에 대한 최신 뉴스 GSK (NYSE:GSK) 주식

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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도널드 트럼프 대통령은 화요일(8일) 외국 의약품에 대한 &#34;주요 관세&#34; 계획을 공개했다.트럼프 대통령은 전국공화당의회위원회(NRCC) 만찬에서 이렇게 말했다. &#34;우리는 곧 의약품에 대한 주요 관세를 발표할 것이다...관세 소식을 들으면 회사들은 중국을 떠날 것이다...대부분 제품이 미국에서 판매되기 때문이다.&#34;

트럼프의 의약품 관세 계획...뱅크오브아메리카에서 제시한 타임라인은?

Toronto,,Ontario,,Canada,-,February,14,,2021,:,Gsk,Glaxosmithkline

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켄 그리핀의 헤지펀드 시타델(Citadel)이 GSK PLC(NYSE:GSK)에 3억 5,000만 파운드(3억 9,000만 달러)의 공매도 베팅을 걸었다. 이는 영국 제약 대기업 GSK에 대한 10년래 가장 큰 베팅이라고 파이낸셜타임스가 보도했다.

켄 그리핀의 헤지펀드 시타델, 제약사 GSK에 대규모 공매도 베팅

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네바다의 한 낙농업자가 1월에 루이지애나 남자의 사망과 관련된 조류 독감 D1.1 변종에 양성 반응을 보였다고 CNN이 보도했다. 미국 질병통제예방센터(CDC)는 월요일에 초기 양성 반응을 확인하기 위해 작업 중이다.

네바다 남성에서 발견된 치명적인 조류 독감 변종: 주목해야 할 4가지 주식

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

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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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SGMT

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.
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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>
Photo: Shutterstock

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>
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Photo by Marianne Campolongo via Shutterstock

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.
Read Next:
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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.
Read Next:
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<li><a href="https://www.benzinga.com/news/earnings/25/05/45376829/cyberark-stock-slips-despite-strong-q1-growth-in-subscriptions-and-raised-2025-outlook" target="_blank" rel="noreferrer noopener">CyberArk Stock Slips Despite Strong Q1 Growth In Subscriptions And Raised 2025 Outlook</a></li>
</ul>
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.
&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.
Read Next:
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</ul>
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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Photo by pedro7merino via Shutterstock

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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도널드 트럼프 대통령은 화요일(8일) <a href="https://www.benzinga.com/topic/tariffs" target="_blank" rel="noopener">외국 의약품</a>에 대한 "주요 관세" 계획을 공개했다.
트럼프 대통령은 <a href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" target="_blank" rel="noopener">전국공화당의회위원회(NRCC) 만찬</a>에서 이렇게 말했다. "우리는 곧 의약품에 대한 주요 관세를 발표할 것이다&#8230;관세 소식을 들으면 회사들은 중국을 떠날 것이다&#8230;대부분 제품이 미국에서 판매되기 때문이다.&#8221;
또한 트럼프는 에어포스원 기내에서 기자들에게 "제약" 관세가 "이전에는 실제로 보지 못했던 수준"에 도달할 것이라며 "가까운 장래에 발표될 것"이라고 말했다고 <a href="https://www.bbc.com/news/articles/cedyylj1v32o" target="_blank" rel="noopener">BBC는 덧붙였다.</a>
트럼프 대통령은 지난주 관세를 발표하면서 의약품을 새로운 관세 대상에서 제외했는데, 이는 <a href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" target="_blank" rel="noopener">의약품 수입</a>에 25% 관세를 부과하겠다는 이전 발언 이후 압박을 받던 업계에 안도감을 안겨준 것으로 보인다.
수요일(9일) 트럼프 대통령은 깜짝 발표를 통해 <a href="https://www.benzinga.com/topic/tariffs" target="_blank" rel="noopener">미국의 무역 조치</a>에 보복하지 않은 국가에 대해 90일 동안 관세를 유예한다고 발표했다. 이 소식은 광범위한 리스크온 랠리에 불을 붙였고, 주요 지수는 수개월 만에 최고치를 기록하고 변동성이 급락했다.
트럼프는 최근 트루스 소셜에 올린 글에서 중국이 "존중이 부족하다"고 비난하며 중국산 제품에 대한 즉각적인 125% 관세 인상을 선언했다.
그는 "가까운 시일 내에 중국이 미국과 다른 국가를 상대로 폭리를 취하는 것이 더 이상 지속 가능하지도, 용납될 수도 없다는 것을 깨닫게 되기를 바란다"고 말했다. 그리고 "나의 강력한 제안에도 불구하고 어떤 방식, 형태, 형태로든 보복을 하지 않은" 75개 이상의 국가들을 칭찬했다.
이에 대한 보상으로 이들 국가는 일시적 10% 상호관세와 90일간 추가 관세 유예로부터 혜택을 받게 될 것이다.
바이오제약 산업은 트럼프 대통령의 첫 임기 동안을 포함하여 역사적으로 관세로부터 보호받아왔다.
트럼프 대통령은 자세한 내용을 밝히지 않았지만, 그의 발언은 특히 인도산 의약품에 의존하는 구매자들을 불안하게 만들었다. 인도는 미국에서 사용되는 모든 제네릭 의약품의 거의 절반을 공급하여 수십억 달러의 의료 비용을 절감하는 데 기여하고 있다.
미국은 인도의 연간 의약품 수출액 130억 달러 중 약 3분의 1을 구매하는 주요 시장이다. 인도 제약 회사들은 관세가 추가되면 가격을 인상해야 하며, 이로 인해 미국 내 의료 비용이 증가할 수 있다고 경고한다.
시플라(Cipla)와 닥터 레디스 래버러토리스(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) 같은 일부 회사는 미국에 공장을 가지고 있지만, 대부분은 수익성이 낮은 제네릭 의약품을 생산하기에는 비용이 너무 많이 든다고 말한다.
뱅크오브아메리카 증권 애널리스트는 트럼프 행정부가 제약 산업에 관세를 부과할 계획이라면 1962년 무역확장법에 따른 &#8216;섹션 232조 조사&#8217;를 통해 특정 상품 수입이 국가 안보를 위협하는지 여부를 결정할 가능성이 높다고 말했다.
232조 조사의 일반적인 일정은 약 1년이다. 여기에 동일한 일정이 적용된다면 의약품 수입에 대한 관세는 빠르면 올해 말에나 발효될 가능성이 높다. 제약 산업에 대한 232조 조사가 곧 시작될지는 확실하지 않지만, 최근 행정부의 발언을 보면 가능성이 있는 것으로 보인다. 하지만 조사를 시작한다고 해서 반드시 관세가 부과된다는 보장은 없다.
애널리스트 팀 앤더슨(Tim Anderson)은 2025년 1분기 실적 시즌이 곧 시작되므로 기업들이 실적 발표에서 잠재적 관세에 대해 논의할지 여부를 지켜볼 필요가 있다고 말한다.
즉, 실제 수익에 미치는 영향은 2025년 이후가 되어야 나타날 가능성이 높기 때문에 투자자들은 답변보다 더 많은 질문을 남길 수 있다.
웨드부시 애널리스트 댄 아이브스는 화요일에 "미국에서 그냥 만들 수 있다고 말하는 것은 아시아의 공급망이 실제로 얼마나 복잡한지, 그리고 지난 30년 동안 미국 소비자를 위해 전자, 칩, 반도체, 하드웨어 및 스마트폰이 어떻게 구축되어 왔는지를 과소평가하는 것"이라고 <a href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst">썼다</a>.
주요 제약 회사의 주가, 예를 들어 길리어드 사이언스(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), 머크 앤 컴퍼니(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), 일라이 릴리(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), 아스트라제네카(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), 로슈 홀딩스(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), 사노피(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), 노바티스(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), 아겐스(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB 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>), 노보 노디스크(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), 리제네론(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>), GSK(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) 및 화이자(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)는 수요일에 하락했다가 90일 관세 유예 발표 후 반등했다.
이 기사도 읽어보세요: <a href="https://kr.benzinga.com/news/usa/stocks/%ED%8A%B8%EB%9F%BC%ED%94%84%EC%9D%98-%EA%B9%9C%EC%A7%9D-%EA%B4%80%EC%84%B8-%EC%9C%A0%EC%98%88-%EA%B3%A8%EB%93%9C%EB%A7%8C%EC%82%AD%EC%8A%A4%EB%8A%94-%EA%B2%BD%EA%B8%B0%EC%B9%A8%EC%B2%B4-%EC%A0%84/">트럼프의 깜짝 관세 유예, 골드만삭스는 경기침체 전망 철회…美 증시 2008년 이후 일일 최대 상승</a>
사진 출처: MargJohnsonVA via Shutterstock
다른 트레이더들보다 30분 일찍 시장 움직임에 대한 독점 뉴스를 받아보세요.
Benzinga Pro의 독점 뉴스를 통해 수백만 명의 다른 트레이더보다 더 빠르게 유용한 투자 뉴스를 확인할 수 있습니다. <a href="https://www.benzinga.com/pro/register?t=be2bewe5mibe3bz3&amp;utm_source=bz-kor">여기를 클릭</a>하여 14일 무료 체험을 시작하세요.

<a href="https://www.benzinga.com/topic/ken-griffin" target="_blank" rel="noopener">켄 그리핀</a>의 <a href="https://www.benzinga.com/topic/citadel-securities" target="_blank" rel="noopener">헤지펀드 시타델(Citadel)</a>이 GSK PLC(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)에 3억 5,000만 파운드(3억 9,000만 달러)의 공매도 베팅을 걸었다. 이는 영국 제약 대기업 GSK에 대한 10년래 가장 큰 베팅이라고 파이낸셜타임스가 <a href="https://www.ft.com/content/6520c6eb-4a30-4909-9c86-1b6b2e471743" target="_blank" rel="noopener">보도했다</a>.
영국 금융감독청(Financial Conduct Authority)이 공개한 이 포지션은 GSK 발행 주식의 0.51%에 해당한다.
<h3>GSK의 랠리, 현실 검증에 직면</h3>
GSK 주가는 지난 한 달 동안 20억 파운드(약 25억 달러)의 자사주 매입과 HIV 및 암 치료제 판매 호조에 힘입어 8.20% 상승했다. 하지만 여전히 동종 업계에 뒤처져 있다.
지난 5년 동안 GSK 주가는 17.53% 하락한 반면 S&amp;P 500 제약 지수는 45% 급등했다. 시타델의 공매도는 특히 HIV 약물이 특허 절벽에 가까워지면서 GSK의 장기적인 파이프라인에 대한 회의적인 신호를 보낸다.
<h3>헤지펀드, 애널리스트들의 의견 엇갈려</h3>
헤지펀드가 GSK를 두고 움직인 것은 이번이 처음은 아니다. 2021년에는 행동주의 투자자 엘리엇 매니지먼트가 경영진 교체를 추진했다.
한편 JP모건 애널리스트들은 GSK의 최근 실적과 가이던스를 "긍정적"으로 보고 있지만 자사주매입 시점에 대해서는 의문을 제기하고 있다. 바클레이즈는 "예상치 못한 일"이라고 말했고, 제프리스는 "잘한 일"이라고 평가했다.
<h3>투자자를 위한 시사점</h3>
시타델의 GSK 베팅으로 인해 주가 변동성이 커질 수 있음으로 주목해야 할 것이다.
GSK의 도전 과제는 엇갈린 베팅으로 이어졌지만, GSK의 위험 없이 대형 제약사에 노출되기를 원하는 투자자는 일라이 릴리(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>)와 화이자(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) 같은 제약업계 선두 주식에 주목할 수 있다.
대안으로는 iShares U.S. Pharmaceuticals ETF(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IHE#NYSE">IHE</a>)와 SPDR S&amp;P Pharmaceuticals ETF(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XPH#NYSE">XPH</a>)를 통해 분산된 노출을 제공받을 수 있다.
이미지: Shutterstock
다른 트레이더들보다 30분 일찍 시장 움직임에 대한 독점 뉴스를 받아보세요.
Benzinga Pro의 독점 뉴스를 통해 수백만 명의 다른 트레이더보다 더 빠르게 유용한 투자 뉴스를 확인할 수 있습니다. <a href="https://www.benzinga.com/pro/register?t=be2bewe5mibe3bz3&amp;utm_source=bz-kor">여기를 클릭</a>하여 14일 무료 체험을 시작하세요.

네바다의 한 낙농업자가 1월에 루이지애나 남자의 사망과 관련된 조류 독감 D1.1 변종에 양성 반응을 보였다고 CNN이 <a href="https://www.cnn.com/2025/02/08/health/bird-flu-variant-nevada-human-case/index.html">보도</a>했다. 미국 질병통제예방센터(CDC)는 월요일에 <a href="https://www.benzinga.com/general/health-care/25/02/43549057/deadly-bird-flu-strain-hits-dairy-cows-could-make-covid-seem-like-a-walk-in-the-park-expert-says" target="_blank" rel="noopener" data-google-interstitial="false">초기 양성 반응</a>을 확인하기 위해 작업 중이다.
상세 내용: 초기 양성 반응을 보인 네바다의 낙농업자는 현재 결막염 또는 &#8220;핑크 아이&#8221;를 포함한 경미한 증상을 겪고 있으며, 이는 최근 인간 감염에서 흔히 나타나는 증상으로 보인다.
지난주 미국 농무부는 네바다주에 있는 6마리의 젖소가 <a href="https://www.benzinga.com/general/health-care/25/02/43549057/deadly-bird-flu-strain-hits-dairy-cows-could-make-covid-seem-like-a-walk-in-the-park-expert-says">조류 독감 D1.1 변종에 양성 반응</a>을 보였다고 밝혔다. 이는 H5N1 바이러스 변종이 소에서 처음으로 발견된 사례이다.
다음 읽기: <a href="https://www.benzinga.com/general/social-media/25/02/43535256/palantir-adds-elon-musks-ai-chatbot-grok-to-aip">팔란티어, 일론 머스크의 AI 챗봇 그록을 AIP에 추가하다</a>
CDC에 따르면 <a href="https://www.cdc.gov/bird-flu/situation-summary/index.html">현재 공공 보건</a> 위험은 낮다. 이 기관은 인플루엔자 감시 시스템을 사용하여 사람들에서 H5 조류 독감 활동을 모니터링하고 있다.
1월에 도널드 트럼프 대통령은 <a href="https://www.benzinga.com/general/health-care/25/01/43194764/trump-administration-halts-all-communications-from-the-centers-for-disease-control-as-bird-flu-spreads">CDC의 모든 커뮤니케이션을 중지하라고 명령</a>했다. 현재 CDC 웹사이트에는 &#8220;트럼프 대통령의 행정명령에 따라 수정 중이다&#8221;라는 배너가 표시되고 있다.
CDC는 지난 목요일에 2주 동안 중단되었던 주간 <a href="https://www.cdc.gov/mmwr/index2025.html?ACSTrackingID=USCDC_921-DM144964&amp;ACSTrackingLabel=This%20Week%20in%20MMWR:%20Vol.%2074,%20February%206,%202025&amp;deliveryName=USCDC_921-DM144964">과학 보고서</a>인 주간 질병 사망률 보고서를 다시 발표했다.
기타 사항: H5N1 조류 독감은 야생 조류와 가금류에서 계속 퍼지고 있다. 지난주에 퀸즈와 브롱크스 동물원에서 15마리의 조류가 조류 독감으로 사망했으며, 동물원 대변인은 &#8220;취약한 조류 종&#8221;이 보호 구역으로 옮겨졌다고 <a href="https://gothamist.com/news/bird-flu-suspected-in-deaths-across-multiple-species-at-queens-and-bronx-zoos">고다미스트(Gothamist)</a>에 밝혔다. 수의사들이 시, 주 및 연방 규제 기관과 협력하고 있다.
뉴욕 주지사 캐시 호컬은 퀸즈, 브루클린 및 브롱크스에서 조류 독감 사례가 발견된 후 뉴욕시, 웨스트체스터 및 롱아일랜드의 살아있는 가금류 시장을 폐쇄하라고 명령했다.
국가 신흥 특수 병원체 훈련 및 교육 센터에 따르면, 2022년 조류 독감 발생 이후 6천만 마리 이상의 가금류가 사망하거나 <a href="https://netec.org/2023/01/30/situation-report-highly-pathogenic-avian-influenza-ah5n1/">도살</a>되었습니다. 2024년 4분기에는 2천만 마리 이상의 산란용 닭이 도살되어 미국 가금류 산업에 큰 영향을 미쳤다.
주목할 주식: 또 다른 인간 조류 독감 사례가 발견된 것으로 보이면서, 투자자들은 조류 독감 백신과 관련된 다음 주식들을 주의 깊게 모니터링할 수 있다.
모더나(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>)는 1월에 미국 보건복지부로부터 mRNA 기반 인플루엔자 백신, 특히 조류 독감 백신 개발을 가속화하기 위해 추가로 5억 9천만 달러의 지원을 받았다.
GSK(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)는 2024년 7월에 큐어백 BV(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>)로부터 조류 독감 백신 후보에 대한 모든 권리를 인수하고 개발에 대한 1상/2상 연구를 시작했다. 노바백스(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) 또한 임상 시험 중인 조류 독감 백신 후보가 있다.
다음 읽기:
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<li><a href="https://www.benzinga.com/news/earnings/25/02/43512137/ford-shares-skid-after-q4-report-details">포드4분기 보고서 발표 후 주가 하락: 세부사항</a></li>
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미국 질병통제예방센터(CDC)가 세계보건기구(WHO)와의 협력을 중단한 것으로 알려지면서 전 세계 보건 우려가 월요일 높아지는 가운데, 캘리포니아에서 희귀한 H5N9 조류 독감 변종이 발견되어 백신 회의론자 로버트 F. 케네디 주니어에 대한 상원 인준 청문회가 예정된 것과 동시에 이루어졌다.
무슨 일이 있었나: 이러한 사태는 의료 관련 주식에 파장을 일으켰고, 백신 제조사들은 혼재된 반응을 보였다. 모더나(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>)는 월요일 0.58% 상승했고, 화이자(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)는 조류 인플루엔자 대비 준비 가능성에 대한 관심이 높아지면서 2.95% 상승했다.
CDC의 존 응켄가송(John Nkengasong) 공식의 일요일 메모는 <a href="https://apnews.com/article/cdc-who-trump-548cf18b1c409c7d22e17311ccdfe1f6">AP 통신</a>에 보도된 바와 같이 WHO와의 모든 협력을 즉시 중단하라는 명령을 내렸으며, 이는 미국이 올해 13건의 홍역 발병을 포함한 여러 건강 문제에 직면한 상황에서 건강 전문가들을 놀라게 했다.
첫 번째 H5N9 발생은 머시드 카운티의 한 오리 농장에서 발견되었으며, 더 일반적인 H5N1 바이러스와 함께 발견되어 119,000마리의 조류가 도살되었다고 로이터가 보도했다.
이 발견은 전국적으로 계란 가격이 12개에 4.15달러로 치솟은 12월에 발생했다. 미국 농무부는 조류 인플루엔자 영향으로 올해 계란 가격이 추가로 20% 상승할 것으로 전망하고 있다고 별도의 AP 통신 <a href="https://apnews.com/article/egg-prices-bird-flu-poultry-inflation-9ea9934e20e3fe393abb1bb85aa31c30">보도</a>했다.
타이밍은 특히 중요하다. 백신 회의론자로 알려진 케네디는 이번 주 보건복지부 장관 인준 청문회를 앞두고 있다. 그의 잠재적 임명은 이미 시장 심리에 영향을 미쳤으며, 일부 백신 주식은 변동성을 보였다.
&#8220;동시에 WHO와의 분리와 새로운 건강 위협이 발생하는 것은 의료 투자자들에게 상당한 불확실성을 야기한다&#8221;고 제프리 클라우스너(Jeffrey Klausner) 박사, 남가주대학교 공공보건 전문가가 말했다.
참고: <a href="https://kr.benzinga.com/news/usa/stocks/%EC%97%94%EB%B9%84%EB%94%94%EC%95%84-%EB%94%A5%EC%8B%9C%ED%81%AC%EA%B0%80-%EC%88%98%EC%B6%9C-%ED%86%B5%EC%A0%9C%EB%A5%BC-%EC%A4%80%EC%88%98%ED%95%98%EB%A9%B4%EC%84%9C-%EC%83%88-ai-%EB%AA%A8%EB%8D%B8/" target="_blank" rel="noopener">엔비디아가 딥시크를 &#8216;사례&#8217;로 언급하며 새로운 AI 모델이 수출 통제 준수 하에 생성될 수 있음을 설명</a>
중요한 이유: 의료 부문의 반응은 더 넓은 시장 우려를 반영한다. iShares Genomics Immunology and Healthcare ETF(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IDNA#NASDAQ">IDNA</a>)는 올해 1.2% 상승한 반면, <a href="https://www.benzinga.com/general/biotech/25/01/42882233/bird-flu-sparks-vaccine-stock-surge-etfs-to-watch-as-h5n1-outbreak-intensifies">주요 백신 생산자들</a>는 여전히 독감 대비를 위해 정부 계약을 상당수 보유하고 있다.
사노피 SA(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), 글락소스미스클라인 PLC(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) 그리고 다른 제조사들은 작년 10월 조류 인플루엔자 백신 생산을 위한 7,200만 달러의 연방 자금을 확보했다. 모더나는 mRNA 기반 H5N1 백신 개발을 위해 미국 보건부(HHS) 산하 질병예방대응본부(ASPR) 직속 생물의학첨단연구개발국(BARDA)로부터 1억 7,600만 달러를 별도로 받았다.
CDC의 결정은 도널드 트럼프 대통령의 WHO 탈퇴 명령에 따른 것이지만, 완전한 탈퇴는 의회의 <a href="https://www.benzinga.com/25/01/43125408/trump-signs-order-to-withdraw-us-from-who-again-cites-funding-governance-concerns">승인과 1년의 통지 기간</a>이 필요하다.

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<li><a href="https://kr.benzinga.com/crypto/bitcoin/%EB%B9%84%ED%8A%B8%EC%BD%94%EC%9D%B8-%EC%9D%B4%EB%8D%94%EB%A6%AC%EC%9B%80-%EB%B0%8F-%EB%8F%84%EC%A7%80%EC%BD%94%EC%9D%B8%EC%9D%B4-%EC%86%8C%ED%8F%AD-%ED%9A%8C%EB%B3%B5-%EB%94%A5%EC%8B%9C%ED%81%AC/" target="_blank" rel="noopener">비트코인, 이더리움, 도지코인, 딥시크 문제로 미국 기술주가 어려움을 겪는 동안 회복: 분석가는 BTC가 향후 2주 동안 새로운 최고가를 기록할 수 있다고 제안</a></li>
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