La chaîne d'options affiche les données clés des options sur actions de GSK à différents prix d'exercice et dates d'expiration. Les traders utilisent ces informations pour analyser les transactions potentielles et évaluer le sentiment du marché pour GSK..

GSK (NYSE:GSK) Stock, Chaîne d'Options

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.

GlaxoSmithKline

<ul>
<li>Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) for HIV treatment and assess experiences of using Apretude (cabotegravir long-acting (CAB LA) for PrEP)in range of populations</li>
<li>New phase IIIb data look at preferences among treatment-naive adults offered the choice to switch to CAB+RPV LA after attaining rapid viral suppression with Dovato (DTG/3TC) daily oral therapy</li>
<li>Interim data from wave three of the Positive Perspectives study demonstrate impact of joint decision-making on HIV treatment satisfaction and health outcomes</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of abstracts from its innovative HIV treatment and prevention portfolio at the International AIDS Society 2025 Conference (IAS 2025) in Kigali, Rwanda. Key data will highlight the long-term effectiveness of Vocabria &amp; Rekambys, (branded as Cabenuva in the US, Canada and Australia) the company's complete long-acting injectable regimen for treatment; evaluate patient preference for long-acting injectables compared to daily oral therapy; and measure benefits of long-acting injectables in tackling common challenges associated with taking daily pills, including stigma and adherence.

Biotech

News

General

ViiV Healthcare Showcases Data At IAS 2025 Highlighting Long-Term Effectiveness And Patient Preference For Long-Acting HIV Injectables Vocabria + Rekambys And Apretude Over Daily Oral Therapy

<a href="https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults" title="https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults">https://www.gov.uk/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults</a>

UK's MHRA Says There Is Small Increase In Risk Of Guillain-Barré Syndrome Post Vaccination With Abrysvo And Arexvy In Adults Aged 60 Years & Older; Commission On Human Medicines Advise That Benefits Of Vaccination Against RSV Outweigh Small Risk Of Developing Guillain-Barré Syndrome; Currently No Evidence Of Increased Risk Of Guillain-Barré Syndrome In Pregnant Women Following Vaccination With Abrysvo

The House Judiciary Committee has subpoenaed Dr. Philip Dormitzer, a former Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) executive, in connection with an investigation into claims that the company intentionally delayed the release of <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">clinical testing results</a> for its COVID-19 vaccine until after the 2020 presidential election.
The move signals an escalation in the panel's probe into whether political considerations influenced Pfizer's vaccine announcement timeline.
Dormitzer, who later joined British drugmaker GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), is considered a key witness in the inquiry.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/46123159/pfizer-seeks-label-expansion-for-hemophilia-drug-after-promising-data" rel="noreferrer noopener">Pfizer Seeks Label Expansion For Hemophilia Drug After Promising Data</a>
Benzinga reached out to Pfizer for comment.
According to the committee, he has not voluntarily complied with previous requests to appear or provide documents.
The subpoena, first reported by CNN, reflects lawmakers&#8217; belief that Dormitzer&#8217;s testimony is central to understanding internal decision-making at Pfizer during the development of the vaccine.
The committee points to allegations that Dormitzer, after joining GSK, told colleagues that Pfizer had deliberately delayed disclosing the vaccine&#8217;s effectiveness until after Election Day.
The CNN <a target="_blank" href="https://edition.cnn.com/2025/06/30/politics/pfizer-covid-vaccine-philip-dormitzer" rel="noreferrer noopener">report </a>added that the Wall Street Journal previously reported that GSK had flagged those statements to federal prosecutors in New York.
According to House Judiciary Chair Jim Jordan, GSK provided information from a human resources meeting in November 2024 in which Dormitzer allegedly expressed concern about being investigated by a future Trump administration, suggesting the vaccine announcement timing was "not a coincidence."
Further, Jordan's letter cites claims that Dormitzer informed colleagues that Pfizer&#8217;s top R&amp;D leadership intentionally slowed clinical testing so that it would not conclude before the election results were known. The Judiciary Committee has received some records from GSK but has not made them public.
Pfizer announced the COVID-19 vaccine's effectiveness on Nov. 9, 2020, six days after Election Day.
CEO Albert Bourla has previously denied political motives, telling CNN that the timing was based solely on data readiness and regulatory review, not election considerations.
While the committee has not issued a subpoena to Pfizer, it seeks information directly from the company as the investigation progresses.
Price Action: PFE stock is currently 0.80% higher at $25.24, as of the last check on Wednesday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/tech/25/07/46226585/microsoft-cuts-9000-jobs-in-second-2025-layoff" target="_blank" rel="noreferrer noopener">Microsoft Cuts 9,000 Jobs In Second 2025 Layoff As AI Expansion Pushes Cost Controls</a></li>
</ul>
Photo: Shutterstock

Large Cap

Health Care

Legal

Lawmakers Investigate Whether Pfizer Delayed COVID-19 Vaccine Results For Political Reasons

In the current session, GSK Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) is trading at $38.51, after a 1.13% drop. Over the past month, the stock fell by 5.54%, and in the past year, by 0.77%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. 

<img src="https://www.benzinga.com/files/images/story/2025/1751475959_0.png" alt="Past Year Chart" />

<h3>How Does GSK P/E Compare to Other Companies?</h3>
The P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historical earnings, and the industry at large. A lower P/E could indicate that shareholders do not expect the stock to perform better in the future or it could mean that the company is undervalued. 
GSK has a lower P/E than the aggregate P/E of 27.89 of the Pharmaceuticals industry. Ideally, one might believe that the stock might perform worse than its peers, but it's also probable that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2025/1751475959_1.png" alt="Guage" />

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

Intraday Update

Markets

Price Over Earnings Overview: GSK

U.S. Senator Maggie Hassan (D-NH) is intensifying her scrutiny of GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) over the company's decision to pull its widely used asthma inhaler, Flovent HFA, from the market.
One year after the discontinuation, Hassan launched a formal investigation into the move, raising alarms about patient access, skyrocketing costs, and the financial burden placed on Medicaid.
Flovent HFA had long been the most <a target="_blank" href="https://www.hassan.senate.gov/news/press-releases/senator-hassan-launches-investigation-into-gsk-on-impact-of-its-discontinuation-of-childrens-asthma-inhaler" rel="noreferrer noopener">prescribed</a> controller inhaler for young children with asthma. After it was removed from the market in January 2024, GSK partnered with Prasco Laboratories to distribute an authorized generic version.
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>
This rebranded product has been significantly more expensive for patients, allowing GSK to avoid an estimated $367.6 million in Medicaid rebates in 2024 alone. Instead, Medicaid spent over $550 million on the authorized generic in 2024.
In a <a target="_blank" href="https://www.hassan.senate.gov/imo/media/doc/2025-06-27%20Hassan%20to%20GSK%20-%20Copy_Redacted.pdf" rel="noreferrer noopener">letter</a> to the CEO, Emma Walmsley, Senator Hassan criticized the maneuver as a corporate strategy that prioritized profits over patients, stating that it threatened the lives of children and placed undue financial strain on families. "GSK's decision to allow a different company to sell the same product in a more expensive form has endangered children and fleeced taxpayers," she said.
Hassan <a target="_blank" href="https://www.hassan.senate.gov/news/press-releases/senator-hassan-presses-big-pharma-company-to-restore-access-to-low-cost-asthma-inhalers-for-children" rel="noreferrer noopener">urged</a> GSK to restore the original Flovent HFA and work with Prasco to reduce the cost of the generic version.
In her May 2024 letter, Hassan questioned why GSK discontinued Flovent HFA while keeping other brand-name inhalers on the market and capping their prices. GSK's response did not clarify this; instead, it shifted responsibility to Prasco for pricing decisions and formulary negotiations.
While GSK claimed the generic was priced 35% lower than branded Flovent, previous rebates on the original product had made it significantly more affordable. The absence of such rebates for the generic has led many insurers and pharmacy benefit managers to delay or deny coverage.
The consequences have been severe. Pediatric providers reported that Flovent HFA was the only inhaler compatible with spacer devices for infants and young children.
Its removal has limited treatment options, especially for patients with eosinophilic esophagitis or those who cannot tolerate alternatives. Meanwhile, other substitute inhalers, like Asmanex HFA and Alvesco, have faced shortages or limited insurance coverage throughout 2024.
A study published in October 2024 revealed a 17.5% increase in asthma-related hospitalizations in the three months after Flovent's removal, followed by a 24.1% increase over the next three to six months compared to previous years. ICU admissions showed similar spikes.
Beyond health outcomes, the financial impact has been substantial. A Johns Hopkins analysis found that Medicaid spent an estimated $551.8 million on the authorized generic in 2024 — nearly double what it might have spent under the original rebate structure. Even insured patients reported paying up to $150 per inhaler.
Senator Hassan's investigation aims to hold GSK accountable and prevent similar corporate tactics that bypass rebate obligations at the expense of public health.
Price Action: GSK stock is trading lower by 0.03% to $38.54 at the last check Friday
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/analyst-stock-ratings/upgrades/25/06/46146899/this-is-googles-secret-weapon-to-outpace-chatgpt-in-the-search-war" target="_blank" rel="noreferrer noopener">This Is Google's Secret Weapon To Outpace ChatGPT In Search War</a></li>
</ul>
Photo via Shutterstock

Government

GSK Rebranded Flovent Asthma Inhaler For Children To Avoid $367 Million Medicaid Rebate, Senator Hassan Accuses

GSK Announces FDA Approval Of Benlysta Autoinjector For children With Active Lupus Nephritis

<ul>
<li>If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference</li>
<li>Submission based on data from positive GLISTEN phase III trial</li>
</ul>

The European Medicines Agency Accepts For Review GSK's Marketing Authorization Application For Linerixibat For Cholestatic Pruritus In Patients With Primary Biliary Cholangitis

In the holiday-shortened week, these ten large-cap stocks were the worst performers. Are they a part of your portfolio?
<ol class="wp-block-list">
<li>AppLovin Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APP#NASDAQ">APP</a>) stock fell 14.68% last week, continuing its fall after a short-sell report <a href="https://www.benzinga.com/trading-ideas/short-ideas/25/06/45910389/short-seller-says-applovin-is-desperate-and-doomed-shares-slide" target="_blank" rel="noreferrer noopener">issued by Culper Research</a>.</li>
<li>First Solar, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FSLR#NASDAQ">FSLR</a>) stock lost 13.6% last week amid a broader decline in solar stocks after the U.S. Senate Finance Committee unveiled its version of President Trump's tax bill, which <a href="https://www.benzinga.com//node/45971345" target="_blank" rel="noreferrer noopener">slashed renewable energy incentives</a>.</li>
<li>James Hardie Industries plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JHX#NYSE">JHX</a>) stock declined 11.23%.</li>
<li>BeOne Medicines Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONC#NASDAQ">ONC</a>) stock dipped 10.65% last week.</li>
<li>GlaxoSmithKline plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) stock dropped 10.4% last week.</li>
<li>Accenture plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ACN#NYSE">ACN</a>) stock fell 10.3% amid a selloff following the company's Q3 financial results.</li>
<li>Arista Networks, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ANET#NYSE">ANET</a>) stock declined 9.94% amid a tech sector pullback driven by rising Middle East tensions between Israel and Iran.</li>
<li>Li Auto Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LI#NASDAQ">LI</a>) stock fell 9.91% amid China's suspension of trade-in subsidies for EVs and fuel-efficient cars in key urban markets.</li>
<li>Corpay, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CPAY#NYSE">CPAY</a>) stock fell 9.64% last week amid pressure from Coinbase Global&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COIN#NASDAQ">COIN</a>) announcement of its <a href="https://www.benzinga.com//node/46004688" target="_blank" rel="noreferrer noopener">new stablecoin payments</a> stack, which may impact Corpay's business outlook.</li>
<li>Mastercard Incorporated (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MA#NYSE">MA</a>) stock lowered 9.56% last week amid a broader selloff in credit card stocks following Coinbase's launch of <a href="https://www.benzinga.com//node/46004688" target="_blank" rel="noreferrer noopener">its stablecoin payments infrastructure</a>.</li>
</ol>
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/tech/25/06/46043303/consumer-tech-news-june-16-june-20-fed-holds-rates-trump-eyes-iran-moves-apple-taps-ai-accenture-shifts-strategy" target="_blank" rel="noreferrer noopener">Consumer Tech News (June 16-June 20): Fed Holds Rates, Trump Eyes Iran Moves, Apple Taps AI, Accenture Shifts Strategy</a></li>
<li><a href="https://www.benzinga.com/trading-ideas/movers/25/06/46043524/ast-spacemobile-and-coinbase-global-are-among-top-10-large-cap-gainers-last-week-june-16-20-are-the-others-in-your-portfolio">AST SpaceMobile And Coinbase Global Are Among Top 10 Large Cap Gainers Last Week (June 16-20): Are The Others In Your Portfolio?</a></li>
</ul>
Photo via Shutterstock

Movers

ANET

COIN

CPAY

FSLR

AppLovin, First Solar And Li Auto Are Among Top 10 Large Cap Losers Last Week (June 16-20): Are The Others In Your Portfolio?

During market trading hours on Wednesday, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) Yeztugo&nbsp;(lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">who need or want PrEP</a>.
Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. 
The first PrEP medication, which was also developed by Gilead, was approved in the <a href="https://www.benzinga.com/pressreleases/25/06/b46004872/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months" target="_blank" rel="noreferrer noopener">U.S. in 2012</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/large-cap/25/06/45982235/gileads-hiv-prevention-drug-could-be-manufactured-at-shocking-low-cost-report" rel="noreferrer noopener">Gilead&#8217;s HIV Prevention Drug Could Be Manufactured At Shocking Low Cost: Report</a>
In the&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2024%2Ffull-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024&amp;esheet=54257682&amp;newsitemid=20250520465880&amp;lan=en-US&amp;anchor=PURPOSE+1+trial&amp;index=4&amp;md5=75b8ce4877adca4271276392d97406cf" rel="noreferrer noopener">PURPOSE 1 trial</a>, data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada&nbsp;(emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF)&nbsp;in cisgender women in sub-Saharan Africa.
In the&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gilead.com%2Fnews%2Fnews-details%2F2024%2Fgilead-presents-full-purpose-2-data-results-for-twice-yearly-lenacapavir-for-hiv-prevention-at-hiv-glasgow&amp;esheet=54257682&amp;newsitemid=20250520465880&amp;lan=en-US&amp;anchor=PURPOSE+2+trial&amp;index=6&amp;md5=9249be8d81ad64a52dab27c8a0a16b25" rel="noreferrer noopener">PURPOSE 2 trial</a>, there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada.
In both trials, Yeztugo, the company&#8217;s injectable HIV-1 capsid inhibitor, also demonstrated superiority in the prevention of HIV infections when compared with background HIV incidence (bHIV)&nbsp;and was generally well-tolerated, with no significant or <a target="_blank" href="https://www.benzinga.com/markets/biotech/25/06/45799258/gileads-hiv-pipeline-gains-traction-with-upcoming-fda-decision-for-hiv-1-drug" rel="noreferrer noopener">new safety concerns identified</a>.&nbsp;
In the U.S., Gilead is working closely with insurers, healthcare systems and other payers to ensure broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead&#8217;s Advancing Access&nbsp;Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.
Gilead has submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) applications with the European Medicines Agency (EMA),&nbsp;both of which the EMA has validated&nbsp;and will review under an accelerated assessment timeline.
Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia,&nbsp;Brazil, Canada, and&nbsp;South Africa.
<h2 class="wp-block-heading">Pricing</h2>
Citing an <a target="_blank" href="https://www.cnbc.com/2025/06/18/fda-approves-gilead-hiv-prevention-injection-lenacapavir.html" rel="noreferrer noopener">email</a> from a Gilead spokesperson, CNBC noted that Yeztugo&#8217;s annual list price in the U.S. before insurance is $28,218.
A month&#8217;s supply of Truvada and Descovy, Gilead&#8217;s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year.
One dose of GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs <a target="_blank" href="https://viivuspricing.com/apretude.html" rel="noreferrer noopener">roughly $4,000</a> before insurance.
Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General, <a href="https://www.eatg.org/hiv-news/unaids-urges-gilead-to-drop-price-of-new-hiv-prevention-shot/" target="_blank" rel="noreferrer noopener">said</a>, &#8220;Lenacapavir could be the tool we need to bring new infections under control, but only if it is priced affordably and made available to everyone who could benefit.&#8221;
&#8220;UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of rollout. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing&#8230;,&#8221; Byanyima added.
AIDS Healthcare Foundation President Michael Weinstein sharply criticized Gilead&#8217;s outrageous pricing, <a target="_blank" href="https://www.businesswire.com/news/home/20250618031796/en/AHF-Gileads-Greed-Kills-Promise-of-Lenacapavir-for-HIV-Prevention" rel="noreferrer noopener">saying</a>, &#8220;What could be an extraordinary game changer for HIV prevention is being completely undermined by Gilead&#8217;s greed. Charging $28,218 a year will drastically limit the availability of the drug. Gilead continues to feast on tens of billions of dollars, much of which is public funding for their HIV portfolio, at the expense of people living with or at risk of acquiring HIV.&#8221;
Price Action: GILD stock is trading higher by 1.16% to $109.25 premarket at last check Friday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/25/03/44284430/merck-plans-regulatory-submission-for-two-drug-regime-for-hiv-infection-by-mid-2025" target="_blank" rel="noreferrer noopener">Merck Plans Regulatory Submission For Two-Drug Regime For HIV Infection By Mid-2025</a></li>
</ul>
Photo by Tada Images via Shutterstock

GILD

FDA Approves Gilead's 'Game Changing' Twice-Yearly Shot To Prevent HIV Transmission, Critics Slam $28K Price Tag

The U.S. Food and Drug Administration (FDA) expanded approval of Moderna Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) respiratory syncytial virus vaccine to adults aged 18-59 at increased risk for disease.
What Happened: The FDA on Thursday approved broader use of Moderna&#8217;s mRESVIA vaccine for younger at-risk adults based on late-stage trial results, reported Reuters.
The mRNA-based shot showed significant immune responses in adults with underlying health conditions and maintained a favorable safety profile. The vaccine was previously limited to adults 60 and older, where it demonstrated 79% efficacy against RSV symptoms.
Health Secretary Robert F. Kennedy Jr. simultaneously <a href="https://www.benzinga.com/news/health-care/25/06/45898417/rfk-jr-appoints-vaccine-critics-to-cdc-vaccine-panel-after-firing-entire-advisory-committee-report">appointed eight new members to the CDC&#8217;s Advisory Committee</a> on Immunization Practices, including prominent mRNA vaccine critics Robert Malone and Retsef Levi.
The health secretary fired all 17 existing panel members, claiming the need to <a href="https://www.benzinga.com/news/health-care/25/06/45853393/robert-kennedy-jr-axes-entire-cdc-vaccine-panel-to-restore-public-trust-pfizer-moderna-other-biotech-stocks-drop-in-after-hours-trading">&#8220;re-establish public confidence in vaccine science.&#8221;</a> The committee provides crucial guidance on vaccine recommendations that influence insurance coverage and policy.
The CDC currently recommends RSV vaccines for adults 75 and older, plus those 60-74 at increased risk. The final CDC recommendation remains pending for the expanded age group before availability.
See Also: <a href="https://www.benzinga.com/markets/economic-data/25/06/45919422/trumps-one-big-beautiful-bill-is-the-largest-redistribution-from-poor-to-rich-in-american-history-says-economist-justin-wolfers-amid-tax-cuts-spending-s">Trump&#8217;s &#8216;One Big, Beautiful Bill&#8217; Is &#8216;The Largest Redistribution From Poor To Rich In American History,&#8217; Says Economist Justin Wolfers Amid Tax Cuts, Spending Slashes And Tariffs</a>
Why It Matters: William Blair analysts noted the <a href="https://www.benzinga.com/news/fda/25/06/45719840/modernas-new-covid-vaccine-secures-fda-clearance-for-seniors-at-risk-individuals">approval represents</a> &#8220;an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.&#8217;s negative public opinion on mRNA COVID-19 vaccines.&#8221; However, they cautioned that approval alone won&#8217;t massively boost COVID vaccine sales, which depend primarily on overall vaccination market sentiment.
The advisory panel restructuring creates regulatory uncertainty for vaccine manufacturers. Kennedy&#8217;s broader policy changes include removing COVID vaccines from <a href="https://www.benzinga.com/government/regulations/25/05/45688464/rfk-jr-drops-covid-vaccine-recommendation-for-healthy-kids-but-experts-warn-of-major-risks">recommended schedules for healthy children and pregnant women</a>, plus terminating Moderna&#8217;s $600 million bird flu vaccine contract.
RSV hospitalizes 15,000-20,000 U.S. adults aged 50-59 annually. Competing vaccines from Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and GSK plc (LSE: GSK) also target similar demographics, intensifying market competition amid shifting federal oversight. Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/crypto/cryptocurrency/25/06/45919626/coinbase-ceo-brian-armstrong-teases-crypto-credit-card-powered-by-american-express-bitcoin-cashbacks-offered-but-heres-the-catch">Coinbase CEO Brian Armstrong Teases Crypto Credit Card Powered By American Express—Bitcoin Cashbacks Offered, But Here&#8217;s The Catch</a></li>
</ul>
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: Lutsenko_Oleksandr / Shutterstock.com

MRNA

FDA Expands Moderna's RSV Vaccine Use To At-Risk Adults Aged 18–59 Amid CDC Panel Shake-Up

During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the health care sector.
<h3 class="wp-block-heading">Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 7.37%</li>
<li>UBS analyst Trung Huynh maintained a Neutral rating and raised the price target from $24 to $25 on April 30, 2025. This analyst has an accuracy rate of 70%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating on March 18, 2025. This analyst has an accuracy rate of 74%.</li>
<li>Recent News: Arvinas, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARVN#NASDAQ">ARVN</a>) on Friday announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) with its partner Pfizer.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609">latest PFE news</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609"><img loading="lazy" decoding="async" width="882" height="842" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114.png" alt="" class="wp-image-943187" style="width:620px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114.png 882w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114-300x286.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091603/image-114-768x733.png 768w" sizes="(max-width: 882px) 100vw, 882px" /></a></figure>
<h3 class="wp-block-heading">Merck &amp; Co., Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 4.10%</li>
<li>Citigroup analyst Andrew Baum downgraded the stock from Buy to Neutral and cut the price target from $115 to $84 on May 14, 2025. This analyst has an accuracy rate of 69%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating with a price target of $115 on April 17, 2025. This analyst has an accuracy rate of 74%.</li>
<li>Recent News: On Monday, Merck reported positive topline results from the first two Phase 3 CORALreef trials evaluating enlicitide decanoate for the treatment of adults with hyperlipidemia.</li>
<li>Benzinga Pro's real-time newsfeed alerted to latest MRK <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609">news </a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609"><img loading="lazy" decoding="async" width="857" height="832" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115.png" alt="" class="wp-image-943188" style="width:582px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115.png 857w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115-300x291.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091645/image-115-768x746.png 768w" sizes="(max-width: 857px) 100vw, 857px" /></a></figure>
<h3 class="wp-block-heading">GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 3.88%</li>
<li>Oppenheimer analyst Rupesh Parikh maintained an Outperform rating and raised the price target from $87 to $93 on Feb. 13, 2025. This analyst has an accuracy rate of 72%.</li>
<li>Canaccord Genuity analyst Susan Anderson maintained a Buy rating and increased the price target from $93 to $100 on Feb. 7, 2025. This analyst has an accuracy rate of 67%.</li>
<li>Recent News: GSK and Spero Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPRO#NASDAQ">SPRO</a>), on May 28, announced that the pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop early for efficacy.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest GSK <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609">news </a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0609"><img loading="lazy" decoding="async" width="863" height="838" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116.png" alt="" class="wp-image-943189" style="width:552px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116.png 863w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116-300x291.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/09091720/image-116-768x746.png 768w" sizes="(max-width: 863px) 100vw, 863px" /></a></figure>
<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"> 
<div class="wp-block-embed__wrapper">
<iframe loading="lazy" title="How to Find Dividend Stocks: Scan, Analyze, and Capture with Benzinga Pro" width="500" height="281" src="https://www.youtube.com/embed/pVF0O2lsEH4?start=1&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
</div>
</figure>
Read More: 
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/trading-ideas/long-ideas/25/06/45811726/cramer-says-hes-not-going-to-really-want-to-do-a-lot-of-china-right-now">Cramer Says He&#8217;s &#8216;Not Going To Really Want To Do A Lot Of China Right Now&#8217;</a> </li>
</ul>
Photo via Shutterstock

Long Ideas

Dividends

Price Target

Pre-Market Outlook

Analyst Ratings

Trading Ideas

ARVN

SPRO

Wall Street's Most Accurate Analysts Spotlight On 3 Health Care Stocks Delivering High-Dividend Yields

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.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/health-care/25/06/45756266/alto-neuroscience-adds-intriguing-depression-asset-via-over-100-million-deal">Alto Neuroscience Adds &#8216;Intriguing&#8217; Depression Asset Via Over $100 Million Deal</a></li>
</ul>
Image via Shutterstock

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.
Read Next:
<ul class="wp-block-list">
<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.
Read Next:
<ul class="wp-block-list">
<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. 
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/general/biotech/25/05/45629452/why-is-teva-stock-trading-higher-on-tuesday" target="_blank" rel="noreferrer noopener">Why Is Teva Stock Trading Higher On Tuesday?</a></li>
</ul>
Image: Shutterstock

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:
<ul class="wp-block-list">
<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

Press Releases

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

GSK announces the Linked by Lupus: Optimal Care Initiative to help support individuals with lupus in the US

FDA approves Benlysta (belimumab) Autoinjector for children with active lupus nephritis

ALEC

PRSO

SGBX

TBPH

Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

Axsome Therapeutics

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

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

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

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

Haleon

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Regencell Bioscience Holdings Limited - Ordinary Shares

Regencell Bioscience

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

Sanofi

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)

Comments

GSK

GSK (GSK) Options

GSK (NYSE:GSK) Stock, Chaîne d'Options

Notizie

PARTENAIRE / CONTRIBUTEUR

BENZINGA MONDIAL