GSK (NYSE:GSK) Stock

In the pharmaceutical industry, GSK ranks as one of the largest firms by total sales. The company wields its might across several therapeutic classes, including respiratory, cancer, antiviral, and vaccines. GSK uses joint ventures to gain additional scale in certain markets like HIV.

GlaxoSmithKline

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GSK&#39;s Penmenvy wins FDA approval to protect against five meningococcal serogroups. The CDC panel will vote on usage recommendations on Feb. 26.

FDA Approves GSK&#39;s 5-in-1 Meningococcal Vaccine For Adolescents Ahead Of CDC Advisory Committee Vote Meeting Next Week (UPDATED)

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Ken Griffin&#39;s Citadel hedge fund places £305M short bet against GSK, with skepticism over long-term pipeline and recent stock rally.

Ken Griffin&#39;s Citadel Places Big Short Bet Against GSK - Here&#39;s What It Means for Investors

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A Nevada dairy worker who initially tested positive for bird flu is currently experiencing mild symptoms, including &#34;pink eye.&#34;

Deadly Bird Flu Strain Detected In Nevada Man: 4 Stocks To Watch (CORRECTED)

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

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The China National Medical Products Administration Has Accepted For Review GSK's New Drug Application For Nucala (Mepolizumab) As An Add-on Maintenance Treatment For Patients With Chronic Obstructive Pulmonary Disease With An Eosinophilic Phenotype

Editor&#8217;s Note: The story has been updated to correct the FDA approval date to Friday, February 14
On Friday, February 14, the FDA approved GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25. 
The vaccine targets five major serogroups of&nbsp;Neisseria meningitidis&nbsp;(A, B, C, W, and Y), which commonly cause invasive meningococcal disease (IMD).
The vaccine <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/" rel="noreferrer noopener">combines</a> the antigenic components of GSK&#8217;s two well-established meningococcal vaccines,&nbsp;Bexsero&nbsp;(Meningococcal Group B&nbsp;Vaccine) and&nbsp;Menveo&nbsp;(Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197&nbsp;Conjugate Vaccine).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/02/43492835/gsk-launches-share-buyback-of-around-25-billion-after-better-than-expected-q4-earnings-raises-long-term-annual-sales-forecast-to-over-50-billion" rel="noreferrer noopener">GSK Q4 Earnings: Revenue And EPS Beat, Initiates $2.5 Billion Stock Buyback, Raises Long-Term Annual Sales Forecast To Over $50 Billion</a>
The regulatory&nbsp;application&nbsp;was supported by results from two phase 3 trials, which evaluated the vaccine&#8217;s safety, tolerability, and immune response in over 4,800 participants aged 10-25.&nbsp;
The safety data demonstrated that the vaccine has a safety profile consistent with GSK&#8217;s licensed meningococcal vaccines.
Integrating GSK&#8217;s MenABCWY vaccine into healthcare provider practices could simplify meningococcal vaccination delivery and help protect more U.S. adolescents against the five common disease-causing serogroups—A, B, C, W, and Y—for which the US Centers for Disease Control and Prevention (CDC) have issued recommendations.
Although MenB is the leading cause of IMD among this population, less than 13% receive the recommended two-dose vaccination series; around 32% receive at least one dose. GSK manufactures three of every four MenB doses currently administered in the U.S., positioning the company well to lead in the U.S. market as MenB-containing vaccinations must be completed with the same manufacturer&#8217;s MenB vaccine.
At its meeting on February 26, 2025, the CDC&#8217;s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations for the appropriate use of GSK&#8217;s MenABCWY vaccine in adolescents and young adults.
Price Action: GSK stock is up 0.64% at $36.41 during the premarket session on last check Tuesday.
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FDA Approves GSK's 5-in-1 Meningococcal Vaccine For Adolescents Ahead Of CDC Advisory Committee Vote Meeting Next Week (UPDATED)

<a href="https://www.benzinga.com/topic/ken-griffin">Ken Griffin</a>'s <a href="https://www.benzinga.com/topic/citadel-securities">hedge fund Citadel</a> has placed a £305 million ($390 million) short bet against GSK PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), marking the largest wager against the UK pharma giant in over a decade, <a href="https://www.ft.com/content/6520c6eb-4a30-4909-9c86-1b6b2e471743">reported</a> the Financial Times. 
The position, disclosed to the UK's Financial Conduct Authority, amounts to 0.51% of GSK's outstanding shares.
<h2 class="wp-block-heading">GSK's Rally Faces A Reality Check</h2>
GSK stock has climbed 8.20% in the past month, fueled by a £2 billion ($2.5 billion approx.) stock buyback and strong HIV and cancer drug sales. Yet, it still trails peers. 
Over the past five years, GSK shares have declined 17.53%, while the S&amp;P 500 pharmaceutical index has surged 45%. Griffin's short signals skepticism over the company's long-term pipeline, especially as its HIV drugs near a patent cliff.
Read Also: <a href="https://www.benzinga.com/general/biotech/25/02/43638136/goldman-sachs-turns-bearish-on-vaccine-maker-dynavax-amid-shingles-and-hepatitis-b-uncertainty">Goldman Sachs Turns Bearish On Vaccine Maker Dynavax Amid Shingles And Hepatitis B Uncertainty</a>
<h2 class="wp-block-heading">Hedge Funds, Analysts Are Split</h2>
This isn't the first time hedge funds have circled GSK. In 2021, activist investor Elliott Management pushed for a leadership shake-up. 
Meanwhile, JPMorgan analysts view GSK's latest earnings and guidance as "positive," but question the buyback's timing. Barclays called it "unexpected," while Jefferies deemed it "well received."
<h2 class="wp-block-heading">Takeaways For Investors</h2>
GSK's challenges have led to mixed bets on its future, but investors seeking exposure to Big Pharma without GSK's risks may look at industry leaders like Eli Lilly &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>). 
Alternatively, the iShares U.S. Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IHE#NYSE">IHE</a>) and SPDR S&amp;P Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XPH#NYSE">XPH</a>) provide diversified exposure.
With Citadel betting against GSK, the stock could see increased volatility—making it one to watch.
Read Next: 
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<li><a href="https://www.benzinga.com/general/health-care/25/02/43598644/deadly-bird-flu-strain-detected-in-nevada-man-4-stocks-to-watch">Deadly Bird Flu Strain Detected In Nevada Man: 4 Stocks To Watch</a></li>
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Ken Griffin's Citadel Places Big Short Bet Against GSK - Here's What It Means for Investors

<a href="https://www.cdc.gov/mmwr/volumes/74/wr/mm7404a2.htm" title="https://www.cdc.gov/mmwr/volumes/74/wr/mm7404a2.htm">https://www.cdc.gov/mmwr/volumes/74/wr/mm7404a2.htm</a>

U.S. CDC Report: Evidence Found Of Recent Bird Flu Infections Among 3 Cattle Veterinarians

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for&nbsp;APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals who are HIV-1 negative.1
ViiV Healthcare is committed to ensuring timely public access for APRETUDE to help reduce the risk of sexually acquired HIV-1 infection and make progress towards global targets of ending HIV by 2030, which Canada endorsed.2,3&nbsp;ViiV Healthcare recognizes the pCPA's efforts and shared commitment to achieving this goal. This milestone underscores the need to expedite public reimbursement and as such, ViiV Healthcare looks forward to working with provincial and territorial governments and other stakeholders to make APRETUDE available through public drug plans.
APRETUDE is the first and only long-acting injectable approved in Canada and is indicated for at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. APRETUDE for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in reducing the risk of HIV acquisition in two clinical trials, giving Canadians more options for PrEP.1&nbsp;

ViiV Healthcare And The Pan-Canadian Pharmaceutical Alliance Finalize Negotiations For APRETUDE For HIV-1 Pre-Exposure Prophylaxis

Editor's Note: This article has been updated to reflect that GSK acquired full rights to CureVac&#8217;s bird flu vaccine candidate.
A Nevada dairy worker has screened positive for the D1.1 strain of bird flu associated with a Louisiana man's death in January, according to a CNN <a href="https://www.cnn.com/2025/02/08/health/bird-flu-variant-nevada-human-case/index.html">report</a>. The Centers for Disease Control and Prevention is working Monday to confirm<a href="https://www.benzinga.com/general/health-care/25/02/43549057/deadly-bird-flu-strain-hits-dairy-cows-could-make-covid-seem-like-a-walk-in-the-park-expert-says"> the initial positive test.</a>
The Details: The Nevada dairy worker who has initially tested positive is currently experiencing mild symptoms, including conjunctivitis or "pink eye," which appears to be a common symptom in recent human infections.&nbsp;
Last week, the U.S. Department of Agriculture said six dairy herds in Nevada<a href="https://www.benzinga.com/general/health-care/25/02/43549057/deadly-bird-flu-strain-hits-dairy-cows-could-make-covid-seem-like-a-walk-in-the-park-expert-says"> tested positive</a> for the D1.1 strain of bird flu, marking the first time the variant of the H5N1 virus was detected in cattle.&nbsp;
Read Next: <a href="https://www.benzinga.com/general/social-media/25/02/43535256/palantir-adds-elon-musks-ai-chatbot-grok-to-aip">Palantir Adds Elon Musk&#8217;s AI Chatbot Grok To AIP</a>
The<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html"> current public health</a> risk remains low, according to the CDC. The agency is using flu surveillance systems to monitor for H5 bird flu activity in people.&nbsp;
In January, President Donald Trump <a href="https://www.benzinga.com/general/health-care/25/01/43194764/trump-administration-halts-all-communications-from-the-centers-for-disease-control-as-bird-flu-spreads">ordered </a>a stop to all communications from CDC. Its website currently displays a banner stating that the site is being "modified to comply with President Trump's Executive Orders."
The CDC resumed publishing its weekly <a href="https://www.cdc.gov/mmwr/index2025.html?ACSTrackingID=USCDC_921-DM144964&amp;ACSTrackingLabel=This%20Week%20in%20MMWR:%20Vol.%2074,%20February%206,%202025&amp;deliveryName=USCDC_921-DM144964">scientific report</a>, the Morbidity and Mortality Weekly Report, last Thursday after being paused for the previous two weeks.&nbsp;
What Else: The H5N1 avian flu continues to spread in wild bird populations as well as in domestic flocks. As many as 15 birds at the Queens and Bronx zoos died last week as a result of the bird flu and a zoo spokesperson<a href="https://gothamist.com/news/bird-flu-suspected-in-deaths-across-multiple-species-at-queens-and-bronx-zoos"> told</a> Gothamist that "vulnerable bird species&#8221; have been moved to protected areas as vets work with city, state and federal regulators.&nbsp;
New York Governor Kathy Hochul has ordered live poultry markets in New York City, Westchester and Long Island to close after several bird flu cases were detected in Queens, Brooklyn and the Bronx last week.&nbsp;
According to the National Emerging Special Pathogens Training &amp; Education Center, more than 60 million poultry have died or<a href="https://netec.org/2023/01/30/situation-report-highly-pathogenic-avian-influenza-ah5n1/"> been culled</a> due to bird flu since the outbreak began in 2022. More than 20 million egg-laying chickens were culled in the last quarter of 2024 alone, creating a large impact on the U.S. poultry industry.&nbsp;
Stocks To Watch: With another human case of bird flu likely having been detected, investors may want to monitor the following stocks that are connected with bird flu vaccines.
Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) in January received an additional $590 million award from the U.S. Department of Health and Human Services to accelerate the development of its mRNA-based influenza vaccines, including bird flu.
GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), which acquired full rights to the bird flu vaccine candidate from CureVac BV (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) in July 2024, has initiated a Phase I/II study on its development. Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) also has bird flu vaccine candidates in clinical trials.
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<li><a href="https://www.benzinga.com/news/earnings/25/02/43512137/ford-shares-skid-after-q4-report-details">Ford Shares Skid After Q4 Report: Details</a></li>
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Goldman Sachs downgraded Dynavax Technologies Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DVAX#NASDAQ">DVAX</a>) reflecting updated views and recent competitive <a target="_blank" href="https://www.benzinga.com/quote/DVAX" rel="noreferrer noopener">dynamics for vaccines</a>.
Goldman Sachs analyst Paul Choi has downgraded Dynavax to Sell from Neutral and cut the <a target="_blank" href="https://www.benzinga.com/quote/DVAX/analyst-ratings" rel="noreferrer noopener">price target from $15 to $12</a>. He notes growing competition in the shingles vaccine market, which could reduce the potential value of the Z-1018 program and add uncertainty to its long-term revenue.
Potential convenience improvements come from GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Shingrix with the company's pre-filled syringes, which have been accepted for review by <a target="_blank" href="https://www.benzinga.com/25/02/43492835/gsk-launches-share-buyback-of-around-25-billion-after-better-than-expected-q4-earnings-raises-long-term-annual-sales-forecast-to-over-50-billion" rel="noreferrer noopener">both the FDA and EMA</a> (U.S. decision expected by 20 June).
Dynavax is conducting a Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to GSK's Shingrix in 441 healthy adults aged 50 to 69.
Choi also points to uncertain demand for repeat hepatitis B vaccinations in the 2030s, which may impact Heplisav-B's outlook beyond its peak sales. Despite its market share gains, questions remain about the FDA and ACIP's regulatory stance on vaccines in the U.S.
Last month,&nbsp;Dynavax announced preliminary HEPLISAV-B net product revenue of&nbsp;$268 million&nbsp;for 2024, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/n42945098/dynavax-announces-preliminary-unaudited-fourth-quarter-and-full-year-2024-financial-highlights" rel="noreferrer noopener">up 26% year-over-year</a>.
HEPLISAV-B net product revenue reached&nbsp;$71 million&nbsp;for the fourth quarter of 2024, up 39%.
In May 2024, the FDA issued a Complete Response Letter stating that the application did not provide sufficient data to fully evaluate the effectiveness or safety of a four-dose <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38818397/fda-declines-to-approve-expanded-use-of-dynavaxs-hepatitis-b-vaccine-in-hemodialysis-patients" rel="noreferrer noopener">regimen of HEPLISAV-B</a>.&nbsp;
Dynavax is expected to report fourth-quarter earnings <a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/n43548293/dynavax-to-report-fourth-quarter-and-full-year-2024-financial-results-and-host-conference-call-on-" rel="noreferrer noopener">on 20 February</a>.
As per data from Benzinga Pro, analysts estimate Q4 adjusted EPS of $0.04, with sales of $72.92 million.
Analysts forecast 2024 sales of $278.13 million and <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">adjusted EPS of $0.12</a>.
Price Action: DVAX stock is down 4.13% at $12.66 at last check Tuesday.
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DVAX

Goldman Sachs Turns Bearish On Vaccine Maker Dynavax Amid Shingles And Hepatitis B Uncertainty

U.S. stocks were mostly lower, with the Nasdaq Composite falling around 100 points on Wednesday.
Shares of Electronic Arts Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EA#NASDAQ">EA</a>) rose sharply during Wednesday's session after the company reported better-than-expected third-quarter EPS results. B of A Securities raised its price target on the stock <a href="https://www.benzinga.com/25/02/43492624/electronic-arts-sees-strong-q3-earnings-boosted-by-ea-sports-fc-success-25-billion-shareholder-return-plan">from $130 to $132</a>.
Electronic Arts posted net bookings of $2.215 billion and GAAP earnings of $1.11 per share, beating estimates of $1.07 per share.
Electronic Arts shares jumped 5.4% to $127.83 on Wednesday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>BigBear.ai Holdings Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BBAI#NYSE">BBAI</a>) shares surged 33.99% to $6.58. BigBear.ai won Department of Defense contract to prototype near-peer adversary geopolitical risk analysis for Chief Digital and Artificial Intelligence Office.</li>
<li>Criteo SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRTO#NASDAQ">CRTO</a>) shares jumped 20% to $46.06 following better-than-expected fourth-quarter reported financial results and an increase in its share buyback authorization program.</li>
<li>Mercury Systems Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRCY#NASDAQ">MRCY</a>) gained 19% to $49.68 after the company reported better-than-expected quarterly financial results.</li>
<li>Tilray Brands Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TLRY#NASDAQ">TLRY</a>) gained 17% to $1.16.</li>
<li>SSR Mining Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SSRM#NASDAQ">SSRM</a>) gained 16.8% to $9.57 after RBC Capital upgraded the stock from Underperform to Sector Perform and raised its price target from $5.5 to $8.</li>
<li>Mattel Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MAT#NASDAQ">MAT</a>) rose 12.7% to $20.37 following better-than-expected fourth-quarter financial results. Jefferies upgraded the stock from Hold to Buy following the report.</li>
<li>Embraer SA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ERJ#NYSE">ERJ</a>) gained 11.6% to $44.48 after its executive jets subsidiary announced a purchase agreement with Flexjet in which it secured a $7 billion order.</li>
<li>Johnson Controls International PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JCI#NYSE">JCI</a>) gained 11.2% to $85.97 after the company reported better-than-expected first-quarter financial results and FY25 outlook. They also appointed Joakim Weidemanis as next CEO.</li>
<li>Mueller Water Products Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MWA#NYSE">MWA</a>) gained 10.8% to $25.60 following better-than-expected quarterly reported financial results. Additionally, the company raised its FY25 adjusted EBITDA guidance and issued FY25 revenue guidance above estimates.</li>
<li>Champion Homes Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SKY#NYSE">SKY</a>) gained 9.5% to $101.61 after the company reported better-than-expected quarterly financial results.</li>
<li>Tempus AI Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEM#NASDAQ">TEM</a>) rose 8.7% to $67.21 after TD Cowen reinstated a Buy rating on the stock and announced a price target of $74.</li>
<li>Bloom Energy Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BE#NYSE">BE</a>) gained 8.2% to $25.02.</li>
<li>GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) gained 7.8% to $37.52 after the company reported better-than-expected fourth-quarter financial results.</li>
<li>Fiserv Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FI#NYSE">FI</a>) shares surged 7.1% to $229.37 following better-than-expected quarterly reported financial results.</li>
<li>Powell Industries Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/POWL#NASDAQ">POWL</a>) gained 5.8% to $246.82. Powell Industries raised its quarterly dividend to $0.2675 per share.</li>
<li>BioNTech SE – ADR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) rose 5.7% to $123.76.</li>
<li>Toyota Motor Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TM#NYSE">TM</a>) gained 3.8% to $194.68 after the company reported a year-over-year increase in third-quarter financial results and issued FY25 guidance above estimates.</li>
</ul>
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Electronic Arts Posts Upbeat Earnings, Joins Mattel, Johnson Controls, Mueller Water Products And Other Big Stocks Moving Higher On Wednesday

Wednesday,&nbsp;GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)&nbsp;reported fourth-quarter sales of $10.40 billion (8.12 billion Sterling Pounds), up 1% year-over-year and up 4% on constant currency. The analysts&nbsp;<a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">estimated sales of $9.58 billion</a>.
Vaccine sales fell 14% (-11% at constant currency) to 2.21 billion pounds, primarily impacted by lower demand for Arexvy related to a more limited ACIP recommendation in the U.S. and channel inventory consumption compared to launch year stocking in 2023. Arexvy sales reached 158 <a target="_blank" href="https://www.benzinga.com/25/01/42873977/safety-labels-updated-for-pfizer-and-gsks-rsv-vaccines-fda-adds-warning-for-rare-neurological-disorder" rel="noreferrer noopener">million pounds, down 70%</a>.
Meningitis vaccines had their strongest year of sales to date, with double-digit growth across all regions of 295 million. Established vaccine sales of 806 million, growing internationally and in the U.S.
Vaccines performance was also adversely <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-delivers-strong-2024-performance-with-further-improvement-to-long-term-growth-outlook/" rel="noreferrer noopener">impacted</a> due to COVID-19 solution sales and U.S. CDC stockpile replenishments in 2023, each impacting full year growth by 1 percentage point.
Shingrix sales reached 848 million pounds, down 7% (-4% at constant currency).
Also Read:&nbsp;<a target="_blank" href="https://www.benzinga.com/general/health-care/25/01/43257413/trumps-executive-order-leads-to-cdc-halting-collaboration-with-who-amid-h5n9-bird-flu-discovery-and-rfk-jrs-senate-hearings" rel="noreferrer noopener">Moderna, Pfizer Surge Amid CDC-WHO Split And Bird Flu; RFK Jr. Nomination Looms — A Recipe For The Perfect Storm?</a>
Specialty Medicine sales increased 14% to 3.29 billion pounds. HIV drug revenues increased by 11% to&nbsp;1.97 billion pounds. General Medicines sales rose by 1% to&nbsp;2.61 billion pounds.
Trelegy (asthma drug) sales reached 669 million pounds, up 14%.
The company reported core EPS of $0.59 (23.2 pence), down 10%&nbsp;in&nbsp;constant currency and 20% on a reported basis, beating the consensus of $0.43.
Stock Buyback: GSK also said it would buy back 2 billion pounds of shares over the next 18 months.
Guidance:&nbsp;GSK expects 2025 sales to grow between 3% and 5%, with core earnings per share growing between 6% and 8%, including the benefit from the share buyback.
Specialty Medicines sales are expected to increase by a low double-digit percent, Vaccine turnover is expected to decrease by a low single-digit percent, and General Medicines are expected to be broadly stable.
The pharma giant boosted its long-term growth outlook and now expects over 40 billion pounds of sales in 2031, <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43010436/gsk-highlights-new-approvals-vaccine-momentum-at-jp-morgan-healthcare-conference" rel="noreferrer noopener">up from 38 billion pounds</a>.
The increase reflects the inclusion of Blenrep, the significant phase 3 progress since last year and multiple launch opportunities in the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41986367/gsk-raises-prospects-for-withdrawn-blood-cancer-drug-blenrep-to-return-to-us-market-heres-why" rel="noreferrer noopener">2025 to 2031 period</a>.
Price Action:&nbsp;At last check on Wednesday, GSK stock was up 6.20% ro $37.01 during the premarket session.
Read Next:
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Photo by HJBC via Shutterstock

Earnings

Guidance

Buybacks

GSK Q4 Earnings: Revenue And EPS Beat, Initiates $2.5 Billion Stock Buyback, Raises Long-Term Annual Sales Forecast To Over $50 Billion

WIIM

GSK shares are trading higher after the company reported better-than-expected Q4 financial results.

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Earnings Scheduled For February 5, 2025

2025 Guidance&nbsp;
GSK provides its full-year guidance at constant exchange rates (CER).&nbsp;
<ul>
<li>Turnover is expected to increase between 3 to 5 per cent&nbsp;</li>
<li>Core operating profit is expected to increase between 6 to 8 per cent&nbsp;</li>
<li>Core earnings per share is expected to increase between 6 to 8 per cent&nbsp;</li>
</ul>
This guidance is supported by the following turnover expectations for full-year 2025 at CER&nbsp;
<ul>
<li>Specialty Medicines – expected increase of a low double-digit per cent in turnover&nbsp;</li>
<li>Vaccines – expected decrease of a low single-digit per cent in turnover&nbsp;</li>
<li>General Medicines – expected to be broadly stable for turnover</li>
</ul>

GSK Expects 2025 Turnover Growth Of 3%-5%, Core EPS Rise Of 6%-8%, And Core Operating Profit Growth Of 6%-8%

GSK (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) reported quarterly earnings of $0.59 per share which beat the analyst consensus estimate of $0.43 by 38.37 percent. This is a 17.13 percent decrease over earnings of $0.72 per share from the same period last year. The company reported quarterly sales of $10.404 billion which beat the analyst consensus estimate of $9.579 billion by 8.61 percent. This is a 3.37 percent increase over sales of $10.065 billion the same period last year.

Earnings Beats

GSK Q4 2024 Adj. EPS $0.59 Beats $0.43 Estimate, Sales $10.404B Beat $9.579B Estimate

Trump Health Sec Nominee Kennedy Says He Will Support Development Of Vaccines For Bird Flu

<a href="https://www.youtube.com/watch?v=e040JFe7bK0">https://www.youtube.com/watch?v=e040JFe7bK0</a>
&nbsp;

Trump Health Sec Nominee Kennedy Says He Will Not Pause Research On Bird Flu; Says He Will "Devote The Appropriate Resources To Preventing Pandemics" With Respect To Bird Flu

The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
 &nbsp;

The European Medicines Agency Has Accepted For Review GSK's Marketing Authorization Application For The Use Of Depemokimab In Two Indications

Global health concerns escalated Monday as the U.S. Centers for Disease Control and Prevention reportedly halted collaboration with the World Health Organization, coinciding with the discovery of a rare H5N9 bird flu strain in California and upcoming Senate confirmation hearings for vaccine skeptic Robert F. Kennedy Jr.
What Happened: The developments sent ripples through healthcare stocks, with vaccine manufacturers showing mixed reactions. Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) edged up 0.58%, while Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) gained 2.95% amid heightened focus on potential bird flu preparedness.
CDC official John Nkengasong&#8216;s Sunday memo, <a href="https://apnews.com/article/cdc-who-trump-548cf18b1c409c7d22e17311ccdfe1f6">viewed</a> by The Associated Press, ordered an immediate stop to all WHO collaborations, catching health experts off guard as the U.S. faces multiple health challenges, including 13 measles outbreaks this year.
The first U.S. H5N9 outbreak, detected at a Merced County duck farm alongside the more common H5N1 strain, led to the culling of 119,000 birds, Reuters reported.
The discovery comes as egg prices nationwide hit $4.15 per dozen in December. The United States Department of Agriculture is projecting a further 20% increase this year due to ongoing bird flu impacts, according to a separate Associated Press <a href="https://apnews.com/article/egg-prices-bird-flu-poultry-inflation-9ea9934e20e3fe393abb1bb85aa31c30">report</a>.
The timing is particularly significant as Kennedy, known for his vaccine skepticism, faces Senate confirmation hearings this week for Health and Human Services Secretary. His potential appointment has already influenced market sentiment, with some vaccine stocks experiencing volatility.
&#8220;The concurrent WHO separation and emerging health threats create significant uncertainty for healthcare investors,&#8221; said Dr. Jeffrey Klausner, a University of Southern California public health expert.
See Also: <a href="https://www.benzinga.com/markets/equities/25/01/43256425/nvidia-says-deepseek-an-illustration-of-how-new-ai-models-can-be-created-while-being-export-control-compliant-amid-600-billion-market-value-plunge">Nvidia Says DeepSeek An &#8216;Illustration&#8217; Of How New AI Models Can Be Created While Being Export-Control Compliant Amid $600 Billion Market Value Plunge</a>
Why It Matters: The healthcare sector&#8217;s response reflects broader market concerns. The iShares Genomics Immunology and Healthcare ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IDNA#NASDAQ">IDNA</a>) has gained 1.2% year-to-date, while <a href="https://www.benzinga.com/general/biotech/25/01/42882233/bird-flu-sparks-vaccine-stock-surge-etfs-to-watch-as-h5n1-outbreak-intensifies">major vaccine producers</a> maintain substantial government contracts for flu preparedness.
Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), GlaxoSmithKline PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), and other manufacturers secured $72 million in federal funding last October for bird flu vaccine production. Moderna separately received $176 million from BARDA for mRNA-based H5N1 vaccine development.
The CDC decision follows President Donald Trump&#8216;s executive order to withdraw from WHO, though the complete withdrawal requires congressional <a href="https://www.benzinga.com/25/01/43125408/trump-signs-order-to-withdraw-us-from-who-again-cites-funding-governance-concerns">approval and a one-year notice period</a>.
Read Next: 
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<li><a href="https://www.benzinga.com/trading-ideas/movers/25/01/43256454/bitcoin-ethereum-dogecoin-recover-as-deepseek-troubles-mount-for-us-tech-stocks-analyst-suggests-btc-could-hit-fresh-highs-over-upcoming-two-weeks">Bitcoin, Ethereum, Dogecoin Recover As DeepSeek Troubles Mount For US Tech Stocks: Analyst Suggests BTC Could Hit Fresh Highs Over Upcoming Two Weeks</a></li>
</ul>
Image Via Shutterstock 
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Equities

IDNA

Moderna, Pfizer Surge Amid CDC-WHO Split And Bird Flu; RFK Jr. Nomination Looms — A Recipe For The Perfect Storm?

GSK shares are trading higher after the company announced the European Medicines Agency will review Shingrix for regulatory application.

The European Medicines Agency Has Accepted For Review The Regulatory Application Of A Prefilled Syringe Presentation Of Shingrix, GSK's Recombinant Zoster Vaccine

As the bird flu virus continues to spread through the United States among poultry, dairy cows and several recent human cases among poultry workers, on Tuesday the Trump administration ordered all communications from the Centers for Disease Control <a href="https://www.benzinga.com/general/biotech/25/01/42854890/us-records-first-human-bird-flu-death-high-levels-of-respiratory-illnesses-vaccine-stocks-rally">and Prevention to stop</a>.&nbsp;
The Details: Acting Secretary of the U.S. Department of Health and Human Services Dorothy Fink followed by halting all reports from health agencies like the CDC, Food and Drug Administration and the National Institutes of Health on Tuesday, according to <a href="https://www.washingtonpost.com/health/2025/01/22/trump-health-communications-cdc-hhs-fda/56777086-d8e4-11ef-85a9-331436ec61e9_story.html">a report</a> from the Washington Post.&nbsp;
In a memo obtained by the Associated Press, Fink communicated that an "immediate pause" was ordered on regulations, guidance, announcements, press releases, social media posts and website posts through at least Feb. 1.&nbsp;
Read Next: <a href="https://www.benzinga.com/etfs/emerging-market-etfs/25/01/43130930/trump-looking-at-10-tariff-on-china-starting-feb-1">Trump &#8216;Looking At&#8217; 10% Tariff On China Starting Feb. 1&nbsp;</a>
The pause also includes the CDC's Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention scientific publication on health information and recommendations.
Some medical experts are concerned that the lack of communication from key health agencies could put public health in jeopardy.&nbsp;
"Not a day goes by when CDC isn't tracking a potential threat to our health," Richard Besser, MD, former acting director of the CDC, told CNN.
"Right now they are letting us know about bird flu in cows, birds, and people … Cutting off communications from CDC puts our health at risk and prevents our doctors, nurses, and public health leaders in our communities from doing their jobs. I urge the administration to quickly lift the pause," Besser continued.
Bird Flu Update: The H5 bird flu is widespread in wild birds and is causing outbreaks in poultry and U.S. dairy cows with several recent human cases in U.S. dairy and poultry workers.
There have been 67 confirmed human cases of bird flu in the U.S. since 2024, including one death. The CDC<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html"> says it is</a> &#8220;watching the situation carefully and working with states to monitor people with animal exposures.&#8221;
The New York Times<a href="https://www.nytimes.com/2025/01/23/nyregion/long-island-duck-farm-bird-flu.html"> reported</a> on Thursday that an outbreak of H5NI avian flu hit the last remaining duck farm on Long Island and all 100,000 ducks on the farm must be killed.&nbsp;
Before President Donald Trump took office last week, the CDC issued a new <a href="https://www.benzinga.com/general/biotech/25/01/43046294/bird-flu-raising-red-flags-among-health-officials-cdc-urges-faster-testing">health advisory</a> recommending that hospitalized patients who have tested positive for influenza be tested for the bird flu <a href="https://www.benzinga.com/general/biotech/25/01/42854890/us-records-first-human-bird-flu-death-high-levels-of-respiratory-illnesses-vaccine-stocks-rally">virus within 24 hours.&nbsp;</a>
Vaccines: Last Friday Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) announced<a href="https://www.benzinga.com/general/biotech/25/01/43117087/bird-flu-update-first-commercial-case-in-georgia-moderna-receives-590-million-to-develop-vaccine"> it received</a> an additional $590 million award from the HHS to accelerate the development of its mRNA-based influenza vaccines, including bird flu.
Other pharmaceutical companies, including Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), have bird flu vaccine candidates currently in clinical trials and CureVac NV (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) started a phase I/II study on its bird flu vaccine candidate developed in collaboration with GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>).&nbsp;
Read Next:&nbsp;
<ul>
<li><a href="https://www.benzinga.com/news/large-cap/25/01/43106379/trump-reverses-bidens-ai-policies-on-day-1-what-it-means-for-tech-giants-nvidia-amd-alphabet">Trump Reverses Biden&#8217;s AI Policies On Day 1: What It Means For Tech Giants Nvidia, AMD, Alphabet&nbsp;</a></li>
</ul>
Photo via Shutterstock.

Government

Politics

Trump Administration Halts All Communications From The Centers For Disease Control As Bird Flu Spreads

Legal

Press Releases

Shareholders that lost money on GSK plc(GSK) should contact Levi & Korsinsky about pending Class Action - GSK

GSK Investors Have Opportunity to Lead GSK plc Securities Fraud Lawsuit

GSK plc. (GSK) Investors Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit

Contact The Gross Law Firm by April 7, 2025 Deadline to Join Class Action Against GSK plc(GSK)

DEADLINE ALERT for TIXT, MODV, GSK, MPWR: Law Offices of Howard G. Smith Reminds Investors of Opportunity to Lead Securities Fraud Class Actions

DEADLINE ALERT for MPWR, GSK, and ICLR: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

The Gross Law Firm Notifies GSK plc Investors of a Class Action Lawsuit and Upcoming Deadline – GSK

GSK plc Class Action: Levi & Korsinsky Reminds GSK Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of April 7, 2025 - GSK

Deadline Alert: GSK plc. (GSK) Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit

April 7, 2025 Deadline: Contact Levi & Korsinsky to Join Class Action Suit Against GSK

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