Vir Biotechnology, Inc. - VIR STOCK NEWS

Vir Biotechnology (VIR) has received FDA Breakthrough Therapy designation and EMA PRIME designation for its combination therapy of tobevibart and elebsiran in treating chronic hepatitis delta (CHD). These designations are based on positive safety and efficacy data from the Phase 2 SOLSTICE trial.

The company plans to initiate its Phase 3 ECLIPSE registrational program in the first half of 2025. CHD, the most severe form of chronic viral hepatitis, currently has no approved treatment in the U.S. and options globally. The Phase 2 trial data showed the combination therapy's ability to rapidly suppress the hepatitis delta virus to undetectable levels.

These new designations aim to expedite development and regulatory reviews, following earlier FDA Fast Track designation and EMA orphan drug designation.

Vir Biotechnology (NASDAQ:VIR) has announced a virtual investor event scheduled for January 8, 2025, at 5:00 a.m. PT / 8:00 a.m. ET. The event will present initial data from two Phase 1 T-cell engager programs: VIR-5818, targeting HER2-expressing solid tumors, and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC). Updates on the PRO-XTEN™ platform will also be discussed. The presentation will be accessible via webcast on the company's investor relations website and archived for 30 days.

Vir Biotechnology (NASDAQ: VIR) has announced that its CEO Marianne De Backer will participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference in Miami, Florida. The event is scheduled for Tuesday, December 3, at 6:10 a.m. PT / 9:10 a.m. ET. A live webcast of the discussion will be available on the company's website under the Investors section and will remain accessible for 30 days following the event.

Vir Biotechnology (NASDAQ:VIR) announced positive results from the SOLSTICE Phase 2 clinical trial evaluating tobevibart and elebsiran combination for chronic hepatitis delta (CHD). The treatment achieved 100% virologic response with HDV RNA suppression, showing undetectable virus levels in 41% of participants at Week 24, increasing to 64% by Week 36, and reaching 80% by Week 60. The combination therapy demonstrated a strong safety profile with no severe treatment-related adverse events. Based on these results, Vir plans to initiate the Phase 3 ECLIPSE registrational program in early 2025, comprising three clinical trials to evaluate the combination therapy against existing treatments.

Vir Biotechnology (VIR) has received a positive opinion from the European Medicines Agency's Committee for Orphan Medicinal Products for orphan drug designation of tobevibart and elebsiran in treating chronic hepatitis delta (CHD). The opinion follows encouraging preliminary data from the Phase 2 SOLSTICE trial, with 24-week data to be presented at AASLD The Liver Meeting. This development comes after receiving FDA fast track designation in June 2024. CHD is considered the most aggressive form of chronic viral hepatitis, with patients often progressing to cirrhosis within 5 years. The orphan designation could provide 10 years of market exclusivity in the EU upon approval.

Vir Biotechnology announced positive end-of-treatment results from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran for chronic hepatitis B treatment. The study showed promising HBsAg loss rates, with 39% of participants achieving HBsAg loss with the doublet regimen and 46% with the triplet regimen (including pegylated interferon alfa) in patients with low baseline HBsAg. No new safety concerns were identified, with treatment-emergent adverse events being generally mild to moderate. Key functional cure data from 24-week follow-up is expected in Q2 2025.

Vir Biotechnology reported Q3 2024 financial results, highlighting a transformational quarter marked by the closing of an exclusive worldwide licensing agreement with Sanofi for three clinical-stage dual-masked T-cell engagers. The company reported a net loss of $(213.7) million, or $(1.56) per share. Total revenues were $2.4 million, with cash and investments of $1.19 billion. Key developments include promising Phase 2 SOLSTICE data in chronic hepatitis delta, appointment of Jason O'Byrne as CFO, and a strategic restructuring reducing workforce by 25%. The company updated its GAAP operating expense guidance to $660-680 million for 2024.

Vir Biotechnology (Nasdaq: VIR) has announced that it will provide a corporate update and report its third quarter 2024 financial results 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 the same day. The financial results and corporate update will be released via a press release after market close and will be accessible on the company's website. Interested parties can join the conference call through a webcast or by dialing in. 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) 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.