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) announced it will present new data from the Phase 2 SOLSTICE clinical trial evaluating tobevibart and elebsiran for the potential treatment of chronic hepatitis delta at AASLD's The Liver Meeting® 2024. The company will present an oral presentation on the Week 24 primary endpoint analysis of the SOLSTICE trial, along with five poster presentations.
The posters will cover topics including:
- Pharmacokinetics and safety of elebsiran in participants with moderate renal impairment
- Dose-dependent effects of tobevibart on Hepatitis B Surface Antigen composition
- Safety profile of tobevibart and elebsiran for chronic hepatitis B and delta
- Evidence supporting surrogate endpoints and fibroscan in hepatitis D infection
- Economic burden among HDV-infected patient segments
These presentations aim to highlight progress in Vir's hepatitis delta and hepatitis B clinical programs, as well as provide insights into disease burden.
Vir Biotechnology, Inc. (NASDAQ:VIR) has announced that Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, will participate in a fireside chat at the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference. The event is scheduled for Tuesday, October 8, at 10:00 a.m. PT / 1:00 p.m. ET.
A live webcast of the fireside chat will be available under the Events & Presentations section in the Investors area of the Vir website at www.vir.bio. The webcast will remain archived on the site for 30 days following the event.
Vir Biotechnology (Nasdaq: VIR) has appointed Jason O'Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024. O'Byrne brings over 20 years of experience in finance and operations to Vir. He joins from Caribou Biosciences, where he served as CFO, and previously held senior roles at Audentes Therapeutics and Genentech. O'Byrne's expertise spans capital allocation, corporate strategy, and operational execution.
CEO Marianne De Backer praised O'Byrne's exceptional leadership and proven track record in financial strategy across public companies. O'Byrne expressed excitement about joining Vir as it expands into oncology and continues work in infectious diseases. His appointment aims to support Vir's mission of advancing innovative antibody therapeutics.
Vir Biotechnology (Nasdaq: VIR) has closed its exclusive worldwide license agreement with Sanofi, initially announced on August 1, 2024. This strategic deal grants Vir exclusive rights to three clinical-stage masked T-cell engagers (TCEs) and the PRO-XTEN masking platform for oncology and infectious disease applications. The agreement includes:
1. SAR446309: A dual-masked HER2-targeted TCE in phase 1 for metastatic HER2+ tumors.
2. SAR446329: A dual-masked PSMA-targeted TCE in phase 1 for metastatic castration-resistant prostate cancer.
3. SAR446368: A dual-masked EGFR-targeted TCE with an active IND, phase 1 study expected to begin in Q1 2025.
Key Sanofi employees with TCE expertise will join Vir. The company plans to provide further details at its upcoming R&D Day in November.
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.