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), the first Icelandic company dual-listed in the U.S. and Iceland, is set to move its shares to the Nasdaq Main Market in Iceland. This transition, approved by its Board of Directors, aims to enhance visibility and may lead to inclusion in international indexes like FTSE Global All Cap. Alvotech's current portfolio targets over US$85 billion market potential across several therapeutic areas, including autoimmune disorders and cancer. The move is subject to a rigorous application process and aligns with the company's ambition to strengthen its market presence.
Alvogen announced a significant district court ruling in favor of its proposed generic version of Xifaxan®, a treatment for irritable bowel syndrome with diarrhea (IBS-D). This ruling advances Alvogen's goal of providing a more affordable alternative for patients. Robert Wessman, Chairman of Alvogen, expressed satisfaction with the decision, noting its importance in delivering accessible treatment options. Alvogen specializes in developing, manufacturing, and selling both generic and branded pharmaceutical products, and is committed to expanding its market presence.
Alvotech (NASDAQ: ALVO) announced the initiation of a pharmacokinetic study for AVT03 (denosumab), a biosimilar candidate to Prolia® and Xgeva®, aimed at evaluating its safety and tolerability in healthy adult males. The combined sales of Prolia® and Xgeva® approached $5.3 billion in 2021. This milestone expands Alvotech’s clinical portfolio, which now includes four products under development. The company emphasizes its mission to enhance access to affordable biologic medicines, as stated by Chief Scientific Officer Joseph McClellan.
Alvotech (NASDAQ: ALVO) has expanded its Board of Directors to include four new members, enhancing its independence and diversity. The new board members are Lisa Graver, Arni Hardarson, Linda McGoldrick, and Ann Merchant, who join existing members including Executive Chairman Robert Wessman. This strategic move aims to strengthen governance as the company transitions from private to public. The expertise of the new members in scientific, operational, and capital markets will support Alvotech's mission to improve access to biologic medicines globally.
Alvotech (NASDAQ: ALVO) announced the initiation of its confirmatory clinical study for AVT06, a biosimilar candidate to Eylea® (aflibercept). This third biosimilar candidate will compare AVT06 with Eylea® regarding efficacy, safety, and immunogenicity in approximately 444 participants with neovascular age-related macular degeneration. Eylea® generated nearly US$10 billion in sales in 2021. Alvotech is focused on developing biosimilars to improve patient lives globally, with promising advancements in its product pipeline, including approved biosimilars targeting autoimmune diseases and other health conditions.
Alvotech (NASDAQ: ALVO) has initiated a confirmatory clinical study for its biosimilar candidate, AVT06, which targets Eylea® (aflibercept). This study aims to enroll approximately 444 participants globally and will assess efficacy, safety, and immunogenicity in adult patients with neovascular age-related macular degeneration (AMD). The primary endpoint is the change in best corrected visual acuity from baseline to week 8.
Eylea® generated nearly US$10 billion in sales in 2021, highlighting the market potential for AVT06.
The board of Alvotech has approved a share capital increase of $270,721.67 by issuing 27,072,167 new ordinary shares, raising the total from 243,649,505 to 270,721,672 shares. The newly issued shares were subscribed by Alvotech Manco ehf. at $10 each. This capital raise aims to meet obligations from warrants linked to the business combination with Oaktree Acquisition Corp. II and to support the management incentive plan. The new shares will be treated as treasury shares, without voting rights or dividend entitlement.
Alvotech is set to list its shares under the ticker symbol ALVO on the Nasdaq First North Growth Market in Iceland starting June 23, following its debut on the Nasdaq Stock Market on June 16. This dual listing will give Icelandic investors access to a global company specializing in biosimilars. Alvotech has invested over 1 billion dollars in developing a scalable biosimilar platform and offers eight products targeting various conditions, representing a total addressable market exceeding US$85 billion. The company also anticipates replacing redemptions with new financing facilities.
Alvotech has published a supplement to its Company Description in connection with the Form 20-F filing with the U.S. SEC. This supplement, dated June 22, 2022, must be read alongside the Company Description dated June 21, 2022. It is available on Alvotech's website for stakeholders to review.
Alvotech has announced its pending listing of common shares on the Nasdaq First North Growth Market in Iceland under the symbol ALVO. The expected trading start date is June 23, 2022. The company has issued a total of 243,649,505 shares, each with a nominal value of USD 0.01. Alvotech was previously listed on the Nasdaq Stock Market on June 16, 2022. The company focuses on developing biosimilars, with a pipeline addressing an estimated market of over $85 billion for various therapeutic areas. The complete Company Description is available on Alvotech's website.