Latest news with #GSK
Business Recorder
6 hours ago
- Business
- Business Recorder
UK's FTSE 100 sees first weekly fall in six; Middle East tensions in focus
Britain's FTSE 100 snapped a five-week winning streak on Friday, closing out a week marred by a wave of global risk aversion amid the conflict between Israel and Iran, while a slew of interest rate verdicts were also assessed. The blue-chip FTSE 100 dipped 0.2% to hit a more than two-week low, while the midcap index ended 0.4% higher, though with marginal weekly losses. Drugmakers GSK and AstraZeneca were among the top drags on the FTSE 100, down 2.3% and 1.5% respectively. Heavyweight energy shares gave back some of their gains from earlier this week as crude oil prices also edged lower. BP lagged with a 2.1% decline. Oil prices came under pressure as the U.S. imposed new Iran-related sanctions, marking a diplomatic approach that fed hopes of a negotiated agreement. A week into the conflict, Iran said it would not discuss the future of its nuclear programme while under attack by Israel. London stocks fall as BoE keeps rates on hold A global risk-off move on tensions in the Middle East bogged down stocks around the world, although the UK's oil-heavy benchmark - down 0.8% for the week - outperformed a 1.5% drop in the Europe-wide STOXX 600. The week also saw a slew of central bank rate decisions, with both the Bank of England and the U.S. Federal Reserve choosing to hold their rates steady. Latest data showed UK retail sales saw their sharpest decline since December 2023 while consumer confidence rose to its highest level of 2025. Among headlining stocks, Berkeley dropped 8.2% after the homebuilder reported results and forecast fiscal 2026 and 2027 profits below market expectations and proposed the appointment of CEO Rob Perrins as executive chair. Metro Bank added 4% after two sources with knowledge of the matter told Reuters that the bank's biggest shareholder is open to selling his majority stake.
Yahoo
16 hours ago
- Business
- Yahoo
EMA Accepts GSK's Filing for Expanded Use of RSV Vaccine Arexvy
GSK plc GSK announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and above. With the EMA accepting the application for review, a final decision from the regulatory body in Europe is expected in the first half of 2026. Arexvy is currently approved for the prevention of lower respiratory tract disease ('LRTD') caused by RSV in all individuals aged 60 years and above, as well as for high-risk individuals aged 50-59 years. GSK is currently seeking approval for the expanded use of Arexvy in adults aged 18 years and above in the United States and Japan. Year to date, shares of GSK have risen 20.8% against the industry's decline of 0.6%. Image Source: Zacks Investment Research Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. However, sales of the vaccine have been lukewarm, mainly due to the revised recommendations for RSV vaccinations issued by the Advisory Committee on Immunization Practices ('ACIP') in June 2024. In June, the ACIP recommended the use of Arexvy for all adults aged 75 years and above. However, for adults aged 60-74 years, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. Arexvy generated sales worth £78 million in the first quarter of 2025, down 57% year over year due to lower demand in the United States. Pfizer's PFE Abrysvo is approved for the prevention of RSV-associated LRTD in all individuals aged 60 years and above, as well as in infants, through maternal immunization. PFE's Abrysvo is also approved for use in high-risk adults aged 18-59 years in the United States and Europe. Earlier this year, the ACIP recommended the expanded use of Arexvy and Abrysvo for use in adults aged 50-59 years who are at high risk for severe RSV disease. The updated ACIP recommendation lowers the recommended age for RSV vaccination from 60 years to 50 years for high-risk adults. The ACIP's recommendation is pending final approval by the director of the U.S. Centers for Disease Control and Prevention ('CDC') and the Department of Health and Human Services. Moderna's MRNA RSV vaccine, mResvia, was approved last year by the FDA and the European Commission to prevent RSV-LRTD in older adults aged 60 years and above. Last week, the FDA approved MRNA's mResvia for use in high-risk adults aged 18-59 years. Moderna is also working on expanding the vaccine's use in pediatric populations. We note that RSV vaccine sales have been weak across the industry for the 2024-2025 vaccination season due to the restrictive recommendation issued by the U.S. CDC last year for individuals in the 60-74 age bracket. mResvia generated sales worth $2 million during the first quarter of 2025, while sales of Pfizer's RSV vaccine, Abrysvo, fell 9% year over year to $131 million. GSK currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. Image Source: Zacks Investment Research GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. Image Source: Zacks Investment Research GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
CNBC
2 days ago
- Health
- CNBC
FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new option
The Food and Drug Administration on Wednesday approved Gilead's twice-yearly antiviral injection for preventing HIV – a milestone that the company and some experts say could help bring the world closer to ending the decades-long epidemic caused by the virus. But the launch of the injectable drug, lenacapavir, faces a set of potential threats, including the Trump administration's proposed cuts to federal funding for HIV prevention efforts. In two groundbreaking clinical trials last year, Gilead's injection proved to be capable of virtually eliminating new HIV infections when taken every six months. Patients take it less frequently than all existing HIV prevention medications, including daily pills from Gilead and another injection from GSK received every other month. That makes lenacapavir a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O'Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women. "It's hard to overstate the importance of this for global public health," O'Day said, adding that the injection "really will bend the arc of the epidemic as we roll this out across the globe." But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year. Gilead did not immediately share how much the injection will cost under its new use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment. In a statement ahead of the approval, Gilead said the pricing of lenacapavir for HIV prevention will be in line with existing branded PrEP options. A month's supply of Truvada and Descovy, Gilead's daily pills for PreP, are both around $2,000 without insurance. One dose of GSK's Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance. The company is also committed to supplying the drug for that use globally as the virus "knows no boundaries," O'Day said. Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries. Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O'Day said. PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men. Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu. "Unfortunately, there's still enormous amount of stigma and cultural challenges when it comes to HIV prevention," Johanna Mercier, Gilead's chief commercial officer, said in an interview. "Getting a twice-a-year injection really gives you that privacy that people have been looking for." She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and efficacy of the company's injection. In one late-stage trial, 99.9% of patients who took Gilead's injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead's daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth. Another trial on cisgender women found that none of the participants who received Gilead's injection contracted an HIV infection, demonstrating 100% efficacy. In the U.S., ensuring access to underserved populations will also require broad insurance coverage. While most PrEP users are under commercial plans, the federal Medicaid program is also crucial to reaching lower-income communities. Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults with HIV, according to health policy research organization KFF. That makes Republicans' proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access. Mercier said, as of now, Gilead believes that Medicaid will continue to cover HIV services and support. "There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up," she said, also pointing to Gilead's programs for uninsured individuals. But PrEP4All's Johnson said the "entire foundation for HIV prevention in America is under attack at this moment." Other proposed federal funding cuts could make it harder to get Gilead's injection into the hands of physicians and patients, Johnson said. For example, the White House's proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those run through the CDC. While some funding streams are continuing, Johnson said they are doing so "in a way that would completely destabilize the entire field of HIV prevention." He said if Congress does not push back on the proposed cuts, people currently taking PrEP "could start to slip off" and HIV infections could rise in many communities.
Globe and Mail
2 days ago
- Business
- Globe and Mail
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK Specialty Medicines Unit on a Strong Footing GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK's Promising Pipeline GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's Vaccine Sales Slowing Down GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK's Price Performance, Valuation & Estimate Movement GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. GSK Stock Outperforms Industry, Sector and S&P GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. GSK Stock Valuation Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. GSK's Estimates Stay Invested in GSK Stock GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Novo Nordisk A/S (NVO): Free Stock Analysis Report Eli Lilly and Company (LLY): Free Stock Analysis Report AbbVie Inc. (ABBV): Free Stock Analysis Report
