GSK Option Alert: Aug 15 $41 Calls at the Ask: 10000 vs 155 OI; Earnings 4/30 Before Open [est] 

GSK Option Alert: Aug 15 $41 Calls at the Ask: 10000 @ $2.3 vs 155 OI; Earnings 4/30 Before Open [est] Ref=$40.305

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, antiviral, and vaccines, and has been growing its presence in oncology and immunology, as well. GSK uses joint ventures to gain additional scale in certain markets like HIV.

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GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) on Wednesday agreed to acquire Boston Pharmaceuticals&#8217; <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">lead asset, efimosfermin alfa</a>.
Under the agreement, GSK will pay up to $2 billion in total cash consideration. This includes $1.2 billion upfront, with the potential for additional success-based milestone payments totaling $800 million.
GSK will also be responsible for success-based milestone payments and tiered royalties for efimosfermin owed to Novartis Pharma AG.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/04/45100064/britains-gsk-asserts-it-is-well-positioned-to-mitigate-potential-tariffs-after-strong-q1-cancer-and-hiv-drug-sales" target="_blank" rel="noreferrer noopener">Britain&#8217;s GSK Asserts It Is &#8216;Well Positioned&#8217; To Mitigate Potential Tariffs After Q1 Drug Sales</a>
Efimosfermin is a phase 3-ready, investigational specialty medicine for treating and preventing the progression of steatotic liver disease (SLD).
Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD.
SLD affects approximately 5% of the global population with limited therapeutic options.
ALD affects about 26 million patients globally. Together with MASH, it is the leading cause of liver transplants in the U.S.
In November 2024, Boston Pharmaceuticals <a target="_blank" href="https://www.businesswire.com/news/home/20241115839453/en/Boston-Pharmaceuticals-to-Announce-Positive-Phase-2-Data-on-Efimosfermin-Alfa-BOS-580-in-F2F3-MASH-During-Late-Breaking-Oral-Presentation-at-AASLD-2024-The-Liver-Meeting" rel="noreferrer noopener">shared</a> results from a Phase 2 study evaluating efimosfermin alfa (formerly known as BOS-580) at the American Association for the Study of Liver Diseases The Liver Meeting.
Treatment with efimosfermin led to significant improvements in fibrosis ≥1 stage without worsening of MASH, and MASH resolution without worsening of fibrosis over 24 weeks.
<ul class="wp-block-list">
<li>Study participants treated with efimosfermin showed rapid and significant improvement in fibrosis biomarkers and reductions in non-invasive markers of liver injury and liver fat over the study period.</li>
<li>Participants with type 2 diabetes also had significant and clinically meaningful improvement in HbA1c values.</li>
</ul>
In the study, efimosfermin demonstrated a favorable tolerability profile.
<ul class="wp-block-list">
<li>Over 24 weeks of treatment, efimosfermin-treated study participants had low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions.</li>
</ul>
Price Action: GSK stock is up 1.98% at $37.07 during the premarket session at the last check on Wednesday.
Read Next:
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</ul>
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GSK To Buy Phase-3 Ready Liver Disease Drug For Up To $2 Billion

<ul>
<li>Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options</li>
<li>Phase II data show potential of efimosfermin to reverse liver fibrosis, demonstrated in metabolic dysfunction-associated steatohepatitis (a form of SLD)</li>
<li>Unique properties offer potential for efimosfermin to be a new standard-of-care</li>
<li>Significantly expands GSK's hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease, offering multiple development options and potential first launch in 2029</li>
</ul>

GSK To Expand Liver Disease Portfolio With $1.2B Acquisition Of Boston Pharmaceuticals' Efimosfermin, Targeting 2029 Launch

iTeos Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITOS#NASDAQ">ITOS</a>) reported topline results from an updated interim analysis of the GALAXIES Lung-201 <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45372515/iteos-reports-topline-interim-results-from-galaxies-lung-201-study-of-belrestotug-dostarlimab-in-f" rel="noreferrer noopener">Phase 2 study on Tuesday</a>.
The trial sponsored by GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) assessed the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced, or metastatic PD-L1 high non-small <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">cell lung cancer (NSCLC)</a>.
The GALAXIES Lung-201 data demonstrated clinically meaningful improvements in the trial&#8217;s objective response rate (ORR) endpoint.
Also Read: <a target="_blank" href="https://www.benzinga.com//node/45100064" rel="noreferrer noopener">Britain&#8217;s GSK Asserts It Is &#8216;Well Positioned&#8217; To Mitigate Potential Tariffs After Strong Q1 Cancer And HIV Drug Sales</a>
However, the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression-free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy.
An interim analysis of the GALAXIES H&amp;N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.
Based on these results, iTeos and GSK have decided to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial will end.
iTeos Therapeutics said it is taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value. iTeos has engaged TD Cowen to advise on this process. 
&#8220;Given current market conditions and our appreciation of the responsibility to our valued shareholders, we believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets. With a strong balance sheet and a commitment to disciplined execution, we are well-positioned to pursue opportunities that maximize shareholder value,&#8221;&nbsp;said Michel Detheux, president and CEO of iTeos.
In April, iTeos said its cash and investments position was $624.3 million as of March 31, 2025, which is expected to provide a cash <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g45053301/iteos-reports-first-quarter-2025-financial-results-and-provides-business-updates" rel="noreferrer noopener">runway into 2027</a>.
Price Action: ITOS stock is up 17.3% at $8.12 at the last check on Tuesday.
Read Next:
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</ul>
Photo by Aunt Spray via Shutterstock

Movers

ITOS

iTeos Stock Soars Despite Trial Setback On Liquidation Buzz And Solid Cash Pile

–&nbsp;GALAXIES Lung-201 did not meet established criteria for clinically meaningful improvements in progression free survival
–&nbsp;Based on totality of data, iTeos and GSK have agreed to terminate the belrestotug development program
–&nbsp;iTeos has initiated a targeted review of strategic alternatives to maximize shareholder value
WATERTOWN, Mass. and GOSSELIES, Belgium, May 13, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITOS#NASDAQ">ITOS</a>), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today reported topline results from an updated interim analysis of GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos' development partner GSK assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC).
The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial's primary endpoint of objective response rate (ORR), however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&amp;N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.
Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients. The Company is taking immediate steps to preserve capital and has initiated a targeted process to identify opportunities that preserve and maximize shareholder value. iTeos has engaged TD Cowen to advise on this process.&nbsp;

iTeos Reports Topline Interim Results From GALAXIES Lung-201 Study Of Belrestotug + Dostarlimab In First-Line, PD-L1 High Non-Small Cell Lung Cancer Patients; Did Not Meet Established Criteria For Clinically Meaningful Improvements In Progression Free Survival; Based On Totality Of Data, ITeos And GSK Have Agreed To Terminate The Belrestotug Development Program

GLISTEN met the primary endpoint of change from baseline in monthly itch score and showed linerixibat (n=119) significantly improved itch versus placebo (n=119) over 24-weeks, as measured on a 0-10 numerical rating scale (NRS) for the worst itch (WI-NRS) (least squares [LS] mean difference [95% CI]: -0.72 [-1.15, -0.28], p=0.001). Monthly itch score evaluated the worst weekly itch of each month over the 24-week treatment period. This finding supports linerixibat's potential to address a major symptom of PBC, relentless itch.
&nbsp;
The trial also met key secondary endpoints including itch score at week 2 and itch-related sleep interference NRS over 24 weeks demonstrating:
·&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;Improvement in itch was rapid with a significant improvement over placebo at week 2 (LS mean difference [95% CI]: -0.71 [-1.07, -0.34], p&lt;0.001) and sustained throughout the trial.
·&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;Significant improvement in itch-related sleep interference, which impacts patient quality of life, over 24 weeks of treatment with linerixibat compared with placebo (LS mean difference [95% CI]: -0.53 [-0.98, -0.07], p=0.024).
·&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;More patients in the linerixibat group had clinically meaningful itch improvement (WI-NRS ≥3-point reduction) with 56% versus 43% in the placebo group at week 24 (treatment difference 13% [95% CI 0%-27%], nominal p=0.043).
&nbsp;
Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology &amp; Inflammation R&amp;D, GSK, said: "Relentless itch is present in the majority of patients with PBC and is a symptom that affects sleep, mental health, and quality of life. With linerixibat, we are one step closer to addressing the high unmet need of itch and its related sleep interference that are critically important to patients but historically under-treated."
&nbsp;
The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition, with gastrointestinal side-effects more common in the active treatment group. The most common adverse event, diarrhoea, was mostly mild in intensity; discontinuation due to diarrhoea was 4% in the linerixibat group versus &lt;1% in the placebo group.
&nbsp;
Gideon Hirschfield, Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Director of the Autoimmune and Rare Liver Disease Programme at University Health Network, Toronto and lead author of the GLISTEN study, said: "Currently there are very limited therapies for pruritus in PBC and previous attempts to develop new therapies have been unsuccessful. As an investigator who also sees many patients with PBC, and who has worked with this molecule from the early phase II studies, the clear improvements in itch and its related sleep interference seen in GLISTEN are meaningful and clinically important."
&nbsp;
Linerixibat is currently not approved anywhere in the world.

GSK Announced Results From GLISTEN Phase 3 Trial Of Linerixibat In Adults With Cholestatic Pruritus And PBC, A Rare Autoimmune Liver Disease. The Full Data Were Presented In A Late-breaker Oral Presentation At The EASL Congress 2025

On Wednesday, British multinational pharmaceutical GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) reported first-quarter sales of $9.46 billion (7.52 billion Sterling Pounds), up 2% year-over-year and 4% on constant currency. Analysts had <a href="https://www.benzinga.com/calendars/earnings" target="_blank" rel="noreferrer noopener">estimated sales of $7.46 billion</a>.
Vaccine sales fell 8% (-6% at constant currency) to 2.09 billion pounds, primarily impacted by lower demand for Arexvy related to a more limited ACIP recommendation and lower demand for Shingrix in the U.S. and International. Meningitis vaccines continued to show strong demand with double-digit sales growth.
Arexvy sales reached 78&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44876132/us-advisory-panel-votes-to-expand-recommendation-for-pfizer-gsks-rsv-vaccines-for-older-adults-below-60-years" rel="noreferrer noopener">million pounds, down 57%</a>. Meningitis vaccine <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-makes-strong-start-to-2025-with-growth-in-sales-profits-and-earnings/" rel="noreferrer noopener">sales</a> increased 17% (+20%) to 350 million, while established vaccine sales of 799 million fell 5% (-3%).
<a target="_blank" href="https://www.benzinga.com/25/04/44634572/gsk-stock-is-trading-higher-as-new-study-shows-shingles-vaccine-linked-to-20-lower-dementia-risk" rel="noreferrer noopener">Shingrix sales</a> reached 867 million pounds, down 8% (-7% at constant currency).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44496482/fda-approves-gsks-oral-antibiotic-for-urinary-tract-infections-for-females-aged-12-years-and-older" rel="noreferrer noopener">FDA Approves GSK&#8217;s Oral Antibiotic For Urinary Tract Infections For Females Aged 12 Years And Older</a>
Specialty Medicines sales grew by double-digit percentages (+16% and 17% on constant currency) in the quarter to 2.93 billion pounds, reflecting continued growth across disease areas, with strong performances in HIV, Respiratory, Immunology and Inflammation, and oncology.
General Medicines sales fell by 3% to&nbsp;2.49 billion pounds.
The company reported a core EPS of $1.13 (44.9 pence), beating the consensus of $1.04.
GSK plans to market five new specialty medicines this year, including the return of the previously withdrawn multiple <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44873982/uk-becomes-first-country-to-authorize-blenrep-in-two-combo-regimens" rel="noreferrer noopener">myeloma treatment Blenrep</a>.
Tariffs: GSK notes that the U.S. Administration has initiated an investigation under Section 232 of the Trade Expansion Act to determine the effects of <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">pharmaceutical product imports</a> on national security.
The company is well positioned to respond to the potential financial impact of sector-specific tariffs, should they be implemented, with mitigation options identified in the supply chain and productivity initiatives.
Guidance:&nbsp;GSK reaffirms 2025 guidance and expects sales to grow between 3% and 5%, with core earnings per share and operating profit growing between 6% and 8%.
Specialty Medicine sales are expected to increase by a low double-digit percent, Vaccine revenue is expected to decline by a low single-digit percent, and general medicine sales are expected to be broadly stable.
Price Action:&nbsp;At last check on Wednesday, GSK stock was up 3.57% to $40.37 during the premarket session.
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Photo by HJBC via Shutterstock

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Britain's GSK Asserts It Is 'Well Positioned' To Mitigate Potential Tariffs After Strong Q1 Cancer And HIV Drug Sales

WIIM

GSK shares are trading higher after the company reported better-than-expected Q1 financial results and raised its FY25 adjusted EPS guidance. Also, the company raised its FY25 sales guidance above estimates.

GSK (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) raises FY2025 Adj EPS guidance from $4.18-$4.26 to $4.25-$4.59 vs $4.36 analyst estimate. Raises FY2025 sales outlook from $40.07 billion-$40.85 billion to $40.68 billion-$42.71 billion vs $32.61 billion estimate.

GSK Raises FY2025 Adj EPS Guidance from $4.18-$4.26 to $4.25-$4.59 vs $4.36 Est; Raises FY2025 Sales Guidance from $40.07B-$40.85B to $40.68B-$42.71B vs $32.61B Est

The Core earnings per share guidance includes the implementation of the £2 billion share buyback program to the end of Q2 2026.
The Group has made planning assumptions that we expect turnover for Specialty Medicines to increase by a low double-digit per cent, Vaccines to decrease by a low-single digit per cent, and General Medicines to be broadly stable.

GSK Affirms Its FY25 Guidance And Expects Its Turnover To Increase Between 3%-5% And Core Operating Profit To Increase Between 6%-8%. Core EPS Is Expected To Increase Between 6%-8%

GSK (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) reported quarterly earnings of $1.13 per share which beat the analyst consensus estimate of $1.04 by 8.65 percent. This is a 3.39 percent increase over earnings of $1.09 per share from the same period last year. The company reported quarterly sales of $9.46 billion which beat the analyst consensus estimate of $7.46 billion by 26.82 percent. This is a 1.32 percent increase over sales of $9.34 billion the same period last year.

Earnings Beats

GSK Q1 Adj. EPS $1.13 Beats $1.04 Estimate, Sales $9.46B Beat $7.46B Estimate

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Earnings Scheduled For April 30, 2025

On Wednesday, the Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">respiratory tract disease (LRTD)</a>.
In June 2024, ACIP postponed a vote on a recommendation for adults aged 50-59 at increased risk for RSV-LRTD until additional <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39522040/cdc-advisor-panel-recommends-rsv-shots-in-us-for-people-above-75-years-analyst-says-decision-nega" rel="noreferrer noopener">data becomes available</a>.
The update includes Pfizer Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Abrysvo (Respiratory Syncytial Virus Vaccine), which the U.S. Food and Drug Administration approved in October 2024 for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41493556/fda-approves-pfizers-respiratory-syncytial-virus-vaccine-abrysvo-for-adults-below-60-years" rel="noreferrer noopener">risk of severe disease</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/government/regulations/25/04/44851905/trumps-new-order-targets-drug-pricing-transparency-and-medicare-cost-reduction" rel="noreferrer noopener">Trump&#8217;s New Order Targets Drug Pricing Transparency And Medicare Cost Reduction</a>
The recommendation also includes GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Arexvy in adults aged 50-59 who are at increased risk <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44853850/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-" rel="noreferrer noopener">for severe RSV disease</a>.
This expands on ACIP&#8217;s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older.
Arexvy is indicated for the prevention of LRTD caused by RSV in individuals 60 years of age and older and individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
According to the CDC, between 15,000 &#8211; 20,000 RSV-associated hospitalizations occur annually in U.S. adults <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44852139/acip-votes-to-expand-recommendation-for-pfizers-rsv-vaccine-abrysvo-to-include-adults-aged-50-to-5" rel="noreferrer noopener">aged 50 &#8211; 59 years</a>.
A systematic review of studies in the U.S. shows that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old.
GSK said the ACIP considered results from a phase 3 trial evaluating the immune response and safety of GSK&#8217;s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK&#8217;s RSV vaccine.
The updated recommendation does not benefit Moderna Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mRNA-based RSV vaccine mRESVIA (mRNA-1345), which is currently approved for adults over 60 years.
William Blair notes Moderna shared Phase 3 data for mRNA-1345 in high-risk adults aged 18-59 at its 2024 R&amp;D Day event and has since submitted an application to the FDA for regulatory approval using a priority review voucher.&nbsp;The FDA <a target="_blank" href="https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" rel="noreferrer noopener">has</a> accepted Moderna&#8217;s application and has assigned a PDUFA goal date of June 12, 2025.
Analyst Myles R. Minter highlights the Phase 3 trial of mRNA-1345 in over 1,000 high-risk individuals between ages 18 and 59. mRNA-1345 demonstrated non-inferior immunogenicity compared to adults age 60 or older for neutralizing antibodies against both RSV-A and RSV-B and a tolerable safety profile.
&#8220;If approved on time, we believe mRESVIA could be added to the updated age group recommendation during the scheduled June 25-26, 2025, ACIP meeting,&#8221; Minter said.
Price Action: PFE stock is up 1.07% 22.28, MRNA stock is down 2.30% at $24.62, and GSK stock is up 1.74% at $35.98 at the last check on Thursday.
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<li><a href="https://www.benzinga.com/25/04/44860903/eli-lillys-oral-glp-1-drug-orforglipron-hits-phase-3-goals-in-diabetes-trial-stock-shoots-higher" target="_blank" rel="noreferrer noopener">Eli Lilly&#8217;s Oral GLP-1 Drug Orforglipron Hits Phase 3 Goals In Diabetes Trial, Stock Soars</a></li>
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Photo by pedro7merino via Shutterstock

MRNA

US Advisory Panel Votes To Expand Recommendation For Pfizer, GSK's RSV Vaccines For Older Adults Below 60 Years

The U.K.&#8217;s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday authorized GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Blenrep.
Blenrep&nbsp;is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.&nbsp;
This&nbsp;U.K.&nbsp;regulatory authorization <a target="_blank" href="https://otp.tools.investis.com/generic/regulatory-story.aspx?cid=410&amp;newsid=1931677" rel="noreferrer noopener">marks</a> the first in the world for&nbsp;Blenrep&nbsp;in this treatment setting.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44496482/fda-approves-gsks-oral-antibiotic-for-urinary-tract-infections-for-females-aged-12-years-and-older" rel="noreferrer noopener">FDA Approves GSK&#8217;s Oral Antibiotic For Urinary Tract Infections For Females Aged 12 Years And Older</a>
Efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma support MHRA authorization of&nbsp;Blenrep&nbsp;combinations.
These include statistically significant and clinically meaningful progression-free survival (PFS) results for&nbsp;Blenrep&nbsp;combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.
DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.
In DREAMM-7, the&nbsp;Blenrep&nbsp;combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively.
<ul>
<li>DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months, favoring the Blenrep combination (n=243) versus the daratumumab-based <a href="https://www.benzinga.com/general/biotech/24/12/42420807/gsks-blood-cancer-drug-shows-improved-survival-compared-to-johnson-johnsons-darzalex" target="_blank" rel="noreferrer noopener">comparator (n=251)</a>.</li>
<li>The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. </li>
</ul>
In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the&nbsp;Blenrep&nbsp;combination compared to 12.7 months in the bortezomib combination.
Blenrep&nbsp;combinations are currently under review in 14 countries, including the&nbsp;U.S., with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025.
In 2022,&nbsp;GSK withdrew&nbsp;the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial,&nbsp;which did not meet the requirements of the FDA&nbsp;<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">Accelerated Approval regulations</a>.&nbsp;
Price Action: GSK stock is up 1.74% at $35.99 at the last check Thursday.
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Photo by HJBC via Shutterstock

UK Becomes First Country To Authorize Blenrep In Two Combo Regimens

<ul>
<li>Building on the last approval of Jemperli offering PFS benefit in dMMR/MSI-HC endometrial cancer, the expanded indication now offers survival benefit across the overall study population (dMMR/MSI-H and MMRp/MSS tumours)</li>
<li>Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone</li>
</ul>
MISSISSAUGA, ON, April 17, 2025 /CNW/ - GSK today announced that Health Canada has approved Jemperli (dostarlimab for injection) in combination with chemotherapy (carboplatin and paclitaxel) for the treatment of adult patients with primary advanced or first recurrent endometrial cancer who are candidates for systemic therapy.[1]&nbsp;This approval broadens the previous indication for Jemperli in combination with carboplatin and paclitaxel to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which represents approximately 75% [2]&nbsp;of patients diagnosed with endometrial cancer and who have limited treatment options.

Global

GSK Announces Health Canada Expands Jemperli Plus Chemotherapy Approval To All Adult Patients With Primary Advanced Or First Recurrent Endometrial Cancer, As The First And Only Immuno-Oncology-Based Treatment To Show An Overall Survival Benefit For These Patients

GSK Plc Reveals That  CDC Advisory Panel Recommends PENMENVY for Inclusion in Adolescent Meningococcal Vaccination Schedule

Analyst Ratings

Watching GSK; Shares Move Higher, Goldman Sachs Suggesting Arexvy To Be Expanded By CDC; "Our Read Of The Slides Suggests The ACIP Voting To Expand Its Recommended Population For Arexvy To Those Aged 50-59 'At-Risk' Is Likely"

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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</ul>
Photo by MargJohnsonVA via Shutterstock

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Government

ARGX

GILD

REGN

RHHBY

UCBJF

UCBJY

Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments&nbsp;across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization.

Contracts

ABL Bio Announced A Worldwide Licensing Agreement With GSK To Develop Medicines For Neurodegenerative Diseases By Utilizing ABL Bio's Blood-brain Barrier Shuttle Platform, Grabody-B, ABL Bio Will Receive Up To £2.075B Including £77.1M In Upfront And Near-term Payments

In the current session, GSK Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) is trading at $37.71, after a 3.33% decrease. Over the past month, the stock fell by 8.79%, and in the past year, by 10.58%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. 

<img src="https://www.benzinga.com/files/images/story/2025/1743800417_0.png" alt="Past Year Chart" />

<h3>GSK P/E Ratio Analysis in Relation to Industry Peers</h3>
The P/E ratio measures the current share price to the company's EPS. It is used by long-term investors to analyze the company's current performance against it's past earnings, historical data and aggregate market data for the industry or the indices, such as S&amp;P 500. A higher P/E indicates that investors expect the company to perform better in the future, and the stock is probably overvalued, but not necessarily. It also could indicate that investors are willing to pay a higher share price currently, because they expect the company to perform better in the upcoming quarters. This leads investors to also remain optimistic about rising dividends in the future. 
Compared to the aggregate P/E ratio of the 28.33 in the Pharmaceuticals industry, GSK Inc. has a lower P/E ratio of 24.27. Shareholders might be inclined to think that the stock might perform worse than it's industry peers. It's also possible that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2025/1743800417_1.png" alt="Guage" />

In conclusion, the price-to-earnings ratio is a useful metric for analyzing a company's market performance, but it has its limitations. While a lower P/E can indicate that a company is undervalued, it can also suggest that shareholders do not expect future growth. Additionally, the P/E ratio should not be used in isolation, as other factors such as industry trends and business cycles can also impact a company's stock price. Therefore, investors should use the P/E ratio in conjunction with other financial metrics and qualitative analysis to make informed investment decisions.

Intraday Update

Markets

A Look Into GSK Inc's Price Over Earnings

Researchers investigated whether the shingles (herpes zoster) vaccine can help prevent dementia. Previous studies suggest that certain herpes viruses may contribute to dementia, and vaccines might have <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">immune benefits</a>.
The new research, published on Wednesday, Nature analyzed data from 282,541 older adults in Wales and found that people who received the original shingles live virus vaccine were 20% less likely to develop dementia than non-vaccinated participants.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44395415/trump-administration-weighs-deep-cuts-to-domestic-hiv-prevention-programs-gilead-stock-slides" rel="noreferrer noopener">Trump Administration Weighs Deep Cuts To Domestic HIV Prevention Programs, Gilead Stock Slides</a>
Shingles, also known as herpes zoster, is&nbsp;a painful rash illness caused by the varicella-zoster virus, the same virus that causes chickenpox, which reactivates in the body after a person has had chickenpox.
The <a target="_blank" href="https://www.nature.com/articles/s41586-025-08800-x#Sec4" rel="noreferrer noopener">study</a> found that getting the zoster vaccine lowered the chance of being diagnosed with dementia over seven years by 3.5 percentage points, or about 20% relative risk reduction.
The protective effect was stronger in women than men. The findings were confirmed in another population (England and Wales) using death certificate data, showing fewer dementia-related deaths among vaccinated individuals.
Previous research in July 2024 <a target="_blank" href="https://www.nature.com/articles/s41591-024-03201-5" rel="noreferrer noopener">hinted</a> that the older live shingles vaccine might offer some protection, but that vaccine has been discontinued in favor of the recombinant version.
Researchers found that people who received the recombinant vaccine had a 17% longer period without a dementia diagnosis—equal to about 164 extra days dementia-free for those who eventually developed the condition.
The recombinant vaccine also appeared to reduce dementia risk more than flu and tetanus–diphtheria–pertussis vaccines. The effect was seen in both men and women but was stronger in women.
Last year, GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) revealed data from the ZOSTER-049 long-term follow-up phase 3 trial, which followed participants for up to approximately 11 years following initial vaccination with Shingrix <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38289827/gsk-says-its-blockbuster-shingles-vaccine-shows-high-efficacy-even-after-10-years" rel="noreferrer noopener">(Recombinant Zoster Vaccine or RZV)</a>.&nbsp;
The final trial data demonstrate that RZV has maintained efficacy against shingles in adults over 50 for over a decade.&nbsp;
Shingrix sales for 2024 reached 3.36 billion pounds, down 2% (+1% at <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">constant currency)</a>.
Price Action: GSK stock is up 3.71% at $39.04 at the last check Thursday.
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<li><a href="https://www.benzinga.com/25/04/44613813/sm-energy-to-see-q1-oil-output-rise-amid-uinta-expansion-says-analyst" target="_blank" rel="noreferrer noopener">SM Energy&#8217;s Near-Term Focus Centers On Debt Reduction Over Stock Buybacks: Analyst</a></li>
</ul>
Photo by HJBC via Shutterstock

New Study Shows Shingles Vaccine Linked To 20% Lower Dementia Risk, GSK Stock Pops

Legal

Press Releases

Investors in GSK plc Should Contact Levi & Korsinsky Before April 7, 2025 to Discuss Your Rights – GSK

GSK plc Investors: Please contact the Portnoy Law Firm to recover your losses. April 7, 2025 Deadline to file Lead Plaintiff Motion.

Barbara Weber, M.D., Elected to ITM Supervisory Board

GSK Awards $2M in Grant Funding for Programs Supporting Adult Vaccination, Commits Additional $2M for 2025

Investing in the $532B Oncology Boom: Key Stocks Shaping the Future of Cancer Treatment

GSK's 5-in-1 Meningococcal Vaccine PENMENVY Receives Positive Recommendation from US Advisory Committee on Immunization Practices

AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices

Alector Announces Completion of Enrollment in the PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Individuals with Early Alzheimer's Disease

GSK and Lifetime® launch original movie to raise awareness about the impact of meningitis

GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)

ADCT

ALEC

BNTX

DAWN

OSTX

RLAY

RVMD

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Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

Axsome Therapeutics

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

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Elanco Animal Health

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

Haleon

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Organon

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

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Dr Reddy's Laboratories

Regencell Bioscience Holdings Limited - Ordinary Shares

Regencell Bioscience

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