Vir Biotechnology, Inc. Stock Price, News & Analysis

Vir Biotechnology (Nasdaq: VIR) has announced the successful initiation of all trials in its ECLIPSE registrational program for chronic hepatitis delta (CHD) with the enrollment of the first participant in ECLIPSE 3. The Phase 2b ECLIPSE 3 trial will evaluate the combination of tobevibart and elebsiran compared to bulevirtide in CHD patients.

The combination therapy has received multiple regulatory designations including Breakthrough Therapy and Fast Track from the FDA, and PRIME and orphan drug status from the EMA. The treatment aims to eliminate the virus through multiple mechanisms, addressing an urgent unmet medical need in CHD, which is the most severe form of chronic viral hepatitis with no approved treatments in the U.S.

Vir Biotechnology (Nasdaq: VIR) has initiated ECLIPSE 2, a pivotal Phase 3 clinical trial for chronic hepatitis delta (CHD). The trial will evaluate the combination of tobevibart and elebsiran versus continued bulevirtide monotherapy in patients who haven't achieved undetectable hepatitis delta virus RNA with bulevirtide treatment.

ECLIPSE 2 is part of Vir's global ECLIPSE registrational program launched in March 2025, designed to support marketing applications in the U.S. and Europe. The combination therapy has received multiple regulatory designations, including FDA Breakthrough Therapy and Fast Track, and EMA PRIME and orphan drug designations.

Vir Biotechnology (Nasdaq: VIR) has initiated dosing in a Phase 1 clinical trial for VIR-5525, their third dual-masked T-cell engager targeting EGFR for solid tumors. The trial will evaluate the treatment in multiple cancer types including NSCLC, colorectal cancer, HNSCC, and cSCC.

The study will assess VIR-5525 both as monotherapy and in combination with pembrolizumab. The drug leverages the PRO-XTEN™ masking technology to selectively activate in tumor environments, potentially reducing toxicity. The first patient dosing triggers a $75 million milestone payment from Sanofi under their 2024 licensing agreement.

Additionally, the company reported continued dose escalation for their other dual-masked TCEs (VIR-5818 for HER2 and VIR-5500 for PSMA), with promising early clinical responses and safety data from January 2025.

Vir Biotechnology (Nasdaq: VIR) has scheduled its second quarter 2025 financial results announcement and corporate update for August 6, 2025. The company will release its financial results and corporate update via press release after market close, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET.

Investors can access the conference call through a webcast on Vir's website or by phone using the 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 (VIR) announced that its CEO Marianne De Backer will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference 2025. The event is scheduled for June 10 at 1:00 p.m. PT / 4:00 p.m. ET in Miami Beach, Florida. A live webcast of the discussion will be available in the Investors section of Vir's website under Events & Presentations and will remain archived for 30 days.

Vir Biotechnology (VIR) announced that CEO Marianne De Backer and EVP Mika Kakefuda Derynck will participate in a virtual fireside chat at the TD Cowen 6th Annual Oncology Innovation Summit on May 27, 2025, at 1:30 PM PT / 4:30 PM ET. The event will be accessible via webcast in the Investors section of Vir's website under Events & Presentations and will remain archived for 30 days.

Vir Biotechnology (VIR) announced that CEO Marianne De Backer will participate in a fireside chat at the Bank of America Securities 2025 Healthcare Conference. The event is scheduled for Wednesday, May 14 at 1:40 p.m. PT / 4:40 p.m. ET in Las Vegas, Nevada. Investors can access a live webcast of the presentation through the Events & Presentations section of Vir's website, where it will remain archived for 30 days.

Vir Biotechnology (VIR) has announced 24-week post-treatment data from the MARCH Phase 2 study evaluating tobevibart and elebsiran combinations for chronic hepatitis B (CHB). The study showed that 17% and 21% of participants with low baseline HBsAg levels achieved HBsAg loss when treated with tobevibart + elebsiran without or with PEG-IFNα, respectively. Functional cure rates were 11% and 15% in low baseline HBsAg participants. The treatment combinations demonstrated good safety profiles with mostly mild to moderate adverse events. However, Vir announced it will not proceed with Phase 3 development without a global development partner, which hasn't been secured. The company plans to streamline the final stages of the MARCH Phase 2 study while maintaining its cash runway guidance into mid-2027. Vir remains committed to developing these treatments for chronic hepatitis delta.

Vir Biotechnology (VIR) reported Q1 2025 financial results and provided key pipeline updates. The company enrolled its first patient in the Phase 3 ECLIPSE program for chronic hepatitis delta, which received FDA Breakthrough and Fast Track designations. Vir continues dose escalation for its dual-masked T-cell engagers VIR-5818 (HER2) and VIR-5500 (PSMA), with promising early results showing tumor shrinkage in 50% of participants for VIR-5818 and PSA reductions in 100% of prostate cancer patients for VIR-5500. The company plans to initiate a Phase 1 study of VIR-5525 (EGFR) in Q2 2025. Financially, Vir reported $1.02 billion in cash and investments, a net loss of $121.0 million ($0.88 per share), and revenues of $3.0 million. R&D expenses increased to $118.6 million, while SG&A expenses decreased to $23.9 million. The company expects its current cash position to fund operations into mid-2027.