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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, 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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Sagimet Biosciences Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMT#NASDAQ">SGMT</a>) said on Wednesday that denifanstat met all primary and secondary endpoints in a Phase 3 trial for moderate to <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">severe acne vulgaris</a>.
The trial was conducted by Sagimet&#8217;s license partner, Ascletis Bioscience Co. Ltd., <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45765051/sagimet-biosciences-announces-positive-phase-3-results-for-denifanstat-for-the-treatment-of-modera" rel="noreferrer noopener">in China</a>.
Denifanstat is a once-daily oral small-molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for metabolic dysfunction-associated steatohepatitis&nbsp;(MASH) in the rest of the world.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44515808/nano-cap-dermata-therapeutics-unveils-positive-data-from-once-weekly-drug-study-for-acne">Nano-Cap Dermata Therapeutics Unveils Positive Data From Once Weekly Drug Study For Acne</a>
Additionally, Sagimet recently initiated a Phase 1 first-in-human trial with a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S.
The trial randomized 480 patients in China to receive either denifanstat once daily or a placebo for 12 weeks.
For the primary endpoint of treatment success, defined as an Investigator&#8217;s Global Assessment score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline at week 12, the denifanstat group demonstrated a statistically significant 33.2% rate over the placebo group&#8217;s 14.6%.
Additional goals further corroborated denifanstat&#8217;s efficacy versus placebo, including:
<ul class="wp-block-list">
<li>Reduction in total lesion count (57.4% vs 35.4%).</li>
<li>Reduction in inflammatory lesion count (63.5% vs 43.2%).</li>
<li>Reduction in non-inflammatory lesion count (51.9% vs. 28.9%).</li>
</ul>
Ascletis reported that denifanstat was generally well-tolerated. Following 12 weeks of once-daily oral administration at 50 mg, treatment-emergent adverse events (TEAE) incidence rates were comparable between denifanstat and placebo.
All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs. No deaths were reported.
These Phase 3 results confirm that FASN inhibition represents a potential therapeutic approach within acne. Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration.
Building on Ascletis&#8217; Phase 3 results, Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S.
In other notable pharmaceutical industry news, GSK plc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) agreed to acquire&nbsp;Boston Pharmaceuticals&#8217;&nbsp;lead asset, efimosfermin alfa, a phase 3-ready, investigational specialty medicine for treating and preventing the progression of <a href="https://www.benzinga.com/general/biotech/25/05/45406673/gsk-to-buy-phase-3-ready-liver-disease-drug-for-up-to-2-billion" target="_blank" rel="noreferrer noopener">steatotic liver disease</a> in May.
Under the agreement, GSK will pay up to $2 billion in total cash consideration, including $1.2 billion upfront, with the potential for additional success-based milestone payments totaling $800 million.
This highlights ongoing investment in the liver disease space, an area where Sagimet is also active with its MASH program.
Price Action: SGMT stock is trading higher by 31.7% to $4.78 premarket at last check Wednesday.
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Sagimet's Partner Achieves Positive Results With Oral Acne Drug In Phase 3 Trial In China, Stock Jumps

Lyra Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LYRA#NASDAQ">LYRA</a>) released results on Monday from the ENLIGHTEN 2 Phase 3 trial of LYR-210 in adult patients with <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">Chronic Rhinosinusitis (CRS)</a>.
The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (p=0.0078) in patients without nasal polyps.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44083934/amgen-astrazeneca-partnered-asthma-drug-shows-rapid-and-sustained-effect-in-chronic-rhinosinusitis" rel="noreferrer noopener">Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis</a>
The ENLIGHTEN 2 trial also met the key secondary endpoints of 3CS at 24 weeks in the full population (i.e., patients with and without nasal polyps) and in the clinically validated SNOT-22 score at 24 weeks, with symptom improvement <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45717754/lyra-therapeutics-reports-positive-results-from-the-enlighten-2-phase-3-trial-of-lyr-210-achieving" rel="noreferrer noopener">observed as early as week 4</a>.
<ul class="wp-block-list">
<li>Improvements in SNOT-22 were sustained throughout the trial and were clinically meaningful. More than twice the minimal clinically important difference was observed at week 24 compared to baseline in the LYR-210 group (-22.4 points).</li>
</ul>
Consistent with previous studies, LYR-210 was well-tolerated, with a safety profile similar to sham control.
Data evaluating computed tomography (CT) scans demonstrated numerical improvement in ethmoid sinus opacification in patients who received LYR-210, compared to sham control at week 20 (-2.15; p=0.1809). These data provide objective radiological evidence of improvement with LYR-210 treatment.
<ul class="wp-block-list">
<li>LYR-210 patients showed no difference from sham patients in using corticosteroid rescue medication; however, the LYR-210 patients had fewer endoscopic sinus surgeries than sham control.</li>
</ul>
LYR-210 was well tolerated, with no product-related serious adverse events in the ENLIGHTEN 2 trial.
The ENLIGHTEN program consists of two Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for CRS.
<ul class="wp-block-list">
<li>While the ENLIGHTEN 2 trial met its primary endpoint and key secondary endpoints, the ENLIGHTEN 1 trial did not meet the primary or secondary endpoints, as&nbsp;<a href="https://www.benzinga.com/news/24/05/38642703/why-lyra-therapeutics-stock-is-down-93-today" target="_blank" rel="noreferrer noopener">reported&nbsp;in May 2024</a>.</li>
</ul>
Lyra also conducted a pooled data analysis of 64 CRS patients with small nasal polyps (grade 1) from the ENLIGHTEN 1 and ENLIGHTEN 2 trials. The data demonstrated a consistent positive trend compared to sham control over 24 weeks in multiple endpoints:
<ul class="wp-block-list">
<li>Improvement in 3CS with LYR-210 compared to sham control at week 24, starting as early as week 4.</li>
<li>Improvement in SNOT-22 score with LYR-210 compared to sham control at week 24, starting as early as week 4.</li>
<li>Improvements in percent ethmoid opacification with LYR-210 compared to sham control at week 20.</li>
<li>Improvements in nasal congestion score (NCS) with LYR-210 compared to sham control at week 24 for patients with moderate to severe NCS at baseline, starting as early as week 4.</li>
<li>Improved nasal polyp score with LYR-210 compared to sham control at week 24.</li>
</ul>
In March,&nbsp;the Food and Drug Administration (FDA) accepted for review&nbsp;GSK plc's&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) marketing application for&nbsp;<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">depemokimab in two indications</a>:
<ul class="wp-block-list">
<li>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</li>
<li>Add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).</li>
</ul>
Price Action: LYRA stock is up 411.6% at $25.22&nbsp;during the premarket session at the last check on Monday.
Read Next:
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<li><a href="https://www.benzinga.com/markets/biotech/25/05/45703024/pfizer-reports-survival-gains-in-colorectal-cancer-study-combo-therapy-cuts-death-risk-by-over-50" target="_blank" rel="noreferrer noopener">Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%</a></li>
</ul>
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LYRA

Why Is Lyra Therapeutics Stock Surging Over 400% On Monday?

<ul>
<li>Definitive agreement to result in one-time $225 million cash payment&nbsp;</li>
<li>Theravance Biopharma retains&nbsp;rights to up to $150 million in milestones from Royalty Pharma on Trelegy Ellipta net sales in 2025 and 2026, requiring minimal to no growth over 2024 actuals to be achieved</li>
<li>$225 million from royalty transaction announced today,&nbsp;in addition to the $1.1 billion upfront received in 2022, and up to $200 million in milestones (of which $50 million was received in 2025), brings total potential lifetime value from Trelegy Ellipta&nbsp;monetization efforts to $1.525 billion</li>
<li>First outcome from Strategic Review Committee's ongoing efforts to maximize shareholder value; Board remains&nbsp;committed to returning excess capital to shareholders</li>
</ul>

Theravance Biopharma Secures $225M In Cash From GSK Deal, Bringing Total Trelegy Monetization Value To $1.525B

Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Friday announced results from two Phase 3 trials of itepekimab in <a href="https://www.benzinga.com/general/health-care">chronic obstructive pulmonary disease (COPD) patients</a>.
Phase 3 AERIFY-1 trial evaluating itepekimab in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, <a href="https://www.benzinga.com/pressreleases/25/05/g45687030/itepekimab-met-primary-endpoint-in-one-of-two-chronic-obstructive-pulmonary-disease-copd-phase-3-t">a clinically meaningful benefit</a>.
A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint. Despite showing some benefit earlier in the trial (at week 24), itepekimab did not achieve a statistically significant reduction in moderate or severe exacerbations at week 52 in the second trial.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44121869/gsks-once-daily-inhalers-for-smokers-lung-has-potential-benefits-independent-organization-report" target="_blank" rel="noreferrer noopener">GSK&#8217;s Once-Daily Inhalers For Smoker&#8217;s Lung Has Potential Benefits: Independent Organization Report</a>
In the trials, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy.
The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment.
The total number of exacerbations was lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the global COVID-19 pandemic, which could have contributed to the lower overall exacerbation rates.
The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups.
Regeneron and Sanofi will review the data and discuss it with regulatory authorities to evaluate the next steps.
Itepekimab is also being evaluated in other respiratory conditions, including chronic rhinosinusitis without nasal polyps, chronic rhinosinusitis with nasal polyps, and non-cystic fibrosis bronchiectasis.
In November 2024, Regeneron and Sanofi&#8217;s Dupixent gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41945225/regeneron-sanofis-dupixent-approval-signals-major-treatment-breakthrough-for-smokers-lung-disease" rel="noreferrer noopener">seven years ago</a>.
This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.
Last Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and <a href="https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-us-fda/">an</a> eosinophilic phenotype.
Last June, the FDA approved&nbsp;Verona Pharma plc's&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRNA#NASDAQ">VRNA</a>) Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD)&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39526177/first-inhaled-copd-therapy-in-over-2-decades-fda-approves-verona-pharmas-first-commercial-product" rel="noreferrer noopener">in adult patients</a>.
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
In May, Sanofi announced it will invest at least $20 billion in the U.S. <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">through 2030</a>. Research and development, plus U.S. manufacturing, will receive the <a href="https://www.benzinga.com/25/05/45419235/sanofi-joins-other-big-pharma-to-navigate-potential-tariff-impact-with-at-least-20-billion-in-investments-through-2030" target="_blank" rel="noreferrer noopener">bulk of the spending</a>.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help&nbsp;enhance the U.S. supply chain.
Earlier in May, Regeneron secured the winning bid in the bankruptcy auction for key assets of&nbsp;23andMe Holding Co.&nbsp;in a&nbsp;$256 million deal&nbsp;to boost its genetics-based <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45504107/genetic-data-from-23andme-ends-up-with-this-company-in-256-million-deal" rel="noreferrer noopener">drug discovery efforts</a>.
Price Action: REGN stock is down 9.98% at $545, and SNY stock is down 4.57% at $49.96 during the premarket session at last check Friday.
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<li><a href="https://www.benzinga.com/25/05/45487788/trumps-drug-price-order-hits-pbms-hardest-cvs-cigna-unh-in-focus-as-experts-highlight-racket-and-pricing-distortion">Trump&#8217;s Drug Price Order Hits PBMs Hardest: CVS, Cigna, UNH In Focus As Experts Highlight &#8216;Racket,&#8217; Pricing Distortion</a></li>
</ul>
Photo by Marianne Campolongo via Shutterstock

REGN

VRNA

Regeneron, Sanofi Stock Falls After Uneven Smoker's Lung Drug Data

GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Spero Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRO#NASDAQ">SPRO</a>) on Wednesday announced that the pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">early for efficacy</a>.&nbsp;
Spero&#8217;s stock price was up 245.89% at last check Wednesday following the news. 
The decision <a target="_blank" href="https://otp.tools.investis.com/generic/regulatory-story.aspx?cid=410&amp;newsid=1948433" rel="noreferrer noopener">follows</a> a recommendation from an Independent Data Monitoring Committee (IDMC) based on a planned interim analysis of data from 1,690 patients enrolled in the study.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45406673/gsk-to-buy-phase-3-ready-liver-disease-drug-for-up-to-2-billion" rel="noreferrer noopener">GSK To Buy Phase-3 Ready Liver Disease Drug For Up To $2 Billion</a>
If approved, tebipenem HBr would be the first oral carbapenem antibiotic&nbsp;for patients in the U.S. who suffer from cUTIs. It would add to&nbsp;GSK&#8217;s anti-infectives portfolio and help address the challenges of antimicrobial resistance (AMR).
The trial met the primary endpoint of non-inferiority&nbsp;of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis,&nbsp;on the overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.&nbsp;
The IDMC review did not identify any new safety concerns beyond those reported in other studies with tebipenem. Diarrhea and headache are the two most reported adverse events. 
GSK plans to work with U.S. regulatory authorities to include the data in a filing in 2025.
GSK&#8217;s Chief Scientific Officer Tony Wood said there are limited oral options for drug-resistant infections. This contributes to over $6 billion per year in US healthcare costs.
&nbsp;An estimated 2.9 million cases of cUTIs are treated annually in the U.S. alone. The current standard of care includes carbapenem antibiotics, especially in case of sepsis and allergies or resistance to other antibiotics, but they are only available for IV administration.
Federal funds from the&nbsp;U.S.&nbsp;Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA) support the development of tebipenem HBr.
It is GSK&#8217;s second anti-infective program to be stopped early for efficacy in Phase 3, following the EAGLE 2 and EAGLE 3 trials for gepotidacin in 2022.
In March, the US Food and Drug Administration (FDA) approved&nbsp;GSK&#8217;s Blujepa&nbsp;(gepotidacin) for female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary&nbsp;<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">tract infections (uUTIs)</a>.
In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics to develop and commercialize tebipenem HBr in all markets except <a target="_blank" href="https://www.benzinga.com/general/biotech/22/09/28960518/spero-therapeutics-stock-almost-doubles-on-gsk-pact-for-its-lead-antibiotic" rel="noreferrer noopener">certain Asian territories</a>.&nbsp;
Price Action: GSK is down 0.33%, trading at around $39.32 per share. 
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</ul>
Image: Shutterstock

SPRO

Why Is GSK Partner Spero Therapeutics Stock Skyrocketing On Wednesday?

Spero Therapeutics And GSK Announce The PIVOT-PO Phase 3 Study Of Tebipenem HBr Met Its Primary Endpoint And will Stop Early For Efficacy

GSK's Blenrep (Belantamab Mafodotin) Received Positive Opinion Form The EUs CHMP For Treatment Of Relapsed Or Refractory Multiple Myeloma In Adults Aged 60+

<a href="https://www.publicnow.com/view/ECB93D297256E9F44E80E966479BE2F0BC4A97AB/37161">https://www.publicnow.com/view/ECB93D297256E9F44E80E966479BE2F0BC4A97AB/37161</a>

GSK Announces Approval Of Nucala By US FDA For Use In Adults With Chronic Obstructive Pulmonary Disease

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.
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<li><a href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" target="_blank" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a></li>
</ul>
Image: Shutterstock

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.
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Photo by Aunt Spray via Shutterstock

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.
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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."
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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

Earnings

Guidance

Eurozone

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

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

Press Releases

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)

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD)

Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee

Small-Cap Movers Under $1: HIT, SPRO, SGN, PRSO, SGBX Drive Momentum Across AI, Biotech, Crypto, Software, Etc.

Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million

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