Alvotech Stock Price, News & Analysis

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has received a complete response letter (CRL) from the U.S. FDA regarding its partner Alvotech's (NASDAQ: ALVO) Biologics License Application for AVT02, a biosimilar to Humira (adalimumab). The FDA's CRL indicates that the application cannot be approved due to deficiencies identified at Alvotech's manufacturing facility, which need resolution. Despite this setback, Teva reaffirms its commitment to leadership in the biosimilars market and expresses optimism about its product pipeline, including further advancements with AVT02.

Alvotech (NASDAQ: ALVO) announced that the FDA issued a complete response letter (CRL) for its Biologics License Application (BLA) for AVT02, a biosimilar candidate for Humira. The CRL highlighted deficiencies that must be resolved following a recent FDA reinspection of Alvotech’s Reykjavik facility. No other application deficiencies were indicated. Alvotech submitted a comprehensive response to the FDA on April 3, 2023, and is awaiting further communication. Additionally, a second BLA for AVT02, aiming for potential interchangeability designation, is under review with a goal date of June 28, 2023. The company is focused on addressing the noted issues to ensure approval and aims to provide a high-concentration formulation of Humira for U.S. patients.

Alvotech, a biotech company focused on biosimilars, announced the presentation of two posters at the 2023 American Academy of Dermatology Annual Meeting concerning its candidate AVT04 (ustekinumab), a proposed biosimilar to Stelara®. These posters detail pharmacokinetic and confirmatory clinical studies that support AVT04's biosimilarity and comparative outcomes. The Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency and a Biologics License Application (BLA) to the FDA earlier this year. The studies were conducted with healthy volunteers and patients, showing promising results.

Alvotech reported a 114% increase in total revenue for the full year 2022, reaching $85.0 million compared to $39.7 million in 2021. The growth was driven by milestone and product revenue from the commercialization of AVT02, a biosimilar to Humira®, across 17 countries. The company advanced three biosimilar candidates into clinical development and submitted marketing applications for AVT04, a proposed biosimilar to Stelara®. Despite the revenue growth, Alvotech reported a net loss of $513.6 million. The FDA has set an action date of April 13, 2023, for AVT02's licensing application, and a reinspection of the Reykjavik manufacturing site is scheduled for March 6, 2023.

Alvotech (NASDAQ: ALVO) will announce its full-year 2022 financial results after U.S. markets close on March 1, 2023. Following this, a business update conference call is scheduled for March 2, 2023, at 8:00 am ET. Investors and media can access the live webcast and subsequent replay for 90 days on Alvotech's investor website. Alvotech specializes in biosimilars aimed at treating various diseases, including autoimmune disorders, cancer, and respiratory diseases. The company aims to lead the biosimilar market with a pipeline of eight candidates and strategic partnerships across global markets.

Alvotech (Nasdaq: ALVO) has updated its market making agreement with Landsbankinn hf., effective February 15, 2023. This agreement, which has been in place since Alvotech's shares began trading in Iceland on June 23, 2022, ensures that Landsbankinn will make bids and offers for ALVO shares on Nasdaq Iceland.

The new terms raise the bidding and offering amounts from ISK 5 million to ISK 10 million, and the daily trading cap increases from ISK 10 million to ISK 20 million. The spread between bid and ask prices remains tied to the shares' trailing volatility.

Alvotech (NASDAQ: ALVO) announced the successful completion of a Private Share Placement, where 11,834,061 treasury shares were transferred to counterparties. The net cash proceeds will be used for general corporate purposes and to reduce reliance on the Standby Equity Purchase Agreement with YA II PN, Ltd. This transaction is directed solely into Iceland to qualified clients. Alvotech aims to be a global leader in biosimilar medicine, with a pipeline of eight candidates targeting various diseases. The company emphasizes that this communication does not constitute an offer to sell securities in the U.S.

Alvotech and STADA have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT04, a proposed biosimilar to Stelara (ustekinumab). This milestone could lead to a recommendation for approval by the EMA in the second half of 2023. AVT04 aims to provide an affordable treatment option for various inflammatory conditions. The partnership has previously launched high-concentration adalimumab in 16 countries. Alvotech's comprehensive biosimilar platform supports the development of multiple products, enhancing accessibility to biologic medicines across Europe.