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 S.A. has submitted an application to Nasdaq Iceland for its shares to be traded on the Nasdaq Iceland Main Market under the ticker symbol “ALVO.” This application is currently pending approval. Alvotech's shares are already trading on the Nasdaq Stock Market in the U.S. and the Nasdaq First North Growth Market. The company's Board of Directors announced the plan to move its listing to the Nasdaq Main Market in Iceland on August 12, 2022.
Alvotech (NASDAQ: ALVO) has successfully secured approximately $136 million in financing to advance its biosimilar pipeline, as announced on November 16, 2022. This includes a $70 million upsize of existing senior bonds and a $50 million unsecured loan from Alvogen, a major shareholder. Additionally, Alvotech is acquiring its Reykjavik manufacturing facility for $80 million using an unsecured convertible bond and will refinance secured loans for around $16 million. These moves aim to enhance operational flexibility and support the development of eight biosimilar candidates.
Alvotech (NASDAQ: ALVO) reported a remarkable revenue increase for the first nine months of 2022, reaching $59.2 million compared to $2.0 million in 2021. The company is progressing talks with the U.S. FDA regarding its biologic license applications for AVT02, targeting a U.S. launch on July 1, 2023. Furthermore, Alvotech has submitted marketing applications for AVT04 in major markets and expanded its partnership with JAMP Pharma. Total cash and equivalents stood at $12.8 million, despite significant debts of $518.6 million, while the net loss narrowed to $193.1 million.
Alvotech (NASDAQ: ALVO) announces that its biosimilar AVT02, a high-concentration, low-volume formulation of adalimumab, has received marketing authorization from the Therapeutic Goods Administration in Australia. Marketed under the names Ciptunec™ and Ardalicip™, this biosimilar is now available for various indications, including rheumatoid arthritis and Crohn's disease. This is the first biosimilar resulting from Alvotech's partnership with Cipla, aiming to enhance access to affordable biologics in Australia and other regions.
Alvotech (NASDAQ: ALVO) announced its participation in the American College of Rheumatology (ACR) Convergence Conference, where it will present two posters and host an Ignite Talk on its switching study for ATV02.
The study focuses on the pharmacokinetics, immunogenicity, efficacy, and safety of switching between Humira and AVT02, a high-concentration biosimilar candidate. The FDA accepted Alvotech’s Biologics License Application for interchangeability in February 2022, currently under review. This work emphasizes improving patient access to biologics while reducing costs.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilars, is set to release its financial results for the first nine months of 2022 on November 15, 2022, after U.S. market close. A business update conference call will follow on November 16, 2022, at 8:00 am ET. Alvotech aims to be a leader in biosimilar medicines, with eight candidates in its pipeline targeting diseases such as autoimmune disorders and cancer. The company is partnered with numerous commercial entities globally to enhance market reach.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilar medicines, will participate in the Jefferies London Healthcare Conference from November 15 to November 17, 2022. The leadership team plans to present on November 17 at 10:25 am GMT and will conduct investor meetings throughout the event.
A webcast of the presentation will be accessible on Alvotech’s website for 90 days post-conference.
Alvotech (NASDAQ: ALVO) has announced an expanded partnership with JAMP Pharma Group to commercialize two new biosimilar candidates, AVT16 and AVT33, in Canada. This partnership builds on their previous success with Simlandi™, a biosimilar to Humira, launched in April 2022. Alvotech will develop and supply these biosimilars, while JAMP Pharma will manage marketing and sales in Canada, aiming to enhance patient access to affordable biologics. The partnership aligns with Alvotech's goal to lead in the Canadian biosimilars market.
Alvotech (NASDAQ: ALVO), a biotech firm, has announced that its partner, Fuji Pharma Co., Ltd., has submitted a marketing approval application to Japan's Ministry of Health for their first biosimilar candidate. This marks a significant milestone in their exclusive partnership aimed at increasing access to essential biologics in Japan. Alvotech's pipeline includes eight biosimilar candidates targeting various diseases, positioning them to meet the rising demand for biosimilars in Japan and beyond.
Alvotech (NASDAQ: ALVO) announced the appointment of Sarah Tanksley as its new Chief Quality Officer, effective October 14. She succeeds Reem Malki, who stepped down for personal reasons. Tanksley, having previously consulted for Alvotech, brings over 20 years of experience from regulatory agencies like the FDA and the NIH. Her expertise in regulatory compliance and GMP is expected to facilitate a smooth transition and enhance Alvotech's capabilities.
Alvotech focuses on developing biosimilar medicines to serve patients globally.