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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.

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ViiV Healthcare announced Wednesday the latest findings from its <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">EMBRACE phase 2b study</a>.
The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), kept viral levels suppressed in adults living with HIV who were already <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44280792/viiv-healthcares-investigational-broadly-neutralising-antibody-n6ls-successfully-maintains-viral-s" rel="noreferrer noopener">stable on treatment</a>.
These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).
Results from the EMBRACE study at the six-month primary endpoint showed:
<ul>
<li>96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group.</li>
</ul>
<ul>
<li>Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher when measured at month six, compared to none in the standard-of-care group.</li>
</ul>
<ul>
<li>VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration.</li>
</ul>
<ul>
<li>ViiV Healthcare will progress a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial.</li>
</ul>
The company also presented data from two phase 2a proof-of-concept studies of investigational antiretroviral therapies, VH4524184 <a href="https://www.benzinga.com/pressreleases/25/03/b44261960/viiv-healthcare-showcases-leadership-in-long-acting-injectables-innovation-at-croi-2025-with-data-" target="_blank" rel="noreferrer noopener">(VH184) and VH4011499 (VH499)</a>.
Also Read: 
<ul>
<li><a href="https://www.benzinga.com/general/biotech/24/07/39915897/pfizer-and-gsks-viiv-healthcares-two-drug-hiv-treatment-matches-gileads-three-drug-combo-in-major" target="_blank" rel="noreferrer noopener">Pfizer And GSK&#8217;s ViiV Healthcare&#8217;s Two-Drug HIV Treatment Matches Gilead&#8217;s Three-Drug Combo In Major Trial</a></li>
</ul>
VH184 demonstrated potency at all doses. After 10 days of monotherapy, the average decreases were -1.17, -2.15, and -2.31 log10 copies/mL for the 10mg, 50mg, and 300mg doses, respectively.
<ul>
<li>The maximum viral load decline (-2.69 log10) was observed in the 300mg dose. Additionally, no drug-resistance mutations were observed at the end of the study.</li>
<li>Long-acting formulations of VH184 in adults without HIV are being evaluated in an ongoing phase 1 study.</li>
</ul>
<ul>
<li>The trial of VH499 showed that all oral doses (25mg, 100mg, and 250mg) led to a decrease in HIV-1 viral load ranging from -2.2 log10 copies/mL in the 250mg arm to -1.8 log10 copies/mL in the 25mg and 100mg arms. VH499 was well tolerated, with all adverse events being mild to moderate in severity.</li>
<li>There were no adverse events leading to withdrawal, and no serious adverse events were reported</li>
<li>On day 11, one individual on the 25mg dose developed a single mutation associated with reduced susceptibility to capsid inhibitors.</li>
</ul>
ViiV Healthcare is majority owned by GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), with Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Shionogi as shareholders.
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Biotech

GSK, Pfizer's ViiV Healthcare Shows Strong HIV Viral Suppression In Latest Study

<ul>
<li>Results from the phase IIb study, EMBRACE, demonstrate that N6LS, a bNAb administered every four months, effectively maintained undetectable viral load when combined with cabotegravir long-acting (CAB LA)</li>
<li>Results add to the growing body of evidence that N6LS is a potent antiviral that can function as a component of a complete antiretroviral regimen</li>
<li>EMBRACE study to continue investigating a combination of N6LS dosed at six months with CAB LA</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company's EMBRACE phase IIb study.1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants.
These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S.

ViiV Healthcare Announces Findings From The Company's EMBRACE Phase IIb Study; N6LS Maintains Viral Suppression In Long-acting Treatment Of HIV

On Wednesday, Zymeworks Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZYME#NASDAQ">ZYME</a>) released fourth-quarter financial results. The company reported an earnings loss of 31 cents per share, missing the <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">consensus loss of 3 cents</a>.
Sales came at $31.03 million, missing the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $45.2 million</a>.
In its fourth-quarter earnings results, Zymeworks said it is increasing its development <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44151625/zymeworks-provides-corporate-update-and-reports-fourth-quarter-and-full-year-2024-financial-result" rel="noreferrer noopener">efforts on plans for ZW251</a>.
&#8220;Based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients, we have decided to reprioritize resources for the advancement of ZW251, for which an IND submission is now planned for mid-2025,&#8221; Zymeworks said in a statement.
&#8220;As a result, we have paused preparations for the commencement of Phase 1 studies of ZW220 at this time. However, we believe ZW220 remains a highly differentiated, IND-ready ADC with encouraging preclinical data and strong commercial rationale with partnership potential. We look forward to providing future updates on the development for ZW220,&#8221; the company added.
The company plans to initiate a Phase 1 trial for ZW251 this year.
&#8220;ZW251 provides a new therapeutic modality option targeting GPC3 for hepatocellular carcinoma and represents an emerging opportunity in oncology that has yet to be fully realized,&#8221; said Zymeworks Chief Scientific Officer Paul Moore. &#8220;With a potential best-in-class design and differentiated mechanism, we believe our pipeline presents meaningful opportunities for both strategic partnerships and value creation&#8230;&#8221;
In February, Zymeworks achieved a <a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/g43967501/zymeworks-announces-achievement-of-14-million-milestone-from-gsk-collaboration" rel="noreferrer noopener">$14 million cash research</a> milestone associated with a clinical milestone from GSK Plc.
In November 2024, the FDA granted accelerated approval to Zymeworks and Jazz Pharmaceuticals Plc partnered Ziihera (zanidatamab) for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42106981/fda-grants-u-s-approval-of-ziihera-zanidatamab-hrii-for-the-treatment-of-adults-with-previously-tr" rel="noreferrer noopener">biliary tract cancer</a>.
Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response of 14.9 months. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Price Action: ZYME stock is down 7.97% at $12.13 at the last check Thursday.
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Cancer-Focused Zymeworks' Q4 Earnings Miss Expectations, Reprioritize Resources To Focus On ZW251

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that Quebec has become the first province to publicly reimburse 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 commends the Quebec government for its decision to grant timely access to APRETUDE for at-risk individuals who could benefit from PrEP. APRETUDE is now listed under the Régie de L'assurance Maladie du Québec (RAMQ). With cases of HIV continuing to rise across Canada, including in Quebec where cases have increased 37 per cent between 2019 and 2022,2 this decision will have a meaningful impact on HIV prevention efforts in the province.
APRETUDE is the first and only long-acting injectable approved in Canada to help reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents aged 12 years and older, and weighing at least 35kg.1 Findings from two real-world evidence studies (OPERA and Trio Health cohorts) showed more than 99 per cent effectiveness of APRETUDE for PrEP in nearly 1,300 individuals.3,4&nbsp;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, providing more options for PrEP for Canadians.1

Global

ViiV Healthcare Announces That Quebec Has Become The First Province To Publicly Reimburse  APRETUDE For Pre-Exposure Prophylaxis To Reduce The Risk Of Sexually Acquired HIV-1 Infection In At-Risk Individuals Who Are HIV-1 Negative

The Institute for Clinical and Economic Review (ICER) released a report on Monday assessing the clinical effectiveness and value of GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) chronic obstructive pulmonary disease (COPD) treatments, Trelegy Ellipta and Breo Ellipta.
Under the Inflation Reduction Act, CMS is negotiating prices for select Medicare Part D drugs. In the current cycle, Trelegy Ellipta and Breo Ellipta are among the medications under review, alongside 15 other drugs slated for <a target="_blank" href="https://www.benzinga.com/25/01/43062779/popular-ozempic-wegovy-selected-for-next-round-of-medicare-drug-price-negotiations" rel="noreferrer noopener">pricing changes in 2027</a>.
The findings will be submitted to the Centers for Medicare &amp; Medicaid Services (CMS) as part of ongoing Medicare drug price negotiations.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44084214/gsk-twice-yearly-depemokimab-reduces-nasal-polyp-size-improves-symptoms-in-chronic-rhinosinusitis-goes-under-fda-review-for-two-indications" rel="noreferrer noopener">GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review</a>
ICER President and CEO Sarah K. Emond emphasized the significance of the report, highlighting that over 15 million Americans suffer from COPD.
Both inhalers provide the advantage of once-daily dosing, a key difference from their comparators, which typically require multiple inhalers used twice daily.
Observational <a target="_blank" href="https://icer.org/news-insights/press-releases/icer-publishes-special-report-on-copd-therapies-as-part-of-cms-public-comment-process-on-medicare-drug-price-negotiations/" rel="noreferrer noopener">data</a> suggest that patients are more likely to adhere to once-daily therapies, potentially reducing COPD exacerbations, although the certainty of this outcome remains moderate.
Patient feedback also indicated a preference for single-inhaler, once-daily treatments. No major differences in adverse effects were observed between these inhalers and their alternatives.
Trelegy Ellipta, a triple-therapy inhaler containing an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta-agonist (LABA), was found to offer comparable or incremental net health benefits compared to generic triple therapies that require multiple inhalers.
Breo Ellipta, a dual-therapy inhaler combining an ICS and LABA, was similarly found to provide comparable or incremental net health benefits when compared to generic ICS/LABA inhalers.
ICER's report also analyzed cost-effectiveness, framing pricing calculations based on comparator therapies, including low-cost, authorized, and discounted brand-name drugs.
The report provides estimated price thresholds that CMS should consider in negotiations, though the actual prices paid by CMS for comparator drugs remain undisclosed.
Price Action: GSK stock is up 2.55% at $38.92 at the last check Tuesday.
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Photo by HJBC via Shutterstock

GSK's Once-Daily Inhalers For Smoker's Lung Has Potential Benefits: Independent Organization Report

On Monday, the Food and Drug Administration (FDA) accepted for review GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) marketing application for <a href="https://www.benzinga.com/general/biotech/25/01/43010436/gsk-highlights-new-approvals-vaccine-momentum-at-jp-morgan-healthcare-conference" target="_blank" rel="noreferrer noopener">depemokimab in two indications</a>.
The company released topline data from the trials in October 2024.
The <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/" rel="noreferrer noopener">proposed</a> indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Also Read:<a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38939147/gsks-experimental-asthma-drug-reduces-severe-attacks-phase-3-trial-data-shows" rel="noreferrer noopener"> GSK&#8217;s Experimental Asthma Drug Reduces Severe Attacks, Phase 3 Trial Data Shows</a>
The Prescription Drug User Fee Act (PDUFA) date is Dec. 16, 2025.
On Saturday, GSK announced full results from the ANCHOR-1 and ANCHOR-2 phase 3 trials of depemokimab versus placebo (both with the standard of care [SOC]) in adults with CRSwNP.
ANCHOR-1 (N=271) and ANCHOR-2 (N=257) <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/depemokimab-delivers-clinically-meaningful-and-statistically-significant-improvements-for-patients-with-chronic-rhinosinusitis-with-nasal-polyps-crswnp/" rel="noreferrer noopener">met</a> their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction versus placebo.
Additionally, a pooled analysis of the two trials showed improvements (reductions) from baseline versus placebo measured by:
<ul>
<li>Nasal polyp score (NPS, 0-8) at 52 weeks.</li>
<li>Mean nasal obstruction scores.</li>
</ul>
The treatment benefits were observed by the first assessment and sustained to week 52.
In pooled analyses of the secondary endpoints from both studies, nominally significant improvements favoring depemokimab versus placebo were observed.
When considering intervention with surgery or disease-modulating medication alone, the results still trended in depemokimab's favor. Up to 88% (n=239) of depemokimab-treated patients did not have surgery or disease-modulating medication vs. 83% (n=213) in the placebo group.
Price Action: GSK stock is up 2.04% at $38.36 at the last check Monday.
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Image: Shutterstock

GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review

On Saturday, Amgen&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) and AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) announced full results from the Phase 3, registrational WAYPOINT trial evaluating the efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44066175/positive-results-from-tezspire-tezepelumab-ekko-phase-3-waypoint-trial-highlight-rapid-sustained-e" rel="noreferrer noopener">with nasal polyps (CRSwNP)</a>.
The company released topline <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41843534/astrazeneca-amgens-asthma-drug-aces-late-stage-study-in-patients-with-chronic-rhinosinusitis" rel="noreferrer noopener">data in November 2024</a>.
The data demonstrated that Tezspire&nbsp;(tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery, and systemic corticosteroid use in CRSwNP (nasal polyps) patients compared to placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41756467/upstream-bio-is-new-on-nasdaq-can-potentially-beat-astrazenecas-asthma-drug-on-effi" rel="noreferrer noopener">Upstream Bio Is New On NASDAQ, Can Potentially Beat AstraZeneca&#8217;s Asthma Drug On Efficacy, Analysts Say</a>
Treatment with Tezspire significantly reduced nasal polyp severity: the Nasal Polyp Score (NPS) was -2.065, and the nasal congestion score was -1.028 at week 52 compared to placebo.
Improvements in NPS were observed as early as week four and nasal congestion as early as week two (the first post-treatment assessments, respectively) and were sustained through week 52.1
Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.
Tezspire significantly reduced the need for nasal polyp surgery by 98% and systemic corticosteroid treatment by 88% compared to placebo.
In patients with CRSwNP, Tezspire had a safety profile consistent with its approved severe asthma indication.
Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus.
In May, Amgen&nbsp;and&nbsp;AstraZeneca announced the results of the Phase 2a COURSE trial of Tezspire&nbsp;for severe chronic <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38924821/amgenastrazeneca-say-asthma-drug-shows-activity-in-another-lung-disease-across-broad-patient-popu" rel="noreferrer noopener">obstructive pulmonary disease</a>.
The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant.
The proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.
Price Action: AMGN stock traded higher by 0.77% to $310.51 at the last check on Monday. AZN stock is up 0.10% to $76.29 at the last check Monday.
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Photo via Shutterstock

AMGN

Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis

<ul>
<li>If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing</li>
<li>Submissions based on data from positive SWIFT and ANCHOR trials</li>
<li>SWIFT-1 and -2 showed depemokimab reduced exacerbation and hospitalisation rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo</li>
<li>ANCHOR-1 and -2 showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo</li>
</ul>

The FDA Has Accepted For Review GSK's Biologics License Application For The Use Of Depemokimab In Two Indications, The Prescription Drug User Fee Act Date Is 16 December 2025

<ul>
<li>ANCHOR-1 and ANCHOR-2 phase III trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing versus placebo.</li>
<li>Results with depemokimab were observed early at first assessment and sustained over 52 weeks.</li>
</ul>

On Saturday, GSK Announced Full Results From ANCHOR-1 and ANCHOR-2 Phase 3 Trials Assessing The Efficacy And Safety Of Depemokimab Versus Placebo In Adults With Chronic Rhinosinusitis With Nasal Polyps

London-based consumer healthcare group Haleon Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>) stock is trading lower on Thursday.
Haleon, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) spun off, reported revenue of 11.23 billion pounds (US$14.19 billion) for 2024. That&#8217;s down marginally by 0.6%.
Organic revenue growth was 5.0% with +3.7% price and +1.3% volume/mix with +6.8% organic growth in the fourth quarter.
Adjusted operating profit for 2024 <a href="https://www.haleon.com/news/press-releases/corporate/2025/2024-full-year-results" target="_blank" rel="noreferrer noopener">stood</a> at 2.5 billion pounds, down 6.5% at constant currency.
<ul>
<li>Oral Health: Revenue increased by 5.6% to 3.3 billion, with organic revenue growth of 9.6%.</li>
<li>Vitamins, Minerals, and Supplements: 2024 revenues increased by 3.4% to 1.7 billion with organic growth of 7.6%, including 8.2% organic growth in Q4 2024.</li>
<li>Pain Relief: Revenue declined 3.3%, with broadly flat organic growth of 0.1%, resulting in 2.6 billion in revenue.</li>
<li>Respiratory Health: Revenue declined 3.4% to 1.7 billion, with organic revenue growth of 0.9% and (1.3)% in the fourth quarter.</li>
</ul>
2024 growth was muted compared to recent years. This reflects a combination of lapping strong cold and flu comparatives arising from significantly elevated Contac demand in China in Q1 2023 from the lifting of COVID-19-related restrictions and a softer cold and flu season in H2 2024, particularly in the US.
Digestive Health and Other revenue declined 7.2% to 2 billion.
Guidance: The company projects 2025 organic revenue to grow between 4% and 6%. Haleon expects organic revenue and operating profit growth to be weighted towards the second half of the year.
The company expects a foreign exchange translation headwind of approximately 1.0% and 2.5% to negatively impact net revenue and adjusted operating profit.
&#8220;We are well positioned to drive organic revenue growth within our medium-term guidance range, with strong organic profit growth in 2025,&#8221; CEO Brian McNamara said in a statement.
Over the medium term, Haleon expects annual organic revenue growth of 4-6%.
Price Action: HLN stock is down 4.12% at $9.78 during the premarket session at the last check Thursday.
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</ul>
Image: Shutterstock

Sensodyne Toothpaste Maker Haleon Expects Profit To Be Weighted Towards Second Half Of 2025

<a href="https://www.cdc.gov/bird-flu/spotlights/h5n1-response-02262025.html#:~:text=As%20of%20February%2024%2C%20CDC,backyard%20poultry%20flock%20(Wyoming).">https://www.cdc.gov/bird-flu/spotlights/h5n1-response-02262025.html#:~:text=As%20of%20February%2024%2C%20CDC,backyard%20poultry%20flock%20(Wyoming).</a>
&nbsp;
<h2>Situation Update</h2>
February 26, 2025 &ndash; CDC continues to respond to the public health challenge posed by a multistate outbreak of avian influenza A(H5N1) virus, or &quot;H5N1 bird flu,&quot; in dairy cows, poultry, and other animals in the United States. CDC is working in collaboration with the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), Administration for Strategic Preparedness and Response (ASPR), state public health and animal health officials, and other partners using a <a href="https://www.cdc.gov/one-health/about/index.html">One Health approach</a>.

CDC A(H5N1) Bird Flu Response Update February 26, 2025; Confirmed 3 Human Cases Of H5 Bird Flu In People Who Became Ill In 2025 - Website

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Economics

U.S. Agriculture Secretary Brooke Rollins Says USDA Will Invest Up To $1B In Strategy To Curb Avian Flu; USDA Is Not Yet Authorizing Use Of Bird Flu Vaccines For Chickens

GSK's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) short percent of float has fallen 3.41% since its last report. The company recently reported that it has 17.43 million shares sold short, which is 0.85% of all regular shares that are available for trading. Based on its trading volume, it would take traders 3.81 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>GSK Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1740411023_0_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for GSK has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing GSK's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, GSK's peer group average for short interest as a percentage of float is 4.07%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

Short Sellers

Short Ideas

Peering Into GSK's Recent Short Interest

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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Photo by HJBC via Shutterstock

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>
</ul>
Image: Shutterstock

Hedge Funds

iShares Dow Jones US Pharmaceuticals Index Fund

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.
Read Next:
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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>
</ul>
Image: Shutterstock

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

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.
Read Next:
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<li><a href="https://www.benzinga.com/25/02/43629227/nano-cap-lipella-pharmaceuticals-stock-jumps-on-positive-trial-data-in-patients-with-sore-mouth-membranes" target="_blank" rel="noreferrer noopener">Nano Cap Lipella Pharmaceuticals Stock Jumps On Positive Trial Data In Patients With Sore Mouth Membranes</a></li>
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Analyst Ratings

DVAX

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

Press Releases

GSK Investors Have Opportunity to Lead GSK plc Securities Fraud Lawsuit

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ROSEN, TOP RANKED INVESTOR COUNSEL, Encourages GSK plc Investors to Secure Counsel Before Important Deadline in Securities Class Action – GSK

GSK plc Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before April 7, 2025 to Discuss Your Rights - GSK

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

INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in GSK plc of Class Action Lawsuit and Upcoming Deadlines - GSK

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

GSK plc Sued for Securities Law Violations - Investors Should Contact The Gross Law Firm Before April 7, 2025 to Discuss Your Rights - GSK

Shareholders that lost money on GSK plc (GSK) Urged to Join Class Action – Contact Levi & Korsinsky to Learn More

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

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