and regulatory developments for new candidates, including submissions to agencies like the European Medicines Agency and the U.S. Food and Drug Administration.
Investors following ALVO news can expect regular announcements on product approvals, pipeline progress and legal or regulatory outcomes. Recent communications have described European Commission approval of AVT03, a biosimilar to Prolia and Xgeva, positive opinions from EMA committees for AVT03 and AVT05, and a settlement and license agreement enabling a future U.S. launch of AVT06, a proposed biosimilar to Eylea, subject to FDA approval. Other items include court decisions related to manufacturing activities for AVT06 and updates on applications for additional candidates such as AVT23.
Alvotech’s news flow also includes capital markets and financing transactions, such as senior unsecured convertible bond offerings and a senior term loan facility, which the company states are intended to support its research and development pipeline, manufacturing capacity and global product launches. Earnings-related press releases and business updates provide guidance ranges for revenues and adjusted EBITDA, along with commentary on order books, launch timing and investment programs.
Corporate governance and leadership changes are another recurring theme. For example, Alvotech has announced a planned CEO succession in which the founder will remain as Executive Chairman while a new Chief Executive Officer takes over day-to-day leadership. For users tracking ALVO, this news page offers a centralized view of regulatory, financial and strategic developments affecting the company’s biosimilar portfolio and global partnerships.
Alvotech (NASDAQ: ALVO) has launched Hukyndra®, a biosimilar to Humira® (adalimumab), in Switzerland as part of an exclusive partnership with STADA. This new high-concentration, low-volume, citrate-free formulation aims to improve access to biologics for patients in Europe. Hukyndra is available in two presentations and already has approvals in multiple European countries, including the UK and Switzerland. The partnership encompasses six biosimilar candidates, with STADA tasked with commercialization and Alvotech managing development and manufacturing.
Alvotech (NASDAQ: ALVO) announced on September 5, 2022, that it received a Complete Response Letter from the FDA regarding its biosimilar Biologics License Application (BLA) for AVT02, following an inspection of its Reykjavik facility. The FDA cited deficiencies that must be resolved before approval can be granted. CEO Mark Levick expressed commitment to addressing these issues before the Biosimilar User Fee Act goal date in December and anticipates a launch readiness by July 1, 2023. AVT02, a biosimilar to Humira, has been approved in several countries, and its U.S. approval remains pending.
Alvotech (NASDAQ: ALVO) announced the FDA's Complete Response Letter regarding its biosimilar BLA for AVT02, indicating deficiencies found during a March 2022 inspection of its Reykjavik facility. Approval will be contingent upon resolving these issues. CEO Mark Levick expressed optimism about addressing the deficiencies ahead of the December goal date for the BLA. AVT02, comparable to Humira, is already approved in several countries and is anticipated to launch in the U.S. by July 1, 2023.
Alvotech (NASDAQ: ALVO) announced a successful merger with OACB, securing approximately $185 million in gross proceeds. The company reported $40.1 million in revenue for the first half of 2022, a significant rise from $2.0 million during the same period in 2021. Alvotech launched AVT02 (adalimumab) in Canada and Europe, and reported positive results from its clinical pipeline, including biosimilars to Stelara and Xolair. The company plans to transition its Icelandic listing to the Nasdaq Main Market and will hold a business update call on September 1, 2022.
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Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT03, a biosimilar candidate to Prolia® and Xgeva®. The study aims to establish clinical similarity in efficacy and safety for treating osteoporosis in postmenopausal women. Prolia® and Xgeva® had combined sales of nearly $5.3 billion in 2021. The multicenter study will involve around 476 women, with results expected after 12 to 18 months. Alvotech, focused on biosimilars, seeks to enhance access to affordable biologic treatments globally.
Alvotech (NASDAQ: ALVO), a global biotech firm focusing on biosimilars, announced participation in two investor conferences in September 2022. The leadership team will engage in fireside chats at Citi’s 17th Annual Biopharma Conference on September 8 at 2:40 pm ET and at Morgan Stanley’s 20th Annual Global Healthcare Conference on September 12 at 2:15 pm ET. A replay of these discussions will be available on their website for 90 days. Alvotech aims to lead in the biosimilar sector with a pipeline of eight candidates addressing various medical conditions.
Alvotech (NASDAQ: ALVO), a global biotech company, has announced participation in two investor conferences in September 2022. The leadership team will engage in fireside chats at:
- Citi’s 17th Annual Biopharma Conference on September 8 at 2:40 pm ET
- Morgan Stanley’s 20th Annual Global Healthcare Conference on September 12 at 2:15 pm ET
Webcast replays will be accessible on the Investors Section of Alvotech’s website for 90 days.
Alvotech (NASDAQ: ALVO) announced it will release its financial results for Q2 and the first half of 2022 on August 31, 2022, after U.S. market close. Following the release, a business update conference call and webcast will take place on September 1, 2022, at 8:00 am ET. Alvotech specializes in biosimilar medicines, with a pipeline of eight candidates targeting various diseases. The company emphasizes growth through strategic global partnerships across multiple regions, including the U.S., Europe, and Asia.
Alvotech (NASDAQ: ALVO) is set to transition its share listing from the First North Growth Market to the Nasdaq Main Market in Iceland. This move aims to enhance visibility and potential inclusion in both Icelandic and international indexes, particularly the FTSE Global All Cap. The decision comes after Alvotech became the first Icelandic company dual-listed in the U.S. and Iceland in June 2022. The company specializes in biosimilar medicines, with a product portfolio targeting an estimated total addressable market exceeding US$85 billion.