Vir Biotechnology, Inc.

Legendary investor Warren Buffett advises to be fearful when others are greedy, and be greedy when others are fearful. One way we can try to measure the level of fear in a given stock is through a technical analysis indicator called the Relative Strength Index, or RSI, which measures momentum on a scale of zero to 100. A stock is considered to be oversold if the RSI reading falls below 30.
In trading on Thursday, shares of Vir Biotechnology Inc (Symbol: VIR) entered into oversold territory, hitting an RSI reading of 27.1, after changing hands as low as $8.07 per share. By comparison, the current RSI reading of the S&P 500 ETF (SPY) is 40.2. A bullish investor could look at VIR's 27.1 RSI reading today as a sign that the recent heavy selling is in the process of exhausting itself, and begin to look for entry point opportunities on the buy side. The chart below shows the one year performance of VIR shares:
Looking at the chart above, VIR's low point in its 52 week range is $6.56 per share, with $14.45 as the 52 week high point — that compares with a last trade of $8.11.
Find out what 9 other oversold stocks you need to know about »
Also see:
FFIV Price Target
BSJO shares outstanding history
KDN Historical Stock Prices
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Vir Biotechnology Becomes Oversold (VIR)

GSK plc GSK reported fourth-quarter 2024 core earnings of 59 cents per American depositary share (ADS), which beat the Zacks Consensus Estimate of 53 cents. Core earnings declined 20% year over year on a reported basis and 10% at a constant exchange rate (CER) due to increased operating expenses during the quarter.
See the Zacks Earnings Calendar to stay ahead of market-making news.
Quarterly revenues rose 1% on a reported basis and 4% at CER to $10.4 billion (£8.12 billion). The top line outpaced the Zacks Consensus Estimate of $10.00 billion. The upside can be attributed to rising sales of its HIV and oncology products, partially offset by the declining vaccine sales.
All growth rates mentioned below are on a year-over-year basis and at CER.
GSK’s Segmental Discussion
GSK reports under three segments — General Medicines, Specialty Medicines and Vaccines. Sales in the Specialty Medicines and General Medicines segments rose 17% and 6%, respectively. Vaccine sales declined 12%.
GSK’s Specialty Medicines Drive Top Line
HIV sales rose 14% during the quarter, driven by strong patient demand for the company’s two-drug regimens — Dovato and J&J JNJ-partnered Juluca — and long-acting medications, Apretude and Cabenuva. The combined revenues from these four drugs contributed more than 60% to the total HIV sales during the quarter.
Sales of Dovato rose 27%, while those of the J&J-partnered Juluca increased 10%. Since their commercial launch, both these medications have been eroding the sales and market share of the company’s three-drug regimens — Triumeq and Tivicay. While Triumeq sales declined 11%, sales of Tivicay rose 1% during the quarter.
Sales of Apretude and Cabenuva rose 65% and 43%, respectively.
Sales of the respiratory drug Nucala were up 7% during the quarter, driven by strong performance in ex-U.S. territories.
Sales of the immuno-inflammation drug Benlysta were up 12% in the quarter, reflecting strong product demand across all regions.
Oncology sales rose 72%, driven by strong patient demand for Jemperli and Ojjaara. Jemperli added £149 million to GSK’s top line compared with £130 million in third-quarter 2024, driven by new patient starts across all regions.
New blood cancer drug Ojjaara/Omjjara generated £118 million in product sales compared with £98 million in third-quarter 2024. While the drug was approved by the FDA in September 2023, it received approval in the EU in January 2024.
Zejula sales fell 3% in the quarter. Though the drug’s U.S. sales were adversely impacted due to favorable price impacts in the year-ago period, continued growth in ex-U.S. territories partially offset the same.
GSK added £11 million from the sales of its Vir Biotechnology VIR-partnered Xevudy during the quarter.
Sales Performance of GSK’s General Medicines
In this segment, the upside was primarily driven by solid sales growth of asthma inhaler Trelegy Ellipta across all regions. This was partially offset by the removal of the Average Manufacturer Price cap on Medicaid drug prices in the United States, adversely impacting sales of some established drugs.
Sales of Trelegy Ellipta and Flixotide/Flovent surged 17% and 47%, respectively. Sales of Advair/Seretide and Anoro Ellipta fell 2% each. Revlar/Breo Ellipta sales declined 5%.
GSK’s Vaccine Sales Decline
The decline in vaccine sales was primarily due to lower sales of its RSV vaccine Arexvy. The figure dropped 69% during the quarter. This downtick can be attributed to the restrictive recommendation issued by the U.S. Centers for Disease Control and Prevention last year for individuals in the 60-74 age bracket.
Sales of the company’s shingles vaccine, Shingrix, fell 4% during the quarter due to lower demand in the U.S. and International markets. This was partially offset by rising sales in Europe.
In Meningitis vaccines, sales of Bexsero rose 39%, while Menveo sales declined 41%. Sales of the influenza vaccine, Fluarix, rose 14%. Sales of Established vaccines improved 8%.
During the quarter, GSK did not record any sales from the COVID-19 booster vaccine, which was co-developed with Sanofi SNY.
Operating Expenses
Core selling, general and administration (SG&A) costs rose 6% to £2.70 billion. This was due to continued investments by management to support theglobal marketexpansion of its marketed drugs.
Core research and development expenses rose 4% to £1.82 billion, by management's continued investment in pipeline advancement.
GSK’s Encouraging 2025 Guidance
GSK issued fresh guidance for 2025. It expects sales to increase 3-5% during the year.
Management expects sales of specialty medicines to increase by a low double-digit percentage at CER in 2025, while sales in the General Medicines segment are expected to be broadly stable at CER. However, management expects vaccine sales to witness a low-single-digit decline. GSK does not expect any further COVID-19-related sales in 2025.
GSK expects both core operating profit and core EPS to grow in the range of 6-8%.
Our Take on GSK’s Results
GSK’s fourth-quarter results were impressive, with both earnings and sales beating estimates. This was driven by sales growth in the Specialty Medicines segment. The company’s oncology portfolio, which had been facing a steep decline due to lower Blenrep sales in recent quarters, registered impressive growth on the back of rising Jemperli sales and the newly launched Ojjaara.
The encouraging results were further fueled by GSK’s strong optimism around its drug pipeline and future commercial launches, based on which management hiked its sales outlook for 2031. It now expects to generate sales of more than £40 billion, an increase from its previous projection of more than £38 billion.
Management’s attempts to enhance shareholder returns also seem encouraging. Apart from the quarterly results, GSK also announced plans for a share buyback program worth £2 billion, which will be implemented over the next 18 months.
Shares of GSK rose nearly 6% in pre-market trading today, likely due to the encouraging long-term outlook and the buyback program. In the past year, the stock has lost 16% compared with the industry’s 10% decline.
Image Source: Zacks Investment Research
This increase in long-term outlook is mainly driven by the company’s prioritized focus on HIV, immunology/respiratory and oncology therapeutic areas. It has 71 assets in clinical development, which include 19 candidates that are either in late-stage development or under regulatory review.
This year, GSK expects to launch five new products/line extensions, including Blenrep (relaunch in multiple myeloma), depemokimab (for severe asthma and chronic rhinosinusitis with nasal polyps) and Nucala (for COPD). The FDA is currently reviewing regulatory filings for gepotidacin (for uncomplicated urinary tract infection) and a pentavalent MenABCWY meningococcal vaccine, with final decisions expected in the first quarter of 2025.
GSK PLC Sponsored ADR Price
GSK’s Zacks Rank
GSK currently has a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Sanofi (SNY) : Free Stock Analysis Report
GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Vir Biotechnology, Inc. (VIR) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

GSK Beats on Q4 Earnings & Sales, Stock Up on Raised Long-Term Outlook

Among the underlying components of the Russell 3000 index, we saw noteworthy options trading volume today in Mastercard Inc (Symbol: MA), where a total of 34,458 contracts have traded so far, representing approximately 3.4 million underlying shares. That amounts to about 136.1% of MA's average daily trading volume over the past month of 2.5 million shares. Especially high volume was seen for the $380 strike call option expiring January 17, 2025, with 10,066 contracts trading so far today, representing approximately 1.0 million underlying shares of MA. Below is a chart showing MA's trailing twelve month trading history, with the $380 strike highlighted in orange:
C3.ai Inc (Symbol: AI) options are showing a volume of 147,226 contracts thus far today. That number of contracts represents approximately 14.7 million underlying shares, working out to a sizeable 129% of AI's average daily trading volume over the past month, of 11.4 million shares. Especially high volume was seen for the $41 strike call option expiring January 10, 2025, with 31,118 contracts trading so far today, representing approximately 3.1 million underlying shares of AI. Below is a chart showing AI's trailing twelve month trading history, with the $41 strike highlighted in orange:
And Vir Biotechnology Inc (Symbol: VIR) saw options trading volume of 14,213 contracts, representing approximately 1.4 million underlying shares or approximately 126.7% of VIR's average daily trading volume over the past month, of 1.1 million shares. Especially high volume was seen for the $15 strike call option expiring January 17, 2025, with 4,099 contracts trading so far today, representing approximately 409,900 underlying shares of VIR. Below is a chart showing VIR's trailing twelve month trading history, with the $15 strike highlighted in orange:
For the various different available expirations for MA options, AI options, or VIR options, visit StockOptionsChannel.com.
Also see:
Consumer Stocks Hedge Funds Are Selling
Top Ten Hedge Funds Holding ECX
DAN Historical Stock Prices
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Noteworthy Wednesday Option Activity: MA, AI, VIR

In trading on Tuesday, shares of Vir Biotechnology Inc (Symbol: VIR) crossed above their 200 day moving average of $9.11, changing hands as high as $10.00 per share. Vir Biotechnology Inc shares are currently trading up about 15.2% on the day. The chart below shows the one year performance of VIR shares, versus its 200 day moving average:
Looking at the chart above, VIR's low point in its 52 week range is $6.56 per share, with $13.09 as the 52 week high point — that compares with a last trade of $9.33.
Free Report: Top 8%+ Dividends (paid monthly)
Click here to find out which 9 other stocks recently crossed above their 200 day moving average »
Also see:
Institutional Holders of SHSP
CHWY market cap history
GPAC YTD Return
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

VIR Makes Bullish Cross Above Critical Moving Average

(RTTNews) - There seems to be no respite from job cuts as several companies announced workforce reductions this week as well. Meanwhile, on the research front, there was a mix of news: encouraging results emerged related to Alzheimer's drug Leqembi and antidiabetic medication Tirzepatide, while a prostate cancer drug trial unfortunately disappointed. In a significant development, the week also saw the approval of the first engineered cell therapy for a solid tumor.
Let's delve into the news in detail.
Layoffs
FibroGen Inc. (FGEN) on Tuesday announced that it is reducing its headcount in the U.S. by approximately 75% as it prepares to shutter its once-promising Pamrevlumab development program. On July 30, 2024, the company's stock went into a freefall, plummeting nearly 48%, on news of its two late-stage trials of Pamrevlumab in patients with pancreatic cancer failing to meet the primary endpoint.
FGEN closed Friday's trading at $0.42, down 8.94%.
HilleVax Inc. (HLVX), a clinical-stage biopharmaceutical company developing novel vaccines, on Wednesday announced that it is reducing its workforce by approximately 41 employees, or roughly 40%, to rein in operating expenses. The lead drug candidate is HIL-214, a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. HIL-214 demonstrated statistically significant efficacy against moderate or severe AGE due to norovirus in a Phase 2b study in adults, dubbed NOR-211. However, in a phase IIb trial of HIL-214 in infants of approximately 5 months of age, dubbed NEST-IN1, the primary or secondary efficacy endpoints were not met. The company has decided to discontinue HIL-214's development for infants but will explore its potential application for adults.
HLVX closed Friday's trading at $1.70, down 3.95%.
Vir Biotechnology Inc. (VIR) on Thursday announced that it has initiated a strategic restructuring to focus on the highest value near-term opportunities. As part of the organizational realignment and optimization, the company has decided to phase out programs in influenza, COVID-19, and its T cell-based viral vector platform. This will also lead to a workforce reduction of approximately 25% or approximately 140 employees.
VIR closed Friday's trading at $9.21, down 5.34%.
uniQure N.V. (QURE), a gene therapy company, which recently sold its global manufacturing facility in Lexington, Massachusetts to Contract Development and Manufacturing Organization Genezen, on Thursday announced major organizational changes. In an effort to conserve capital, streamline operations, and ensure sufficient cash resources to achieve multiple potentially meaningful value creating milestones, the company has decided to eliminate approximately 65% or 300 roles across the organization, inclusive of the sale of Lexington manufacturing facility. The restructuring is expected to be completed in the fourth quarter of 2024.
QURE closed Friday's trading at $7.31, down 2.27%.
Arbutus Biopharma Corp. (ABUS) is another company that is downsizing its workforce to streamline operations. The company on Thursday announced that it is ceasing all HBV discovery efforts and discontinuing its IM-PROVE III clinical trial, a phase IIa clinical trial evaluating lead drug candidate Imdusiran and nucleos(t)ide analogue (NA) therapy in combination with intermittent low doses of approved immune checkpoint inhibitor Durvalumab in patients with chronic HBV. This would result in a reduction in workforce by 40% and extension of expected cash runway into the fourth quarter of 2026. The company will now focus on phase 2b development of Imdusiran and another drug candidate AB-101, which is under a phase Ia/Ib trial for chronic HBV.
ABUS closed Friday's trading at $3.73, down 1.97%.
Pfizer Inc. (PFE), which recently pulled the plug on its investigational gene therapy Fordadistrogene movaparvovec for Duchenne muscular dystrophy, has decided to lay off 150 employees at its Sanford facility in Lee County. The company will also lay off 60 employees in its sterile injectable facility located in Rocky Mount in Nash County, according to reports. The company is targeting at least $4 billion in net cost savings by end of this year from a previously announced cost realignment program. A new cost reduction program announced by Pfizer in May of this year is expected to deliver savings of approximately $1.5 billion by the end of 2027.
FDA Spotlight
Vertex Pharmaceuticals Inc. (VRTX) on Tuesday announced that its New Drug Application for Suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor, has been accepted for priority review by the FDA. Suzetrigine is proposed for the treatment of moderate-to-severe acute pain. The FDA decision is due on January 30, 2025. If approved, Suzetrigine could become the first new class of medication for treating acute pain in more than two decades.
VRTX closed Friday's trading at $494.46, down 2.24%.
Adaptimmune Therapeutics plc (ADAP) on Thursday announced that Tecelra has been granted accelerated approval by the FDA for the treatment of advanced MAGE-A4+synovial sarcoma in adults with certain human leukocyte antigen (HLA) types who have received prior chemotherapy. Tecelra becomes the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.
ADAP closed Friday's trading at $1.17, down 7.87%.
Zevra Therapeutics Inc. (ZVRA) on Friday announced that an FDA panel has voted 11-5 recommending approval of its lead drug candidate Arimoclomol for the treatment of patients with Niemann-Pick disease type C (NPC). The FDA's final decision is due on September 21, 2024. Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder, marked by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various tissues and organs, including the brain.
ZVRA closed Friday's trading at $6.30.
Deal or No Deal
23andMe Holding Co. (ME) on Friday turned down the take-private proposal of Anne Wojcicki, Chief Executive Officer, Co-Founder, and Chair of the Board of Directors of the company. Anne offered to acquire all of the outstanding shares of 23andMe not owned by her or her affiliates or any other stockholder that she invites to roll over their shares for cash consideration of $0.40 per share of Class A Common Stock or Class B Common Stock. The Special Committee of the Board of Directors of the company, which reviewed the CEO's proposal, said it is "disappointed with the proposal for multiple reasons, including because it provides no premium to the closing price per share on Wednesday, July 31st, it lacks committed financing, and it is conditional in nature."
ME closed Friday's trading at $0.38, down 0.26%.
Breakthroughs and Setbacks
Eisai Co. Ltd/Biogen Inc.'s (BIIB) Alzheimer's drug Leqembi showed improved cognition and function in patients with early Alzheimer's disease who received continuous treatment with the drug for over three years, revels a global phase III study, dubbed Clarity AD. Moreover, no additional safety concerns were observed with the extended Leqembi treatment over a three-year period. Leqembi was granted traditional FDA approval in July 2023 for use as an intravenous (IV) infusion in patients with mild cognitive impairment due to Alzheimer's disease and mild AD dementia. The company is also developing a subcutaneous injection formulation of Leqembi to enhance convenience for patients. It should be noted that last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Leqembi for Alzheimer's disease. The committee concluded that the drug's benefits do not outweigh the risks of serious side effects, such as brain swelling and potential bleeding, observed in patients who received the treatment.
BIIB closed Friday's trading at $205.66, down 2.39%.
Eli Lilly and Co.'s (LLY) antidiabetic medication Tirzepatide has shown to reduce the risk of heart failure outcomes - heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death - by 38% compared to placebo in a phase III trial in adults with heart failure with preserved ejection fraction (HFpEF) and obesity, with or without type 2 diabetes. In the trial, dubbed SUMMIT, the drug also significantly improved heart failure symptoms and physical limitations and led to 15.7% weight loss in a combined population of people with and without type 2 diabetes. Tirzepatide was approved by the FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control on May 13, 2022, and as Zepbound for adults with obesity or those who are overweight who also have a weight-related comorbid condition on November 8, 2023. Both Mounjaro and Zepbound are approved as an adjunct to diet and exercise.
LLY closed Friday's trading at $804.46, down 3.36%.
Agios Pharmaceuticals Inc.'s (AGIO) blood disorder drug Pyrukynd has failed to meet the primary endpoint of transfusion reduction response in a phase III study in children aged 1 to less than 18 years with pyruvate kinase (PK) deficiency who are regularly transfused, dubbed ACTIVATE-KidsT. Although the primary endpoint was not met, the results were clinically meaningful, according to the company. A phase III trial of Pyrukynd in children with PK deficiency who are not regularly transfused, dubbed ACTIVATE-kids, is ongoing, with topline data anticipated in 2025. Pyrukynd is approved for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency in the U.S., EU and Great Britain.
AGIO closed Friday's trading at $43.96, down 1.21%.
Shares of MacroGenics Inc. (MGNX) have been on a downward spiral since the company provided an update on its TAMARACK trial in May of this year. TAMARACK is a phase II study evaluating the company's investigational drug Vobra duo in metastatic castration-resistant prostate cancer. On May 9, 2024, the company revealed that a total of five patient deaths occurred in the TAMARACK study. After a review of accumulated study data, MacroGenics in late July, agreed with the study's Independent Data Monitoring Committee's (IDMC) recommendation that study treatment should be discontinued for the remaining metastatic castration-resistant prostate cancer study participants who potentially could have received additional doses.
MGNX closed Friday's trading at $3.83, down 4.25%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Weekly Biotech Buzz: FGEN Cuts Jobs, FDA OKs ADAP's Groundbreaking Cell Therapy, ME Rebuffs CEO Bid

It was a busy week for the biotech sector, with numerous data presentations by biotech companies at healthcare conferences. Regular pipeline news was also in the spotlight.
Recap of the Week’s Most Important Stories:
GSK Down on Zantac Litigation: GSK GSK suffered a setback in the ongoing Zantac litigation. The company issued a statement disagreeing with the ruling by the Delaware State Court that allows the numerous lawsuits related to Zantac to move forward for jury trials. The lawsuits claim that the heartburn drug Zantac (ranitidine) causes cancer. The Delaware State Court’s decision also contradicts the Federal Court’s multidistrict litigation (MDL) ruling (in December 2022), which dismissed all cases alleging five cancer types.
In the MDL, plaintiffs identified five different types of cancers (liver, bladder, pancreatic, esophageal and stomach). The court dismissed all MDL cases alleging the five cancers. GSK stated that as per scientific consensus, there was no consistent or reliable evidence to show that ranitidine increases the risk of any cancer. GSK said that it will continue to vigorously defend itself against all claims.
The company also announced positive results from an interim analysis of the phase III DREAMM-8 head-to-head trial. The trial is evaluating Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone, compared to a combination of bortezomib and pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma, previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen. The patients had documented disease progression during or after their most recent therapy. Results showed statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival.
Biogen’s Drug Approval: Biogen BIIB announced that the European Commission (EC) has granted marketing approval to Qalsody (tofersen) for treating patients with amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutation. The marketing authorization was granted to Qalsody under exceptional circumstances, wherein a treatment is deemed to have a positive benefit/risk assessment but gathering comprehensive data is difficult due to the rarity of the condition. The EC has also maintained an orphan designation for Qalsody.
The approval was based on data from the phase III VALOR study. It was expected as the Committee for Medicinal Products for Human Use (CHMP) of the EMA rendered a positive opinion recommending a marketing authorization under exceptional circumstances for Qalsody for SOD1-ALS in February. Biogen in-licensed rights to tofersen from Ionis Pharmaceuticals under a collaborative development and license agreement.
Biogen Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
VIR Up on Study Results: Vir Biotechnology, Inc.’s VIR shares rose after it announced new preliminary data from its phase II SOLSTICE study. The study is evaluating the safety, tolerability and efficacy of tobevibart and investigational small interfering ribonucleic acid elebsiran for the treatment of people living with chronic hepatitis delta.
Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, and reduce the level of virions and subviral particles in the blood. Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid. One cohort is evaluating the combination of tobevibart and elebsiran, dosed every four weeks with a second cohort evaluating tobevibart monotherapy every two weeks. Approximately 50% of the participants have compensated cirrhosis.
The preliminary data from this mid-stage study showed treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. Vir Biotechnology is on track to report additional 24-week treatment data for approximately 60 SOLSTICE participants in the fourth quarter of 2024.
Amgen Study Updates: Amgen AMGN announced that its late-stage study on Uplizna (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD) was successful.
The randomized, double-blind, placebo-controlled, parallel-group, multicenter MITIGATE study was designed to evaluate the efficacy and safety of Uplizna compared to placebo in reducing the risk of flares in adults with IgG4-RD.
After a screening period of up to 28 days, patients were randomized (1:1) to receive 300 mg intravenous of Uplizna or placebo on days 1, 15, and week 26 after premedication, and followed for the 52-week randomized control period. This drug is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) in the United States, EU and many other countries.
The study met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints (annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission) were also achieved. Consequently, Amgen is planning to file for approval of the drug in the United States.
Viking’s NASH Data: Viking Therapeutics VKTX announced positive 52-week histologic data from the phase IIb VOYAGE study that evaluated VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The VOYAGE study achieved its secondary endpoints evaluating histologic changes assessed by hepatic biopsy after 52 weeks of treatment with VK2809 when compared with placebo. This study evaluated four different doses of VK2809 — 1 mg, 2.5 mg, 5 mg and 10mg.
Results showed that roughly 63-75% patients who took VK2809 achieved NASH resolution (meaning the disease symptoms disappeared) while experiencing no worsening of fibrosis. In contrast, only 29% of patients who received a placebo achieved similar results. 44-57% of the patients who took the drug showed at least a one-stage improvement in fibrosis without worsening of NASH compared to 34% for placebo. Overall, 40-50% of patients who received VK2809 achieved NASH resolution and at least a one-stage improvement in fibrosis compared to 20% in the placebo group.
This study has already achieved its primary endpoint – NASH patients who received VK2809 achieved a statistically significant reduction in liver fat content following 12 weeks of treatment. However, the company’s shares were down despite the upbeat data.
Performance
The Nasdaq Biotechnology Index has gained 5.47% in the past five trading sessions and Biogen’s shares have risen 10.41% during the same time frame. In the past six months, shares of MRNA have rallied 97.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIBs Acquisition, PTCT, LRMR Gain on Updates & More News)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
Highest Returns for Any Asset Class
It’s not even close. Despite ups and downs, Bitcoin has been more profitable for investors than any other decentralized, borderless form of money.
No guarantees for the future, but in the past three presidential election years, Bitcoin’s returns were as follows: 2012 +272.4%, 2016 +161.1%, and 2020 +302.8%. Zacks predicts another significant surge in months to come.
Hurry, Download Special Report – It’s FREE >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report
Vir Biotechnology, Inc. (VIR) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Biotech Stock Roundup: GSK's Litigation Update, BIIB's Drug Approval & Other Updates

In trading on Friday, shares of Vir Biotechnology Inc (Symbol: VIR) crossed above their 200 day moving average of $10.24, changing hands as high as $10.59 per share. Vir Biotechnology Inc shares are currently trading up about 11.7% on the day. The chart below shows the one year performance of VIR shares, versus its 200 day moving average:
Looking at the chart above, VIR's low point in its 52 week range is $7.61 per share, with $27.48 as the 52 week high point — that compares with a last trade of $10.35.
Click here to find out which 9 other stocks recently crossed above their 200 day moving average »
Energy Stock Dividends
Viatris MACD
INBK Dividend Growth Rate
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

VIR Crosses Above Key Moving Average Level

Looking at the underlying holdings of the ETFs in our coverage universe at ETF Channel, we have compared the trading price of each holding against the average analyst 12-month forward target price, and computed the weighted average implied analyst target price for the ETF itself. For the iShares Core S&P Small-Cap ETF (Symbol: IJR), we found that the implied analyst target price for the ETF based upon its underlying holdings is $114.91 per unit.
With IJR trading at a recent price near $104.86 per unit, that means that analysts see 9.58% upside for this ETF looking through to the average analyst targets of the underlying holdings. Three of IJR's underlying holdings with notable upside to their analyst target prices are Vir Biotechnology Inc (Symbol: VIR), Arcus Biosciences Inc (Symbol: RCUS), and REGENXBIO Inc (Symbol: RGNX). Although VIR has traded at a recent price of $10.08/share, the average analyst target is 195.14% higher at $29.75/share. Similarly, RCUS has 119.84% upside from the recent share price of $19.73 if the average analyst target price of $43.38/share is reached, and analysts on average are expecting RGNX to reach a target price of $38.00/share, which is 119.65% above the recent price of $17.30. Below is a twelve month price history chart comparing the stock performance of VIR, RCUS, and RGNX:
Below is a summary table of the current analyst target prices discussed above:
Are analysts justified in these targets, or overly optimistic about where these stocks will be trading 12 months from now? Do the analysts have a valid justification for their targets, or are they behind the curve on recent company and industry developments? A high price target relative to a stock's trading price can reflect optimism about the future, but can also be a precursor to target price downgrades if the targets were a relic of the past. These are questions that require further investor research.
Funds Holding EXTR
PAYX Historical Earnings
PICB market cap history
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Analysts See 10% Upside For The Holdings of IJR

(RTTNews) - Vir Biotechnology Inc. (VIR) Wednesday announced strategic initiatives to cut operating expenses, which include reducing workforce by about 12% and closing two research facilities.
R&D facilities in St. Louis, Missouri and Portland, Oregon will be closed in 2024. Research activities will continue at the company's sites in San Francisco, California and Bellinzona, Switzerland.
Approximately 12% or 75 positions will be eliminated, which includes reductions from the company's discontinuation of its innate immunity small molecule group which was initiated in the third quarter of 2023. The reductions will be substantially complete by the first quarter of 2024.
Vir expects to reduce its cost structure by at least $40 million annually. The company reported $1.7 billion in cash, cash equivalents and investments in the third quarter of 2023.
Vir is expecting charges of $30 million to $40 million related to facility closures and severance charges.
"After a thorough review and with a strong focus on our mission, we are making purpose-led changes to align Vir with our goals to deliver sustainable growth and ensure we are well-positioned for the future," Chief Executive Marianne De Backer said.
In the second quarter of 2024, Vir expects to report new clinical data from its ongoing Phase 2 trial evaluating its monoclonal antibody tobevibart and its siRNA elebsiran for the treatment of chronic hepatitis delta.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Vir Biotechnology To Reduce Workforce By 12%, To Close 2 Research Facilities

Looking at the underlying holdings of the ETFs in our coverage universe at ETF Channel, we have compared the trading price of each holding against the average analyst 12-month forward target price, and computed the weighted average implied analyst target price for the ETF itself. For the Vanguard S&P Small-Cap 600 ETF (Symbol: VIOO), we found that the implied analyst target price for the ETF based upon its underlying holdings is $103.95 per unit.
With VIOO trading at a recent price near $91.74 per unit, that means that analysts see 13.30% upside for this ETF looking through to the average analyst targets of the underlying holdings. Three of VIOO's underlying holdings with notable upside to their analyst target prices are Vir Biotechnology Inc (Symbol: VIR), Arcus Biosciences Inc (Symbol: RCUS), and Xencor, Inc (Symbol: XNCR). Although VIR has traded at a recent price of $9.70/share, the average analyst target is 206.86% higher at $29.75/share. Similarly, RCUS has 169.91% upside from the recent share price of $16.07 if the average analyst target price of $43.38/share is reached, and analysts on average are expecting XNCR to reach a target price of $39.67/share, which is 110.88% above the recent price of $18.81. Below is a twelve month price history chart comparing the stock performance of VIR, RCUS, and XNCR:
Below is a summary table of the current analyst target prices discussed above:
Are analysts justified in these targets, or overly optimistic about where these stocks will be trading 12 months from now? Do the analysts have a valid justification for their targets, or are they behind the curve on recent company and industry developments? A high price target relative to a stock's trading price can reflect optimism about the future, but can also be a precursor to target price downgrades if the targets were a relic of the past. These are questions that require further investor research.
BDC Baby Bonds and Preferreds
Top Ten Hedge Funds Holding EMLD
EWAS Videos
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.