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Vir Biotechnology Inc (VIR)
Vir Biotechnology Inc (VIR) ニュース

Vir Biotechnology Inc (VIR)

7.465

0.065

(0.88%)

終了 12月28日 6:00AM

7.53

0.065

(0.87%)

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プレミアム

Vir Biotechnology to Present at the 43rd Annual J.P. Morgan Healthcare Conference

Vir Biotechnology Inc. (NASDAQ: VIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will present at the...

Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta

– Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs – – Phase 3...

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

Vir Biotechnology to Host Virtual Investor Event on PRO-XTEN™ Masked T-Cell Engager Programs

Vir Biotechnology, Inc. (NASDAQ:VIR) today announced it will host a virtual investor event to discuss initial data from the dual-masked Phase 1...

Vir Biotechnology to Participate in the 7th Annual Evercore ISI HealthCONx Conference

Vir Biotechnology Inc. (NASDAQ: VIR) today announced that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, is scheduled to...

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...

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...

Form 4 - Statement of changes in beneficial ownership of securities

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...

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Monksdream

Monksdream 5日前

DewDiligence

DewDiligence 2月前

VIR reports 3Q24 results—9/30/24 cash=$1.19B:

https://www.businesswire.com/news/home/20241031806056/en

Monksdream

Monksdream 2月前

TheFinalCD

TheFinalCD 5月前

https://x.com/NuntioBot/status/1819101232079786025

https://finviz.com/quote.ashx?t=VIR&p=d#google_vignette

Message in reply to:
VIR pares pipeline—reduces workforce 25%:

https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Reports-Second-Quarter-2024-Financial-Results-and-Announces-Strategic-Restructuring-to-Prioritize-Clinical-Stage-Pipeline-Opportunities/default.aspx

VIR has terminated its programs in flu, COVID, and T cell-based viral vectors.

VIR also announced a collaboration with SNY to develop T-cell engagers (https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Acts-on-Expanded-Strategy-of-Powering-the-Immune-System-Through-Exclusive-Worldwide-License-Agreement-with-Sanofi-for-Multiple-Potential-Best-in-Class-Clinical-Stage-T-cell-Engagers/default.aspx ), but financial terms of the collaboration were not disclosed.

2Q24 CC slides:
https://s203.q4cdn.com/628578897/files/doc_presentations/2024/Jul/Vir-Corporate-Presentation_Q2-2024.pdf

DewDiligence

DewDiligence 5月前

VIR pares pipeline—reduces workforce 25%:

https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Reports-Second-Quarter-2024-Financial-Results-and-Announces-Strategic-Restructuring-to-Prioritize-Clinical-Stage-Pipeline-Opportunities/default.aspx

VIR has terminated its programs in flu, COVID, and T cell-based viral vectors.

VIR also announced a collaboration with SNY to develop T-cell engagers (https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Acts-on-Expanded-Strategy-of-Powering-the-Immune-System-Through-Exclusive-Worldwide-License-Agreement-with-Sanofi-for-Multiple-Potential-Best-in-Class-Clinical-Stage-T-cell-Engagers/default.aspx ), but financial terms of the collaboration were not disclosed.

2Q24 CC slides:
https://s203.q4cdn.com/628578897/files/doc_presentations/2024/Jul/Vir-Corporate-Presentation_Q2-2024.pdf

Monksdream

Monksdream 5月前

Monksdream

Monksdream 6月前

DewDiligence

DewDiligence 7月前

VIR +18% on phase-2 HDV data at EASL:

https://finance.yahoo.com/news/tobevibart-monotherapy-combination-therapy-elebsiran-093000369.html

Note: HDV is a subset of HBV insofar as HDV resides within HBV’s capsid.

DewDiligence

DewDiligence 8月前

VIR 1Q24 CC transcript:

https://finance.yahoo.com/news/vir-biotechnology-inc-nasdaq-vir-170535096.html

Monksdream

Monksdream 8月前

VIR still reversing off the recent 52 week low

DewDiligence

DewDiligence 8月前

VIR reports 1Q24 results—3/31/24 cash=$1.51B(!):

https://www.businesswire.com/news/home/20240502260564/en

VIR re-iterated guidance for 2024 operating expenses of $650-680M.

CC slides:
https://investors.vir.bio/files/doc_financials/2024/q1/Vir-Corporate-Presentation_Q1-2024.pdf

Monksdream

Monksdream 8月前

DewDiligence

DewDiligence 8月前

VIR adds two luminaries to BoD:

https://www.businesswire.com/news/home/20240418098064/en

The capsule bios in the PR speak for themselves.

DewDiligence

DewDiligence 10月前

VIR 4Q23 CC transcript:

https://finance.yahoo.com/news/q4-2023-vir-biotechnology-inc-185403667.html

DewDiligence

DewDiligence 10月前

VIR 4Q23 CC slides:

https://investors.vir.bio/files/doc_presentations/2024/02/22/Vir-Corporate-Presentation_Q4-2023.pdf

DewDiligence

DewDiligence 10月前

VIR reports 4Q23 results—issues 2024 expense guidance:

https://www.businesswire.com/news/home/20240222740501/en

12/31/23 cash was $1.63B, after burning $108M during 4Q23.

2024 guidance for SG&A + R&D GAAP expenses is $650-680M.

At the current share price, VIR has an enterprise value of roughly negative $200M.

DewDiligence

DewDiligence 10月前

VIR’s CMO left the company, which explains the exercise-and-hold transaction from January in the post I'm replying to:

https://finance.yahoo.com/news/vir-biotechnology-announces-dr-phil-213000676.html

Note: The above was issued on 2/20/24.

DewDiligence

DewDiligence 10月前

GSK, VIR terminate flu collaboration inked in 2021:

https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001706431/000162828024006346/vir-20240221.htm

This outcome is not surprising outcome insofar as the phase-2 trial of VIR-2484, the lead compound of the collaboration, was a failure ( #msg-172395320).

DewDiligence

DewDiligence 12月前

VIR’s CMO exercised and held ~$800K of stock yesterday:

https://www.sec.gov/Archives/edgar/data/1706431/000162828024000169/xslF345X05/wk-form4_1704311270.xml

The options in question did not expire until 2027-2028.

DewDiligence

DewDiligence 1年前

VIR cuts workforce 12%:

https://www.businesswire.com/news/home/20231213396441/en

It’s bizarre to see belt-tightening by a company with $1.7B of net cash (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001706431/000162828023036702/vir-20230930.htm#i4ba948c416a6412b946073491455ca74_19 ), but it’s probably the right thing to do inasmuch as the stock’s EV is deeply negative.

harry crumb

harry crumb 1年前

Nice move today

DewDiligence

DewDiligence 1年前

VIR -45% on phase-2 failure in influenza:

https://finance.yahoo.com/news/vir-biotechnology-announces-topline-data-120000102.html Vir Biotechnology…today announced that the Phase 2 PENINSULA trial evaluating VIR-2482 for the prevention of symptomatic influenza A illness did not meet primary or secondary efficacy endpoints. Why such a steep selloff? One reason is that VIR has tended to present itself to investors as all-powerful and all-knowing, which is perhaps a consequence of having George Scangos as (ex)CEO and having raised a huge amount of capital based on management’s reputation.

DewDiligence

DewDiligence 2年前

VIR starts 4-drug phase-2 HBV trial:

https://www.globenewswire.com/news-release/2023/05/11/2666740/0/en/Vir-Biotechnology-Announces-First-Patient-Dosed-in-New-Phase-2-Chronic-Hepatitis-B-Virus-Trial-Evaluating-Combinations-of-VIR-2218-VIR-3434-PEG-IFN%CE%B1-and-an-NRTI.html

The four drugs are: VIR-2218, a siRNA; VIR-3434, a mAb; PEG-IFN; and a (generic) nucleoside.

A separate phase-2 trial (VIR calls it a “subprotocol”) will test VIR-3434 and a nuke, with and without VIR-2218, in patients who are chronic inactive carriers of the HBV virus. I'm unclear as to whether this second trial is for research purposes or for an addressable commercial market.

DewDiligence

DewDiligence 2年前

48w VIR-2219 +peg-IFN—>31% HBs seroconverion:

https://www.globenewswire.com/news-release/2022/11/06/2549180/0/en/Vir-Biotechnology-Presents-New-Data-Evaluating-the-Potential-for-VIR-2218-and-VIR-3434-to-Achieve-a-Functional-Cure-for-Chronic-Hepatitis-B-Virus-HBV-Infection.html

The 31% figure is impressive insofar as peg-IFN by itself has a 48w seroconversion rate of only 5-10%. Of course, a 48w regimen of VIR-2219 + peg-IFN won’t be any easier to tolerate than 48w of peg-IFN monotherapy, so this regimen is still far from the ultimate answer for treating chronic HBV.

VIR has started testing the triple combination of VIR-2219 (siRNA) + VIR-3434 (mAb) + peg-IFN; initial data are expected in 2H23.

DewDiligence

DewDiligence 3年前

VIR EASL presentations:

https://www.globenewswire.com/news-release/2022/06/25/2469082/0/en/Vir-Biotechnology-Announces-New-Clinical-Data-From-its-Broad-Hepatitis-B-Program.html

No CC.

DewDiligence

DewDiligence 3年前

VIR HBV webcast slides:

https://investors.vir.bio/static-files/7ece44c3-0585-47af-81b4-2199889d6934

DewDiligence

DewDiligence 3年前

VIR -14% on amended Sotrovimab EUA due to Omicron BA.2 variant:

https://finance.yahoo.com/news/us-food-drug-administration-revises-200400156.html GlaxoSmithKline plc and Vir Biotechnology…today announced that the US Food and Drug Administration has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab, an investigational monoclonal antibody. The FDA has determined that, based on the totality of available evidence, including new live virus data generated by Vir, it is unlikely that the sotrovimab 500 mg dose will be effective against the Omicron BA.2 variant.

GSK and Vir are preparing a package of data in support of a higher dose of sotrovimab for the Omicron BA.2 subvariant and will be sharing these data with regulatory and health authorities around the world for discussion. This PR was issued after the close, but the market apparently got wind of the FDA decision about 3:45pm ET.

DewDiligence

DewDiligence 3年前

VIR 4Q21 results:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html As of December 31, 2021, excluding restricted cash, the Company had approximately $909.5 million in cash, cash equivalents, and investments. Excluding restricted cash and its equity investment in Brii Biosciences, the Company had approximately $766.4 million in cash, cash equivalents and investments.

DewDiligence

DewDiligence 3年前

VIR’s 2022 HBV newsflow:

https://www.globenewswire.com/news-release/2022/02/24/2391890/0/en/Vir-Biotechnology-Provides-Corporate-Update-and-Reports-Fourth-Quarter-and-Full-Year-2021-Financial-Results.html In 2022, the Company expects data readouts from multiple trials evaluating VIR-2218 and VIR-3434:

• Initial data from the first cohorts of Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial of VIR-2218 in combination with VIR-3434, are expected in the first half of 2022.

• Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-alpha are expected in the first half of 2022.

• Additional data from the Phase 1 monotherapy trial of VIR-3434 are expected in the first half of 2022.

• The Company’s collaborator, Brii Biosciences, continues to lead the Phase 2 trial evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection. Initial data are expected in the second half of 2022. Evidently, there will not be a 2022 readout from the phase-2 trial testing combinations of VIR-2218, GILD’s GS-9688, Vemlidy (TAF), and Opdivo (#msg-167061759, #msg-160854272, #msg-167063133).

rwwest

Up so far on another Biotech down day
Seems like a good omen.

DewDiligence

DewDiligence 3年前

VIR slide set from JPM:

https://investors.vir.bio/static-files/7ecf45fb-6918-4cf8-9a02-b8c12183ca4f

DewDiligence

DewDiligence 3年前

VIR/GILD start phase-2 trial testing quadruple regimen of VIR-2218; GS-9688; Opdivo; and Vemlidy (TAF) in (both nuc-suppressed and viremic) HBV patients:

https://finance.yahoo.com/news/vir-biotechnology-announces-initiation-phase-133000267.html

I’m not sure why it took almost a year for this trial to begin enrolling patients—the PR announcing the collaboration was issued on 1/12/21.

Please see #msg-160854272 for background.

HokieHead

HokieHead 3年前

Loaded again. After omicron news all weekend this will be the next MRNA biotech. $75+ by years end for starters imo.

HokieHead

HokieHead 3年前

In $46, omicron play.

DewDiligence

DewDiligence 3年前

VIR starts HBV_combination_trial_of_ VIR-2218 and VIR-3434:

https://finance.yahoo.com/news/vir-biotechnology-initiates-phase-2-123000780.html The multi-center, open-label Phase 2 trial is designed to evaluate the safety, tolerability and efficacy of the combination of VIR-2218 and VIR-3434 in approximately 90 adult patients (ages 18 to 65) with chronic HBV infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Both VIR-2218 and VIR-3434 will be administered via subcutaneous injection at varying dose levels over the course of the trial for a treatment period ranging from four to 20 weeks, and a follow-up period of up to 116 weeks, depending on the dosing cohort.

…VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S and core), which may be acting as immune tolerogens. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, as well as reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 “vaccinal mutation,” allowing it to potentially function as a therapeutic T cell vaccine against HBV. See #msg-164593550, #msg-161217289, and #msg-164599741 for related info.

DewDiligence

DewDiligence 4年前

VIR -6% on VIR-2218 and VIR-3434 monotherapy data presented at EASL:

https://finance.yahoo.com/news/vir-biotechnology-presents-clinical-data-125000851.html

CC to discuss these data with investment community at 11am ET.

level42

level42 4年前

"profound efficacy." Vir Biotechnology and GSK plan to seek emergency use authorization for their experimental COVID-19 antibody therapy after interim data from a study showed 85% reduction in hospitalization and deaths among patients.

Based on these positive results, Vir and GlaxoSmithKline intend to request Emergency Use Authorization (EUA) for VIR-7831 from the U.S. Food and Drug Administration (FDA) and other international regulators.

"We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients," GlaxoSmithKline chief scientific officer Dr. Hal Barron said. "We look forward to the possibility of making VIR-7831 available to patients as soon as possible."

interloper

interloper 4年前

Too high too fast. Very typical price movement. I you think your gonna ride a rocket to the moon you better be ready when the booster fuel runs out.

dealerschool2006

dealerschool2006 4年前

why is VIR coming back down???

rtrstock

rtrstock 4年前

Huge disappointment.

This could go back to under 20.00 pps

Should have sold at 140.00

This stock price is just based on hype, the collapse is the reality of things.

CatBirdSeat

CatBirdSeat 4年前

Two New Rockships Taking Off After VIR

Behold! FNMA & FMCC

Ka Ching ! Baby! $$$$

rtrstock

rtrstock 4年前

I Should have sold at 140.00

Now it's in a death spiral.

Robinhood shows this listing at a completely different price than ihub.

Srhogan1984

Srhogan1984 4年前

Full of crap haha

ClayTrader

ClayTrader 4年前

* * $VIR Video Chart 01-26-2021 * *

Link to Video - click here to watch the technical chart video

Srhogan1984

Srhogan1984 4年前

Sounds like a short to me. You need a bog squeeze? Haha

DewDiligence

DewDiligence 4年前

Today's move is somewhat scary in the context of #msg-160142077.

DewDiligence

DewDiligence 4年前

VIR—(+40% undeservedly, IMO)—on_interim_phase-1_data_for VIR-3434_in_HBV:

https://www.globenewswire.com/news-release/2021/01/26/2164220/0/en/Initial-Data-from-Ongoing-Phase-1-Trial-of-VIR-3434-for-Chronic-Hepatitis-B-Virus-Infection-Demonstrates-Significant-and-Rapid-Reduction-in-Hepatitis-B-Surface-Antigen.html

The mean reduction in HBsAg (n=6) was 1.3 logs after 8 days. That’s not bad, but neither is it a knock-your-socks-off result. Monotherapy is unlikely to generate a functional cure in HBV, no matter how potent the agent may be against HBsAg.

VIR-3434 is a monoclonal antibody and is VIR’s second HBV agent in the clinic; the first is VIR-2218, an RNAi agent (#msg-155042587).

DewDiligence

DewDiligence 4年前

Not really. It's just a phase-2 trial, not a full-fledged partnership.

DewDiligence

DewDiligence 4年前

GILD, VIR collaborate on phase-2 HBV trial:

https://www.businesswire.com/news/home/20210112005578/en The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.

Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial. I.e., no cash is changing hands between the two companies.

Srhogan1984

Srhogan1984 4年前

Vir Biotechnology

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