Vir Biotechnology, Inc. - VIR STOCK NEWS

Vir Biotechnology (Nasdaq: VIR) has announced it will provide a corporate update and report its fourth quarter and full year 2024 financial results on February 26, 2025. The announcement will be made after market close, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET.

The financial results and corporate update will be accessible through a press release on the company's website's Investors section. Interested parties can join the conference call via webcast or by phone using the U.S. toll-free number +1 (888) 800-8770 or international number +1 (646) 307-1953, with Conference ID: 7568777. A recording will be available approximately two hours after the event and archived for 30 days.

Vir Biotechnology has announced promising Phase 1 data for two dual-masked T-cell engagers: VIR-5818 for HER2-expressing solid tumors and VIR-5500 for metastatic castration-resistant prostate cancer (mCRPC).

For VIR-5818, tumor shrinkage was observed in 50% (10/20) of participants receiving doses ≥400 µg/kg, with confirmed partial responses in 33% (2/6) of HER2-positive colorectal cancer patients. VIR-5500 showed PSA declines in 100% (12/12) of mCRPC patients, with PSA50 response confirmed in 58% (7/12) of patients receiving first doses ≥120 µg/kg.

Both treatments demonstrated promising safety profiles with no dose-limiting cytokine release syndrome (CRS) and maximum tolerated dose not yet reached. The PRO-XTEN™ masking technology showed minimal systemic unmasking, potentially enabling selective activation in tumor microenvironment and reducing toxicity.

Vir Biotechnology (NASDAQ: VIR) has announced that CEO Marianne De Backer will deliver a presentation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Tuesday, January 14, at 4:30 p.m. PT.

Interested parties can access a live webcast of the presentation through the Events & Presentations section of Vir's investor relations website at www.vir.bio. The webcast recording will remain available on the website for 30 days following the presentation.

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.