Welcome to our dedicated page for Vir Biotechnology news (Ticker: VIR), a resource for investors and traders seeking the latest updates and insights on Vir Biotechnology stock.
Vir Biotechnology, Inc. (Nasdaq: VIR) is a clinical-stage biopharmaceutical company developing immune-based medicines for serious infectious diseases and cancer, and its news flow reflects active clinical and corporate development. Company announcements highlight progress in chronic hepatitis delta (CHD), where Vir Biotechnology is advancing a combination of tobevibart, an investigational broadly neutralizing monoclonal antibody targeting hepatitis B surface antigen, and elebsiran, an investigational hepatitis B virus-targeting siRNA, through the ECLIPSE registrational program.
News updates frequently cover clinical data readouts and milestones, such as Phase 2 SOLSTICE trial results in CHD showing rates of undetectable hepatitis delta virus RNA and safety findings for the tobevibart and elebsiran combination. Additional releases describe enrollment status and timelines for the ECLIPSE 1, 2 and 3 trials, which are designed to provide efficacy and safety data for potential regulatory submissions and to support access and reimbursement in key markets.
Vir Biotechnology also issues news on its oncology portfolio of PRO-XTEN dual-masked T-cell engagers, including VIR-5500 in metastatic castration-resistant prostate cancer, VIR-5818 in HER2-expressing tumors and VIR-5525 in EGFR-expressing solid tumors. These updates may include first-patient-dosed announcements, Phase 1 dose escalation progress, and plans to present safety and efficacy data at scientific meetings.
Corporate and financial communications, such as quarterly results, conference presentations and licensing agreements, also feature prominently. For example, the company has reported on a license agreement with Norgine for CHD commercial rights in Europe, Australia and New Zealand and has provided guidance on its cash runway. Investors and followers of VIR news can use this page to monitor clinical milestones, regulatory-related updates, partnering activity and financial disclosures as the company advances its infectious disease and oncology programs.
Vir Biotechnology (NASDAQ: VIR) has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The company's CEO, Marianne De Backer, M.Sc., Ph.D., MBA, is scheduled to take part in a fireside chat on Thursday, September 5, at 1:50 p.m. PT / 4:50 p.m. ET in New York City.
Investors and interested parties can access a live webcast of the fireside chat through the Events & Presentations section of Vir Biotechnology's website at www.vir.bio. The webcast will remain archived on the site for 30 days following the event, allowing those unable to attend the live session to catch up on the discussion.
Vir Biotechnology (Nasdaq: VIR) reported Q2 2024 financial results and announced a strategic restructuring. Key highlights include:
1. Positive preliminary Phase 2 data for chronic hepatitis delta treatment
2. FDA IND clearance and Fast Track Designation for tobevibart and elebsiran
3. Exclusive license agreement with Sanofi
4. Strategic workforce restructuring, reducing headcount by 25%
5. $1.43 billion in cash and investments as of June 30, 2024
6. Q2 2024 revenues of $3.1 million, down from $3.8 million in Q2 2023
7. Net loss of $(138.4) million, or $(1.02) per share
8. Lowered full-year 2024 operating expense guidance to $580-$610 million
Vir Biotechnology (Nasdaq: VIR) has entered 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. The deal includes SAR446309 (HER2-targeted), SAR446329 (PSMA-targeted), and SAR446368 (EGFR-targeted) TCEs. This strategic move aligns with Vir's mission of powering the immune system and aims to address treatment-associated toxicity in cancer therapeutics.
The proprietary masking platform potentially increases the therapeutic index and mitigates toxicities associated with systemic immune activation. Key employees with expertise in TCEs will join Vir upon regulatory clearance. Vir will make an upfront payment to Sanofi, which is also eligible for future milestone payments and tiered royalties on worldwide net sales.
Vir Biotechnology (Nasdaq: VIR) has announced that it will release its second quarter 2024 financial results 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 the same day to discuss the results. Investors can access the financial results via a press release that will be available on the company's website after market close. The conference call can be accessed through a webcast on Vir's website or by dialing in using the provided toll-free numbers. A recorded version of the call will be available on the website approximately two hours after the event and will be archived for 30 days.
Vir Biotechnology (Nasdaq: VIR) has received FDA clearance for its IND application and Fast Track designation for its combination treatment of tobevibart and elebsiran aimed at chronic hepatitis delta infection. The IND clearance follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024. The Phase 2 SOLSTICE trial data showed high rates of virologic response and ALT normalization at 12 and 24 weeks, with complete 24-week data expected in Q4. This Fast Track designation will facilitate the expedited review and development of this promising treatment. Hepatitis delta, considered the most severe form of chronic viral hepatitis by the WHO, affects over 12 million people globally. Vir plans to initiate its ECLIPSE trial soon, which will support potential registration of the treatment.
Vir Biotechnology announced promising preliminary phase 2 data from its SOLSTICE trial for hepatitis delta treatment. The study evaluates tobevibart, a monoclonal antibody, and elebsiran, a small interfering RNA, as monotherapy and combination therapy.
Key findings include high virologic response rates and ALT normalization at 12 and 24 weeks. Combination therapy showed 100% virologic response at both 12 and 24 weeks, while tobevibart monotherapy had 73% and 55% at these intervals. Most adverse events were mild and transient without serious occurrences.
Further data will be presented at the EASL Congress 2024, with a conference call scheduled for June 5, 2024.
Vir Biotechnology (Nasdaq: VIR) announced CEO Marianne De Backer will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference. The event is scheduled for June 12 at 11:00 a.m. PT / 2:00 p.m. ET at the Loews Miami Beach Hotel. The discussion will be webcast live and archived for 30 days on the Vir website.
Vir Biotechnology announced the appointment of Mark D. Eisner, M.D., M.P.H. as Executive Vice President and Chief Medical Officer (CMO), effective June 03, 2024. Dr. Eisner brings over 32 years of experience in biotech, with deep expertise in immunology and infectious diseases. He previously held the CMO position at Sonoma Biotherapeutics and FibroGen, and served as Senior Vice President at Genentech, leading late-stage clinical development across multiple therapeutic areas. Dr. Eisner's role at Vir will involve overseeing clinical development programs and contributing to the company's growth by advancing medicines for unmet medical needs.
Vir Biotechnology (Nasdaq: VIR) will hold its 2024 Annual Meeting of Stockholders on May 29, 2024, at 9:00 a.m. PT. The meeting will be conducted virtually via live audio webcast. Stockholders of record at the close of business on April 1, 2024, are eligible to attend and vote. Participants can access the meeting through the provided web link using their control number. Online access will begin at 8:45 a.m. PT on the day of the meeting. Vir Biotechnology encourages all stockholders to vote and submit their proxies in advance.
Vir Biotechnology announced that three abstracts focusing on chronic hepatitis delta and hepatitis B will be presented at the EASL Congress 2024 in Milan from June 5-8.
The presentations include new data from the Phase 2 SOLSTICE trial, evaluating the safety and efficacy of tobevibart and elebsiran in chronic hepatitis delta patients.
Key highlights include 12 and 24-week treatment data, as well as 48-week data for a subset of participants.
Additional 24-week data on all 60 participants will be reported in Q4 2024. An investor conference call is scheduled for June 5 to discuss these findings.