Vir Biotechnology's Hepatitis Delta Drug Combo Receives FDA Clearance and Fast Track Status

6/26/24 8:06:40 AM ET

Biotechnology: Biological Products (No Diagnostic Substances)

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Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company's Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.

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Recent Analyst Ratings for
$VIR

Date	Price Target	Rating	Analyst
1/29/2024	$23.00 → $9.00	Overweight → Neutral	JP Morgan
9/8/2023	$23.00 → $14.00	Buy → Neutral	BofA Securities
3/6/2023	$35.00 → $34.00	Neutral → Overweight	JP Morgan
2/21/2023	$41.00 → $53.00	Neutral → Buy	Goldman
1/27/2023	$18.00 → $30.00	Underweight → Equal-Weight	Morgan Stanley
9/14/2022	$40.00	Outperform	SVB Leerink
9/9/2022	$15.00	Underweight	Morgan Stanley
3/3/2022	$36.00 → $28.00	Underperform → Neutral	Baird

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Press Releases

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Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program
– Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 – – Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts – – Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares – – Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin in the first half of 2025 – – New data presented at AASLD The Liver Meeting. Investor conference call November 19, 2024, at 5.15 a.m. PT / 8.15 a.m. ET – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced positive results from the SO
11/18/24 9:15:00 PM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency
– Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical need – – Phase 2 SOLSTICE 24-week primary endpoint data for tobevibart and elebsiran in chronic hepatitis delta to be presented today at AASLD The Liver Meeting – – Positive opinion on E.U. orphan drug designation follows U.S. FDA fast track designation, highlighting growing recognition of the potential of tobevibart and elebsiran in chronic hepatitis delta – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on t
11/18/24 4:05:00 PM ET
$VIR
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Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting
– 39% of participants with low baseline Hepatitis B surface antigen (HBsAg) achieved HBsAg loss with tobevibart + elebsiran, and 46% with tobevibart + elebsiran + pegylated interferon alfa – – No new safety concerns were identified, and treatment-emergent adverse events were generally mild to moderate – – Late-breaking oral presentation of MARCH Part B study results at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® – – Key functional cure data from 24-week follow-up expected in Q2 2025 – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced end-of-treatment data from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart
11/15/24 11:00:00 AM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care

Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program
– Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 – – Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts – – Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares – – Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin in the first half of 2025 – – New data presented at AASLD The Liver Meeting. Investor conference call November 19, 2024, at 5.15 a.m. PT / 8.15 a.m. ET – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced positive results from the SO
11/18/24 9:15:00 PM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency
– Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical need – – Phase 2 SOLSTICE 24-week primary endpoint data for tobevibart and elebsiran in chronic hepatitis delta to be presented today at AASLD The Liver Meeting – – Positive opinion on E.U. orphan drug designation follows U.S. FDA fast track designation, highlighting growing recognition of the potential of tobevibart and elebsiran in chronic hepatitis delta – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on t
11/18/24 4:05:00 PM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting
– 39% of participants with low baseline Hepatitis B surface antigen (HBsAg) achieved HBsAg loss with tobevibart + elebsiran, and 46% with tobevibart + elebsiran + pegylated interferon alfa – – No new safety concerns were identified, and treatment-emergent adverse events were generally mild to moderate – – Late-breaking oral presentation of MARCH Part B study results at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® – – Key functional cure data from 24-week follow-up expected in Q2 2025 – Vir Biotechnology, Inc. (NASDAQ:VIR) today announced end-of-treatment data from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart
11/15/24 11:00:00 AM ET
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Vir Biotechnology's Hepatitis Delta Drug Combo Receives FDA Clearance and Fast Track Status
Vir Biotechnology, Inc. (NASDAQ:VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company's Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.
6/26/24 8:06:40 AM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Morgan Stanley Maintains Equal-Weight on Vir Biotechnology, Raises Price Target to $15
Morgan Stanley analyst Michelle Gilson maintains Vir Biotechnology (NASDAQ:VIR) with a Equal-Weight and raises the price target from $12 to $15.
6/6/24 9:12:28 AM ET
$VIR
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Why Is Infectious Disease-Focused Vir Biotechnology Stock Trading Higher On Wednesday?
On Wednesday, Vir Biotechnology Inc (NASDAQ:VIR) announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating tobevibart and elebsiran for chronic hepatitis delta. Preliminary data from the Phase 2 trial show that treatment with tobevibart alone or combined with elebsiran was generally well tolerated. Participants achieved high virologic response rates at weeks 12 and 24, durable virologic response through 48 weeks, and high alanine transaminase (ALT) normalization rates. High levels of alanine aminotransferase (ALT) within a range of 1000-2000 IU/mL, is the hallmark of this stage of HBV disease. Similar virologic suppression and ALT normaliz
6/5/24 2:51:30 PM ET
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$VIR
Leadership Updates

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Vir Biotechnology Appoints Jason O'Byrne as Chief Financial Officer
– Seasoned biotech executive brings decades of effective financial leadership to Vir – Vir Biotechnology Inc. (NASDAQ:VIR) today announced that Jason O'Byrne, MBA, is appointed as Executive Vice President and Chief Financial Officer (CFO), effective October 2, 2024. Mr. O'Byrne will join the Vir Executive Management Team and report directly to the company's Chief Executive Officer, Marianne De Backer, M.Sc., Ph.D., MBA. Mr. O'Byrne is an accomplished executive with more than 20 years of experience in finance and operations. He is a recognized champion of financial discipline and brings demonstrated financial leadership in capital allocation and formation, corporate strategy, and operation
9/10/24 8:05:00 AM ET
$VIR
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Lineage Announces Appointment of Charlotte Hubbert, Ph.D., as Vice President of Corporate Development
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the appointment of veteran industry executive Charlotte Hubbert, Ph.D., as Vice President of Corporate Development. Dr. Hubbert has an extensive background in cell therapy research and venture investment across a broad range of therapeutic modalities and development stages, and has a proven ability to combine deep scientific expertise and business development acumen to identify innovative opportunities to drive both returns and impact. Dr. Hubbert previously served as Partner and Head of Gates Foundation Venture
4/1/24 8:00:00 AM ET
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$VIR
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Biotechnology: Pharmaceutical Preparations
Vir Biotechnology Appoints Jennifer Towne, Ph.D., as Executive Vice President and Chief Scientific Officer
Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the appointment of Jennifer Towne, Ph.D., as Executive Vice President and Chief Scientific Officer, effective November 6, 2023. Dr. Towne will be responsible for leading the Company's research function from basic research through scale-up manufacturing and the introduction of drug candidates to clinical trials. She will report to Vir's Chief Executive Officer Marianne De Backer, M.Sc., Ph.D., MBA, and will join the Company's Executive Management Team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231026830042/en/Jennifer Towne, Ph.D., appointed as Executive Vice President and
10/30/23 8:00:00 AM ET
$VIR
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Health Care

Vir Biotechnology's Hepatitis Delta Drug Combo Receives FDA Clearance and Fast Track Status

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Recent Analyst Ratings for $VIR

$VIR Press Releases

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Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program

Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency

Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting

$VIR SEC Filings

SEC Form 10-Q filed by Vir Biotechnology Inc.

Vir Biotechnology Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

Vir Biotechnology Inc. filed SEC Form 8-K: Completion of Acquisition or Disposition of Assets, Leadership Update, Regulation FD Disclosure, Financial Statements and Exhibits

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Vir Biotechnology downgraded by JP Morgan with a new price target

Vir Biotechnology downgraded by BofA Securities with a new price target

Vir Biotechnology upgraded by JP Morgan with a new price target

Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program

Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency

Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting

EVP & Chief Financial Officer O'Byrne Jason was granted 75,000 units of Common Stock (SEC Form 4)

EVP and General Counsel De Verneuil Vanina sold $44,454 worth of Common Stock (4,397 units at $10.11), decreasing direct ownership by 7% to 56,973 units (SEC Form 4)

EVP and General Counsel De Verneuil Vanina sold $32,332 worth of Common Stock (3,750 units at $8.62), decreasing direct ownership by 6% to 61,370 units (SEC Form 4)

Amendment: SEC Form SC 13G/A filed by Vir Biotechnology Inc.

SEC Form SC 13G/A filed by Vir Biotechnology Inc. (Amendment)

SEC Form SC 13G/A filed by Vir Biotechnology Inc. (Amendment)

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