This section highlights FDA-related milestones and regulatory updates for drugs developed by Vir Biotechnology (VIR).
Over the past two years, Vir Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
tobevibart, Tobevibart, VIR-3434, VIR-5818, and XTEN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
tobevibart - FDA Regulatory Timeline and Events
tobevibart is a drug developed by Vir Biotechnology for the following indication: For Chronic Hepatitis Delta.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- tobevibart
- Announced Date:
- March 13, 2025
- Indication:
- For Chronic Hepatitis Delta
Announcement
Vir Biotechnology, Inc announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program.
AI Summary
Vir Biotechnology recently announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program. This program is designed to evaluate the safety and effectiveness of tobevibart in combination with elebsiran for patients with chronic hepatitis delta, a serious liver disease. The ECLIPSE 1 trial is the first of its kind in a series of studies meant to gather the crucial data needed for regulatory submissions and to improve patient access to this potential new treatment.
The study aims to show that the combination therapy can rapidly reduce hepatitis delta virus levels and possibly improve liver function. This early patient enrollment marks an important milestone, emphasizing the urgent need for more effective treatment options. Vir Biotechnology’s efficient study start reflects its commitment to addressing the significant unmet medical need in chronic hepatitis delta treatment.
Read Announcement
Tobevibart and Elebsiran - FDA Regulatory Timeline and Events
Tobevibart and Elebsiran is a drug developed by Vir Biotechnology for the following indication: For the Treatment of Chronic Hepatitis Delta Infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- May 9, 2025
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc. announced 24-week post-end of treatment data from Part B of the ongoing MARCH Phase 2 clinical study evaluating tobevibart and elebsiran without or with pegylated interferon alpha (PEG-IFNα) in participants with chronic hepatitis B (CHB).
AI Summary
Vir Biotechnology, Inc. announced new 24‐week post-end-of-treatment results from Part B of its ongoing MARCH Phase 2 clinical study in patients with chronic hepatitis B (CHB). The trial evaluated the combination of tobevibart and elebsiran, both with and without pegylated interferon alpha (PEG-IFNα). In a subgroup of participants with low baseline hepatitis B surface antigen (HBsAg) levels, 17% of those receiving the combination without PEG-IFNα and 21% of those receiving it with PEG-IFNα achieved HBsAg loss 24 weeks after treatment ended. The encouraging data, presented at the European Association for the Study of the Liver congress in Amsterdam, indicate that these regimens can help reduce HBsAg levels and offer potential benefits for select CHB patients. Additionally, the safety profile was favorable, with only mild to moderate side effects observed throughout the study.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- December 12, 2024
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD).
AI Summary
Vir Biotechnology, Inc. recently announced that its investigational treatments, tobevibart and elebsiran, have received U.S. FDA Breakthrough Therapy and European Medicines Agency (EMA) Priority Medicines (PRIME) designations for treating chronic hepatitis delta (CHD). These designations highlight the promising safety and efficacy data observed in the Phase 2 SOLSTICE trial, suggesting that the combination of these therapies can rapidly reduce viral levels to undetectable amounts. The FDA Breakthrough Therapy designation is meant to speed up the development and review process for treatments that show potential to offer significant benefits over existing options, while the EMA PRIME designation targets medicines addressing severe conditions with limited treatment choices.
The upcoming Phase 3 ECLIPSE registrational program for these treatments is set to begin in the first half of 2025, marking an important step forward in providing hope for patients with CHD.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- December 12, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc announced that The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting® in San Diego, U.S. Vir Biotechnology's Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.
AI Summary
Vir Biotechnology, Inc. announced that its therapies, tobevibart and elebsiran, have been granted U.S. FDA Breakthrough Therapy and European Medicines Agency Priority Medicines designations for treating chronic hepatitis delta. The designations were awarded based on strong safety and efficacy results from the Phase 2 SOLSTICE trial.
At AASLD The Liver Meeting® in San Diego, the company presented new data showing that the treatments can quickly and significantly reduce hepatitis delta virus levels. Building on these promising results, Vir Biotechnology plans to begin its Phase 3 ECLIPSE registrational program in the first half of 2025. This study aims to further evaluate the potential of tobevibart and elebsiran to address the serious unmet needs of patients suffering from chronic hepatitis delta.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- November 18, 2024
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD).
AI Summary
Vir Biotechnology, Inc. announced that the European Medicines Agency’s Committee for Orphan Medicinal Products has given a positive opinion for orphan drug designation for its treatments tobevibart and elebsiran. This designation supports the development of new therapies for serious illnesses like chronic hepatitis delta, a severe liver disease caused by the hepatitis delta virus. The positive opinion is based on promising early results from the Phase 2 SOLSTICE trial, highlighting the potential benefit of these therapies in improving patient outcomes. Orphan drug designation in the European Union offers several incentives, such as fee reductions, scientific advice, and up to 10 years of market exclusivity once approved. This news indicates a significant step toward addressing the unmet medical needs for patients suffering from chronic hepatitis delta and represents continued progress in the search for effective treatments for this life-threatening condition.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- June 26, 2024
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application
AI Summary
Vir Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for its combination treatment of tobevibart and elebsiran. This clearance also comes with Fast Track designation to help advance the therapy for chronic hepatitis delta infection. The Fast Track status is granted to drugs that address serious conditions with unmet medical needs, potentially speeding up the development and review processes.
The breakthrough marks an important step for Vir Biotechnology as it works to transform treatment options for a severe liver disease. The company is evaluating this treatment in its Phase 2 SOLSTICE trial, with full 24-week data expected later this year. Vir Biotechnology remains focused on collaborating closely with the FDA to move this promising therapy through further clinical testing and, ultimately, provide new options for patients in need.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- June 26, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc announced that Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.
AI Summary
Vir Biotechnology, Inc. announced that its Phase 2 SOLSTICE clinical trial for chronic hepatitis delta is progressing well. The trial is evaluating two investigational treatments, tobevibart and elebsiran, which are being tested either in combination or as monotherapy. The company expects to report complete 24-week treatment data during the fourth quarter, which could provide important information on how well these treatments work for patients with this serious liver condition.
The study is designed to check the safety and effectiveness of these treatments while also monitoring if they can help normalize liver-related markers in patients. The upcoming data release in the fourth quarter is highly anticipated and may play a key role in shaping how chronic hepatitis delta is managed in the future.
Read Announcement- Drug:
- Tobevibart and Elebsiran
- Announced Date:
- June 26, 2024
- Indication:
- For the Treatment of Chronic Hepatitis Delta Infection
Announcement
Vir Biotechnology, Inc announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection.
AI Summary
Vir Biotechnology, Inc. announced that the FDA has granted Fast Track designation for its investigational combination of tobevibart and elebsiran to treat chronic hepatitis delta infection. This designation is based on promising preliminary Phase 2 trial data and highlights the critical need for new treatments for this severe condition. The Fast Track status is meant to expedite the development and review process, potentially bringing this innovative therapy to patients more quickly. Vir Biotechnology is currently evaluating the combination in its SOLSTICE Phase 2 trial, with full 24-week treatment data expected later this year. The company emphasizes its commitment to collaborating with health authorities to meet the urgent medical need of patients with chronic hepatitis delta, a disease known for rapid progression towards liver cancer and increased mortality risk.
Read Announcement
VIR-3434 - FDA Regulatory Timeline and Events
VIR-3434 is a drug developed by Vir Biotechnology for the following indication: Chronic Hepatitis B virus infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VIR-3434
- Announced Date:
- May 22, 2024
- Indication:
- Chronic Hepatitis B virus infection
Announcement
Vir Biotechnology, Inc announced that three abstracts highlighting new data from the Company's chronic hepatitis delta and chronic hepatitis B programs have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2024, taking place in Milan, Italy from June 5-8.
AI Summary
Vir Biotechnology announced that three abstracts featuring new data from its chronic hepatitis delta and hepatitis B programs have been accepted for presentation at the annual European Association for the Study of the Liver (EASL™) Congress 2024. The event will take place in Milan, Italy from June 5 to 8. One highlight is an oral presentation scheduled for June 8 that will showcase updated results from the Phase 2 SOLSTICE trial, which is testing the safety, tolerability, and efficacy of tobevibart and elebsiran in people with chronic hepatitis delta.
The SOLSTICE trial data include findings from participants who have undergone 12 and 24 weeks of treatment, pointing to potential benefits for chronic hepatitis patients. This announcement emphasizes Vir Biotechnology’s commitment to developing transformative therapies for those affected by chronic hepatitis, addressing a significant unmet need in treating these viral infections.
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VIR-5818 - FDA Regulatory Timeline and Events
VIR-5818 is a drug developed by Vir Biotechnology for the following indication: In metastatic castration-resistant prostate cancer (mCRPC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VIR-5818
- Announced Date:
- January 8, 2025
- Indication:
- In metastatic castration-resistant prostate cancer (mCRPC).
Announcement
Vir Biotechnology, Inc today is presenting initial Phase 1 data from two of its dual-masked T-cell engagers (TCEs): VIR-5818, targeting a variety of HER2-expressing solid tumors; and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC).
AI Summary
Vir Biotechnology, Inc. is sharing promising Phase 1 clinical data for its dual-masked T-cell engagers: VIR-5818 and VIR-5500. VIR-5818 is being tested in patients with various HER2-expressing solid tumors. In those receiving doses of at least 400 µg/kg, 50% experienced tumor shrinkage, with 33% of HER2-positive colorectal cancer patients showing confirmed partial responses. These early results suggest that VIR-5818 has the potential to provide a targeted treatment option after multiple lines of prior therapy.
VIR-5500, aimed at treating metastatic castration-resistant prostate cancer by targeting PSMA, demonstrated PSA declines in all patients who received an initial dose of 120 µg/kg, with 58% achieving a PSA50 response. Both T-cell engagers exhibited encouraging safety profiles with no dose-limiting cytokine release syndrome reported and the maximum tolerated dose not yet reached, highlighting the potential benefits of the PRO-XTEN™ masking technology.
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XTEN - FDA Regulatory Timeline and Events
XTEN is a drug developed by Vir Biotechnology for the following indication: For oncology and infectious disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XTEN
- Announced Date:
- September 9, 2024
- Indication:
- For oncology and infectious disease
Announcement
Vir Biotechnology, Inc announced that the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
AI Summary
Vir Biotechnology recently announced that its exclusive worldwide license agreement with Sanofi has closed after the Hart-Scott-Rodino waiting period expired. This agreement gives Vir exclusive rights to use Sanofi’s PRO-XTENTM masking platform, an innovative technology that enhances drug discovery in oncology and infectious diseases.
The deal also provides Vir access to three clinical-stage masked T-cell engagers (TCEs) designed to treat various cancers. This strategic move is expected to strengthen Vir’s clinical pipeline and further its capabilities in developing advanced therapies. Additionally, key Sanofi experts in TCE development and the PRO-XTENTM platform will join Vir, supporting ongoing research and addressing unmet patient needs in cancer and infectious disease treatment.
Read Announcement
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