Alvotech Stock Price, News & Analysis

Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA filing acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.

The announcement follows positive top-line results from a confirmatory clinical study in April 2024 comparing AVT05 with Simponi® in rheumatoid arthritis patients, and successful pharmacokinetic study results from November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now includes nine biosimilar products. The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024.

Alvotech (NASDAQ: ALVO) announced its addition to the Nasdaq Biotechnology Index (NBI), effective December 23, 2024, as part of the index's annual reconstitution. The inclusion reflects Alvotech's meeting of eligibility requirements, including minimum market capitalization and average daily trading volume criteria. The NBI comprises Nasdaq-listed companies classified as Biotechnology or Pharmaceuticals according to the Industry Classification Benchmark and is calculated using a modified capitalization-weighted methodology.

Senti Biosciences (SNTI) announced the first patient dosing in a clinical trial of SN301A for hepatocellular carcinoma (HCC) in mainland China, in collaboration with Celest Therapeutics. The trial aims to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of SN301A, a CAR-NK cell therapy utilizing Senti's Gene Circuit platform, in patients with advanced GPC3-expressing HCC across multiple dose cohorts.

Celest is leading the clinical development, operations, and manufacturing in China, with Senti Bio providing technical and strategic input. The study will assess adverse events, dose-limiting toxicities, and efficacy using standard liver cancer response criteria. The collaboration may expand to Hong Kong, Macau, and Taiwan, while Senti Bio retains rights outside these regions.

Dominion Energy (NYSE: D) announced that Diane Leopold, Executive Vice President and Chief Operating Officer, will retire on June 1, 2025, after a 36-year career in energy, including 30 years at Dominion. During the transition, Ed Baine will become President-Utility Operations and Dominion Energy Virginia, while Eric Carr will become Chief Nuclear Officer and President-Nuclear Operations and Contracted Energy. Leopold will maintain oversight of major construction projects including the Coastal Virginia Offshore Wind project and Charybdis. She joined Dominion in 1995, became an officer in 2004, and has held various executive roles before assuming her current position in 2020.

Lazydays Holdings (Nasdaq: GORV) reported challenging Q3 2024 results with total revenue declining to $213.5 million from $280.7 million in Q3 2023. The company posted a net loss of $17.7 million ($1.37 per diluted share) compared to a $5.6 million loss in Q3 2023. For the nine months ended September 30, 2024, revenue decreased to $722.7 million from $884.7 million, with a net loss of $83.9 million. The company recently completed recapitalization transactions to strengthen its financial foundation, streamline its balance sheet, and enhance liquidity.

Alvotech (NASDAQ: ALVO) reported strong financial results for the first nine months of 2024. Total revenues increased by $300 million to $339 million compared to 2023. Product revenues grew over four-fold to $128 million, while license and other revenues rose by $203 million to $211 million. The company achieved positive adjusted EBITDA of $87 million, compared to negative $225 million in 2023. Marketing applications were accepted in Europe for biosimilar candidates to Prolia®/Xgeva® and Simponi®. The company initiated a confirmatory clinical study for AVT16, a biosimilar candidate to Entyvio®.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, announced its participation in two upcoming healthcare conferences. The company will attend Citi's Global Healthcare Conference in Miami on December 4, 2024, and Evercore's HealthCONx Conference in Coral Gables on December 5, 2024. Management will conduct one-on-one meetings at both events and participate in a fire-side chat at Evercore's conference at 12:55 ET. A live audio webcast of the fire-side chat will be available to investors through Alvotech's website, with the recording accessible for 90 days post-event.

Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi® (golimumab). This marks the first globally announced marketing authorization application for a Simponi biosimilar candidate. The approval process is expected to complete in Q4 2025.

The companies expanded their partnership in May to include AVT05 and other biosimilar candidates. Positive results from both a confirmatory clinical study in rheumatoid arthritis patients and a pharmacokinetic study in healthy participants were previously announced in April 2024 and November 2023, respectively.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its financial results release for the first nine months of 2024. The results will be announced after U.S. markets close on November 13, 2024, followed by an analyst conference call on November 14, 2024, at 8:00 am ET. The conference call will be accessible via webcast through Alvotech's investor portal, with replay available for 90 days after the event.