Vir Biotechnology, Inc. Stock Price, News & Analysis

The latest data from the Phase 3 COMET-ICE trial shows that sotrovimab significantly decreases the risk of hospitalization and death in high-risk adults with mild-to-moderate COVID-19 by 79%. This finding led the NIH to update its COVID-19 treatment guidelines, now endorsing sotrovimab for high-risk patients. The trial included 1,057 patients, with only 1% in the sotrovimab arm hospitalized compared to 6% in placebo. The companies aim to submit full data for peer review and pursue broader access, including an intramuscular formulation for easier administration.

Vir Biotechnology announced acceptance of four abstracts from its hepatitis B clinical program for presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress, taking place virtually June 23-26, 2021. The company will host a conference call on June 25, 2021, to discuss the new data. Key presentations will focus on VIR-2218 and VIR-3434, investigational therapies targeting chronic hepatitis B. Vir aims to enhance immune responses and antiviral activity against HBV.

Vir Biotechnology will participate in a virtual fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, 2021, at 12:00 pm PT / 3:00 pm ET. The presentation will be led by CEO George Scangos, Ph.D.

A live webcast can be accessed via the Investors section of the Vir website and will be archived for 30 days post-event. The company utilizes its website for disclosing material non-public information, encouraging investors to monitor updates regularly.

Vir focuses on innovative treatments for serious infectious diseases through robust immunologic technologies.

Sotrovimab, an investigational monoclonal antibody by GSK and Vir, received FDA Emergency Use Authorization for treating mild-to-moderate COVID-19 in high-risk adults and pediatric patients. Phase 3 COMET-ICE trial showed an 85% reduction in hospitalization or death risk compared to placebo. In vitro studies confirm effectiveness against all known SARS-CoV-2 variants. Availability to patients is expected soon, with ongoing discussions for global regulatory approval. The EUA submission highlighted minor adverse events, emphasizing Sotrovimab's critical role in COVID-19 treatment.

The European Medicines Agency’s CHMP has provided a positive scientific opinion regarding the early treatment of COVID-19 with sotrovimab (previously VIR-7831). This opinion permits EU member states to consider early use of the drug prior to formal EMA marketing authorization. The opinion followed a review of the Phase 3 COMET-ICE trial, which showed an 85% reduction in hospitalization or death among treated patients. Discussions with regulators in other countries for potential authorizations are ongoing, emphasizing the urgency of effective COVID-19 treatments amid rising variants.

Vir Biotechnology and GlaxoSmithKline announced a positive scientific opinion from the EMA’s Committee for Human Medicinal Products for sotrovimab, a treatment for COVID-19, particularly in adults and adolescents at risk of severe disease. EU member states can utilize this opinion for early use decisions before formal marketing authorization. Sotrovimab is set to be available for patients in the U.S. soon. The CHMP's decision was based on an interim analysis from the Phase 3 COMET-ICE trial, demonstrating an 85% reduction in hospitalization or death, highlighting its efficacy against evolving COVID-19 variants.

Vir Biotechnology (Nasdaq: VIR) will hold its 2021 Annual General Meeting of Stockholders on May 20, 2021, at 11:30 a.m. PT, in a virtual format only. Stockholders of record as of March 22, 2021, can attend by accessing the meeting center online. Stockholders are encouraged to vote and submit their proxy ahead of the meeting. Vir Biotechnology specializes in immunology, focusing on solutions for serious infectious diseases, with a pipeline targeting COVID-19, hepatitis B, influenza A, and HIV.

Vir Biotechnology and GSK announced that the European Medicines Agency (EMA) has initiated a rolling review of sotrovimab, an investigational monoclonal antibody for treating COVID-19 in high-risk adults and adolescents. This review supports an upcoming Marketing Authorization Application. The EMA's assessment will consider data, including interim analyses from the Phase 3 COMET-ICE trial, where sotrovimab showed an 85% reduction in hospitalizations compared to placebo. The review process aims to expedite the authorization of sotrovimab for COVID-19 treatment.

Vir Biotechnology reported first-quarter results as of March 31, 2021, noting total revenues of $2 million, a decrease from $5.7 million in Q1 2020. Research and development expenses surged to $134.9 million, reflecting costs for COVID-19 programs, particularly VIR-7831 and VIR-2218. The net loss widened to $168.9 million, or $1.32 per share, compared to $77.2 million, or $0.71 per share, in the previous year. The company holds $733 million in cash and equivalents, bolstered by a recent equity sale to GSK. Upcoming trials and regulatory submissions highlight ongoing efforts to combat COVID-19.