Vir Biotechnology, Inc. - Common Stock (VIR)

Vir Biotechnology Inc. (NASDAQVIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, at 4:30 p.m. PT in San Francisco, California.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting® in San Diego, U.S. Vir Biotechnology’s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.

Vir Biotechnology, Inc. (NASDAQVIR) today announced it will host a virtual investor event to discuss initial data from the dual-masked Phase 1 T-cell engagers VIR-5818 targeting a variety of HER2-expressing solid tumors and VIR-5500 targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC) along with updates on the PRO-XTEN™ platform on January 8, 2025, at 5:00 a.m. PT / 8:00 a.m. ET.

Vir Biotechnology Inc. (NASDAQVIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, is scheduled to participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on Tuesday December 3, at 6:10 a.m. PT / 9:10 a.m. ET in Miami, Florida.

Vir Biotechnology, Inc. (NASDAQVIR) today announced positive results from the SOLSTICE Phase 2 clinical trial evaluating tobevibart alone, or in combination with elebsiran, in people with chronic hepatitis delta (CHD). The most-advanced and potential first-of-its-kind investigational human monoclonal antibody and siRNA combination dosed monthly achieved 100% virologic response and rapid hepatitis delta virus (HDV) RNA suppression. HDV RNA below the lower limit of quantification (< LLOQ), target not detected (TND), the best measure that the virus is cleared from the body, was achieved in 41% (13/32) of participants at Week 24 rising to 64% (14/22) of participants by Week 36. In a cohort that reached Week 60, 80% (4/5) achieved HDV RNA TND.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD). This opinion is based on encouraging preliminary data from the Phase 2 SOLSTICE trial. Vir Biotechnology will present 24-week data from the Phase 2 SOLSTICE trial at AASLD The Liver Meeting® in San Diego, CA, on November 18 at 6.15 p.m. PT. An investor conference call is scheduled for November 19, 2024, at 5.15 a.m. PT / 8.15 a.m. ET.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced end-of-treatment data from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, with or without pegylated interferon alfa (PEG-IFNα), in participants with chronic hepatitis B. The study demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens. The efficacy and safety profile support continued development to evaluate the potential to achieve a functional cure. Detailed data will be presented in a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, in San Diego, CA, on November 18 at 5:00 p.m. PT. Vir Biotechnology will host an investor conference call on November 19, at 5.15 a.m. PT / 8.15 a.m. ET.

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the third quarter ended September 30, 2024.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the Company will provide a corporate update and report financial results for the third quarter ended September 30, 2024, on October 31, 2024. The Company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on October 31, 2024.

Vir Biotechnology, Inc. (NASDAQVIR) today announced it will present new data from the Phase 2 SOLSTICE clinical trial evaluating the efficacy and safety profile of tobevibart, an investigational monoclonal antibody (mAb), and elebsiran, an investigational small interfering ribonucleic acid (siRNA) for the potential treatment of chronic hepatitis delta.

Vir Biotechnology, Inc. (NASDAQVIR) today announced that Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, is scheduled to participate in a fireside chat at the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference on Tuesday, October 8, at 10:00 a.m. PT / 1:00 p.m. ET.

Vir Biotechnology Inc. (Nasdaq: VIR) today announced that Jason O’Byrne, MBA, is appointed as Executive Vice President and Chief Financial Officer (CFO), effective October 2, 2024. Mr. O’Byrne will join the Vir Executive Management Team and report directly to the company’s Chief Executive Officer, Marianne De Backer, M.Sc., Ph.D., MBA.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The agreement provides Vir with an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers and exclusive use of the proprietary PRO-XTENTM masking platform for oncology and infectious disease. Key employees from Sanofi with extensive scientific and development expertise in TCEs, and in-depth experience using the PRO-XTEN platform, will join Vir. Further information about the TCEs and their respective development plans will be provided at Vir’s upcoming R&D Day in November.

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Vir Biotechnology Inc. (NASDAQVIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer is scheduled to participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on Thursday, September 5, at 1:50 p.m. PT / 4:50 p.m. ET in New York City.

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2024.

PALM BEACH, Fla., Sept. 04, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The emergence of SARS-CoV-2, which triggered the COVID-19 pandemic with overall is widely regarded as the greatest medical emergency of the twentieth century. COVID-19’s impact on global society would be felt for a long time. Nonetheless, significant investment in life sciences in the last few decades has facilitated a rapid scientific response through advances in viral characterization, testing, and sequencing. A report from Transparency Market Research projects that the global COVID-19 therapeutics market size is projected to reach more than US$ 16.2 Bn by the end of 2031. The report continued: “The coronavirus treatment, and vaccination market witnessed significant increase in demand due to the desire of governments and people to safeguard themselves and their loved ones from the virus. Technology advancements have facilitated the rapid development of COVID medications therapies and vaccinations. In a relatively short amount of time, emerging technologies, such as CRISPR and mRNA, have made it possible to develop new medicines. Pharmaceutical corporations, biotech companies, academic institutions, and governmental entities have worked closely together to create COVID-19 treatments. New therapies and vaccines have been developed and distributed more rapidly because of this collaboration.” Active companies in the biotech industry this week include Sunshine Biopharma Inc. (NASDAQSBFM), Moderna, Inc. NASDAQ: MRNANASDAQMRNA)(NYSE: PFENYSEPFE, Vir Biotechnology, Inc. (NASDAQ: VIRNASDAQ), INOVIO (NASDAQ: INOINO).

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals. The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the Company will provide financial results for the second quarter ended June 30, 2024, on August 1, 2024. The Company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on August 1, 2024.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, for the treatment of people living with chronic hepatitis delta. Preliminary data from the Phase 2 trial show treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer is scheduled to participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, at 11:00 a.m. PT / 2:00 p.m. ET at the Loews Miami Beach Hotel, Miami Beach, Florida.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that Mark D. Eisner, M.D., M.P.H. will join the company as Executive Vice President and Chief Medical Officer (CMO), effective June 03, 2024. Dr. Eisner will be a part of the company’s Executive Management Team and will report directly to Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

Vir Biotechnology, Inc. (Nasdaq: VIR) today reminds stockholders that it will hold its 2024 Annual Meeting of Stockholders on Wednesday, May 29, 2024, at 9:00 a.m. PT. The Annual Meeting will be held in virtual format only via live audio webcast.

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that three abstracts highlighting new data from the Company’s chronic hepatitis delta and chronic hepatitis B programs have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2024, taking place in Milan, Italy from June 5-8. This includes an oral presentation on June 8, which was originally accepted as a late-breaker poster, that will highlight the Company’s latest Phase 2 SOLSTICE trial data. The Company also plans to host an investor conference call on June 5 at 6:00 a.m. ET / 12:00 p.m. CEST to discuss the data.