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| 28.06.25 16:39:20 | GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment |  |
| GSK plc (NYSE:GSK) is one of the 11 best European stocks to invest in. On June 24, the company announced receipt of FDA approval for a 200 mg/mL autoinjector of Benlysta (belimumab) for the treatment of active lupus nephritis (LN). The approval applies to children aged five years and above.GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment A pharmacist looking at a prescription bottle of gastrointestinal drugs. Benlysta autoinjector is the first-of-its-kind treatment option for at-home administration. The drug is a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody. It works by binding to soluble BLyS, which inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. It does not bind B cells directly. The 200 mg/mL autoinjector was previously approved for pediatric patients with active systemic lupus erythematosus (SLE) in 2024. Benlysta was the first and only approved biologic for both SLE and lupus nephritis in over 50 years, including for the pediatric population. The autoinjector will be available for patients and their caregivers immediately. GSK plc (NYSE:GSK) is a UK-based global biopharmaceutical company. It researches, develops, and sells medicines and vaccines for infectious diseases, HIV, respiratory conditions, cancer, and immune-related disorders. Its key products include Shingrix (shingles vaccine), Nucala (asthma), and HIV treatments through its ViiV Healthcare joint venture. While we acknowledge the potential of GSK as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Best Value Penny Stocks to Buy According to Analysts and 12 Best Augmented Reality Stocks to Buy According to Analysts. Disclosure: None. View Comments |
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| 26.06.25 13:00:00 | Ephicacy Appoints Névine Zariffa to Its Board of Directors |  |
| ISELIN, N.J., June 26, 2025--(BUSINESS WIRE)--Ephicacy Consulting Group, Inc., a leading biometrics contract research organization, today announced the addition of Névine Zariffa to the board. Névine is a recognized leader in biostatistics and data science with more than 25 years of experience in drug development, including senior roles at GlaxoSmithKline and AstraZeneca, where she led the Enterprise Data & Analytics initiative. Névine has contributed to over 200 drug development programs across multiple therapeutic areas and all phases of drug development and authored more than 30 peer-reviewed publications. She served on the Board of CDISC and advised the FDA’s Office of the Commissioner during the COVID-19 pandemic. She is currently a strategic advisor to multiple organizations from large pharma to health tech startups. "I’m excited to join Ephicacy’s board and contribute to an organization that is well regarded for the quality of its people and the work they do," said Névine. "I look forward to working with fellow board members and the leadership team to help shape strategies that deliver impact for their clients’ important work to advance healthcare options for patients." "With decades of industry experience and a proven track record across all phases of drug development, Névine brings the kind of strategic insights that will be invaluable as we navigate the evolving landscape of innovation and evidence generation," said Tara Gladwell, CEO of Ephicacy. About Ephicacy Consulting Group, Inc. Headquartered in Iselin, NJ, with employees and operations across North America and India, Ephicacy is a rapidly growing biometrics CRO, providing outsourced statistical programming, biostatistics, data management, and real-world evidence analytics services to pharmaceutical and biotechnology companies. Since its founding in 2005, Ephicacy has established itself as a leading player in the clinical analytics space, leveraging a global talent pool to help global pharmaceutical and biotechnology companies reduce their time to market in a cost-effective manner. More information on the Company and its services can be viewed online at https://www.ephicacy.com/. About Great Point Partners Great Point Partners, founded in 2003 and based in Greenwich, CT, is a leading health care investment firm with 30 professionals, investing in the United States, Canada, and Western Europe. GPP is currently making new minority and majority private equity investments from GPP IV. Great Point manages approximately $1.5B of capital (including committed and uncalled capital) in its private funds and public life sciences equity strategy (BioMedical Value Fund). Great Point Partners has provided growth equity, growth recapitalization, and management buyout financing to more than 100 growing health care companies. The private equity funds invest across all sectors of the health care industry with a particular emphasis on biopharmaceutical services and supplies, alternate site care, medical device contract manufacturing and information technology enabled businesses. The firm pursues a proactive and proprietary approach to sourcing investments and tuck-in acquisitions for its portfolio companies. Story Continues View source version on businesswire.com: https://www.businesswire.com/news/home/20250626061281/en/ Contacts Gabe Martinez SCORR Marketing (308) 338 2304 PR@scorrmarketing.com View Comments |
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| 24.06.25 16:15:00 | EMA Accepts GSK's Filing for Linerixibat in Rare Disease-Related Itch | |
| GSK plc GSK announced that the European Medicines Agency has accepted its marketing authorization application (MAA) seeking approval of its investigational ileal bile acid transporter (“IBAT”) inhibitor, linerixibat, for treating cholestatic pruritus in patients with primary biliary cholangitis (“PBC”). Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure. A regulatory filing seeking approval for linerixibat for the given indication is currently under review in the United States. A final decision from the FDA is expected on March 24, 2026. Year to date, shares of GSK have increased 13.1% against the industry’s decline of 3.3%.Zacks Investment Research Image Source: Zacks Investment Research GSK's MAA for Linerixibat Based on GLISTEN Study The MAA for linerixibat was based on positive data from the phase III GLISTEN study. The study met both the primary and key secondary endpoints, wherein treatment with linerixibat led to a rapid, significant and sustained improvement in cholestatic pruritus and itch-related sleep interference as compared to placebo. Management believes that linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally, a condition for which only a few effective treatments are available presently. Growing Competition in the PBC Market Some other companies are also developing treatments for PBC, as there remains a high unmet medical need. Last August, the FDA granted accelerated approval to Gilead Sciences’ GILD seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (“UDCA”), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. GILD markets seladelpar under the trade name Livdelzi in the United States. Earlier this year, the European Commission granted conditional marketing authorization to GILD’s seladelpar for the given indication. Mirum Pharmaceuticals MIRM is developing its pipeline candidate, volixibat, an oral IBAT inhibitor, for the treatment of PBC. The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC. Mirum expects to complete enrollment in the VANTAGE study in 2026. GSK's Zacks Rank & Stock to Consider GSK currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Exelixis EXEL, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have rallied 30.2%. Story Continues EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%. 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 Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Mirum Pharmaceuticals, Inc. (MIRM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research View Comments |
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| 23.04.25 14:01:06 | Analysts Estimate GSK (GSK) to Report a Decline in Earnings: What to Look Out for | |
| The market expects GSK (GSK) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on April 30. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. Zacks Consensus Estimate This drug developer is expected to post quarterly earnings of $1.08 per share in its upcoming report, which represents a year-over-year change of -0.9%. Revenues are expected to be $9.54 billion, up 2.2% from the year-ago quarter. Estimate Revisions Trend The consensus EPS estimate for the quarter has been revised 1.86% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Earnings Whisper Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Story Continues Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). How Have the Numbers Shaped Up for Glaxo? For Glaxo, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -0.93%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Glaxo will beat the consensus EPS estimate. Does Earnings Surprise History Hold Any Clue? While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Glaxo would post earnings of $0.53 per share when it actually produced earnings of $0.59, delivering a surprise of +11.32%. Over the last four quarters, the company has beaten consensus EPS estimates four times. Bottom Line An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Glaxo doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. An Industry Player's Expected Results Among the stocks in the Zacks Medical - Biomedical and Genetics industry, NeoGenomics (NEO) is soon expected to post loss of $0.02 per share for the quarter ended March 2025. This estimate indicates no change from the year-ago quarter. This quarter's revenue is expected to be $170.88 million, up 9.4% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for NeoGenomics has remained unchanged. Nevertheless, the company now has an Earnings ESP of -7.70%, reflecting a lower Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #4 (Sell), makes it difficult to conclusively predict that NeoGenomics will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. 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 NeoGenomics, Inc. (NEO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research View Comments |
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| 17.04.25 19:31:10 | US Advisory Panel Votes To Expand Recommendation For Pfizer, GSK's RSV Vaccines For Older Adults Below 60 Years | |
| 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 respiratory tract disease (LRTD). In June 2024, ACIP postponed a vote on a recommendation for adults aged 50-59 at increased risk for RSV-LRTD until additional data becomes available. The update includes Pfizer Inc.’s (NYSE:PFE) 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 risk of severe disease. Also Read: Trump’s New Order Targets Drug Pricing Transparency And Medicare Cost Reduction The recommendation also includes GSK plc’s (NYSE:GSK) Arexvy in adults aged 50-59 who are at increased risk for severe RSV disease. This expands on ACIP’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 – 20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50 – 59 years. 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’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’s RSV vaccine. The updated recommendation does not benefit Moderna Inc’s (NASDAQ:MRNA) 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&D Day event and has since submitted an application to the FDA for regulatory approval using a priority review voucher. The FDA has accepted Moderna’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. Story Continues “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,” 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. Read Next: Eli Lilly’s Oral GLP-1 Drug Orforglipron Hits Phase 3 Goals In Diabetes Trial, Stock Soars Photo by pedro7merino via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? PFIZER (PFE): Free Stock Analysis Report MODERNA (MRNA): Free Stock Analysis Report GSK (GSK): Free Stock Analysis Report This article US Advisory Panel Votes To Expand Recommendation For Pfizer, GSK's RSV Vaccines For Older Adults Below 60 Years originally appeared on Benzinga.com © 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. View Comments |
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| 17.04.25 18:10:35 | UK Becomes First Country To Authorize Blenrep In Two Combo Regimens | |
| The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday authorized GSK plc’s (NYSE:GSK) Blenrep. Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. This U.K. regulatory authorization marks the first in the world for Blenrep in this treatment setting. Also Read: FDA Approves GSK’s Oral Antibiotic For Urinary Tract Infections For Females Aged 12 Years And Older Efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma support MHRA authorization of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7. DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma. In DREAMM-7, the Blenrep combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively. DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months, favoring the Blenrep combination (n=243) versus the daratumumab-based comparator (n=251). The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the Blenrep combination compared to 12.7 months in the bortezomib combination. Blenrep combinations are currently under review in 14 countries, including the U.S., with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025. In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. Price Action: GSK stock is up 1.74% at $35.99 at the last check Thursday. Story Continues Read Next: Lockheed Martin Confirms New CFO, Evan Scott Takes Over For Jesus ‘Jay’ Malave Photo by HJBC via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? GSK (GSK): Free Stock Analysis Report This article UK Becomes First Country To Authorize Blenrep In Two Combo Regimens originally appeared on Benzinga.com © 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved. View Comments |
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| 17.04.25 12:00:00 | Alector Announces Completion of Enrollment in the PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Individuals with Early Alzheimer’s Disease | |
| Alector, Inc. --76-week trial is evaluating the safety and efficacy of a progranulin-elevating candidate in slowing disease progression-- --Enrollment completed ahead of schedule-- SOUTH SAN FRANCISCO, Calif., April 17, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced the completion of enrollment in PROGRESS-AD, a 76-week Phase 2 clinical trial evaluating the safety and efficacy of AL101/GSK4527226 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Alector and GSK are co-developing AL101, an investigational human monoclonal antibody designed to block and downregulate the sortilin receptor to elevate progranulin (PGRN) levels in the brain. Modest reductions in PGRN levels due to GRN gene mutations have been shown to be associated with an increased risk of developing AD.1, 2, 3 Conversely, elevated PGRN levels have been shown to be protective in animal models of AD.4 “In partnership with GSK, we are pleased to announce the completion of enrollment ahead of schedule in the PROGRESS-AD Phase 2 clinical trial of AL101, marking an important milestone in our pursuit of developing first-in-class therapies for Alzheimer’s disease,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “This achievement brings us one step closer to assessing the potential of AL101 in slowing disease progression and to furthering our understanding of AL101’s effects on individuals living with this devastating condition. We remain committed to advancing our progranulin-elevating candidate and evaluating its impact in the ongoing trial.” PROGRESS-AD is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of AL101, which GSK is conducting at multiple sites globally. Two dose levels of AL101 are being evaluated in the trial, with participants randomized to receive either AL101 or placebo intravenously. The primary endpoint of the study is disease progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR®-SB). The CDR-SB is a validated instrument that tracks the progression of cognitive impairments in various categories. The trial also measures other clinical and functional outcome assessments. Additional information about PROGRESS-AD (NCT06079190) may be found at ClinicalTrials.gov. About AL101/GSK4527226 AL101/GSK4527226 is an investigational human monoclonal antibody designed to block and downregulate the sortilin receptor to elevate progranulin (PGRN) levels in the brain. PGRN, a protein encoded by the GRN gene, regulates lysosomal function, neuronal survival, and inflammation. The protein is genetically linked to multiple neurodegenerative disorders. Alector and GSK are co-developing AL101 for the potential treatment of early Alzheimer’s disease (AD), and it may also be evaluated for other indications, including Parkinson’s disease (PD). Given PGRN's genetic association with neurodegeneration, elevating PGRN levels may provide a potential therapeutic approach that offers broad neuroprotection in both AD and PD. Story Continues Collaboration with GSK In July 2021, Alector entered into a collaboration and license agreement with GSK (LSE/NYSE: GSK) to collaborate on the global development and commercialization of progranulin-elevating monoclonal antibodies, including latozinemab and AL101/GSK4527226. Under the terms of the GSK agreement, Alector received $700 million in upfront payments. In addition, Alector may be eligible to receive up to an additional $1.5 billion in clinical development, regulatory, and commercial launch-related milestone payments. In the United States, the companies will equally share profits and losses from commercialization of latozinemab and AL101. Outside of the United States, Alector will be eligible for double-digit tiered royalties. About Alector Alector is a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegenerative diseases. Leveraging the principles of genetics, immunology, and neuroscience, the company is advancing a portfolio of genetically validated programs that aim to remove toxic proteins, replace deficient proteins, and restore immune and nerve cell function. Supported by biomarkers, Alector’s product candidates seek to treat a range of indications, such as frontotemporal dementia, Alzheimer’s disease, and Parkinson's disease. The company is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its next-generation product candidates and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, product candidates, blood-brain barrier technology platform, research and preclinical pipeline, planned and ongoing preclinical studies and clinical trials, anticipated timing of PROGRESS-AD, expected milestones, expectations of our collaboration with GSK, expectations of our interactions with regulatory authorities, and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Annual Report on Form 10-K filed for 2024, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law. REFERENCES Bellenguez, C., et al. New insights into the genetic etiology of Alzheimer’s disease and related dementias. Nat. Genet. 2022, 54, 412–436. Brouwers, N, et al. Genetic variability in progranulin contributes to risk for clinically diagnosed Alzheimer disease. Neurology. 2008, 71, 656–664. Fenoglio, C, et al. Rs5848 variant influences GRN mRNA levels in brain and peripheral mononuclear cells in patients with Alzheimer’s disease. J.Alzheimer’s Dis. 2009, 18, 603–612 Minami, S.S; et al. Progranulin protects against amyloid beta deposition and toxicity in Alzheimer’s disease mouse models. Nat. Med. 2014, 20, 1157–1164. Alector Contacts: Alector Katie Hogan 202-549-0557 katie.hogan@alector.com Argot Partners (media) David Rosen 646-461-6387 alector@argotpartners.com Argot Partners (investors) Laura Perry 212-600-1902 alector@argotpartners.com View Comments |
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| 16.04.25 21:36:00 | AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunizati | |
| Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization1 RSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US2 PHILADELPHIA, April 16, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of RSV vaccines including GSK’s AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care3. This expands on ACIP’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 lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.2 Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions.4,5 RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.5 Tony Wood, Chief Scientific Officer, GSK: "We are pleased with ACIP's recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination." In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]6 evaluating the immune response and safety of GSK’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’s RSV vaccine. The ACIP recommendations will be forwarded for review and approval. Once approved, the final recommendations will be published to advise healthcare providers on appropriate use of the vaccine and to inform insurance coverage. Story Continues About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant. The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 61 countries, including Europe, Japan and US. In addition, it is approved in the US, EU/EEA countries and Japan for use in individuals aged 50-59 who are at increased risk for lower respiratory disease caused by RSV due to certain underlying medical conditions. Regulatory reviews for this extended indication are ongoing in other countries. The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus. Indication for AREXVY AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: Individuals 60 years of age and older; Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. Important Safety Information for AREXVY AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%) In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%) There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age Vaccination with AREXVY may not result in protection of all vaccine recipients Please see full Prescribing Information for AREXVY. About RSV in adults RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.5 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.5 Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older7 and 42,000* in adults aged 50-64 years old in the US.2 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK’s Annual Report on Form 20-F for 2024. Registered in England & Wales: No. 3888792 Registered Office: 79 New Oxford Street London WC1A 1DG References __________________________________ * adjusted for under-detection 1 Horn et al, "Disparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States", Abstract presented at National Foundation for Infectious Diseases – 27 Annual Conference on Vaccinology Research – NFID 2024; May 8-10, 2024 2 McLaughlin JM et al, "Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis" in Open Forum Infectious Diseases, Volume 9, Issue 7, July 2022 3 Centers for Disease Control and Prevention (CDC), RSV vaccine guidance for older adults, August 2024. Available at: https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html (Accessed April 2025) 4 Branche AR et al., "Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020" in Clinical Infectious Diseases, 2022:74:1004–1011 5 Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: https://www.cdc.gov/rsv/older-adults/index.html - accessed in April 2025 6 M. Ferguson, "Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to ≥60 Years of Age" in Clinical Infectious Diseases, 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364. 7 Falsey, AR et al. "Respiratory syncytial virus infection in elderly and high-risk adults", in New Engl J Med 2005; 352:1749-59 View source version on businesswire.com: https://www.businesswire.com/news/home/20250415426978/en/ Contacts GSK enquiries Media: Tim Foley +44 (0) 20 8047 5502 (London) Simon Moore +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Constantin Fest +44 (0) 7831 826525 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia) View Comments |
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| 16.04.25 20:57:00 | GSK’s 5-in-1 Meningococcal Vaccine PENMENVY Receives Positive Recommendation from US Advisory Committee on Immunization Practices | |
| Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults Vaccine doses will be ready for use in the US from Summer 2025 PHILADELPHIA, April 16, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations. ACIP voted to recommend that persons over 10 years old receive a single dose of PENMENVY as an alternative to separate administration of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W, and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunization rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations.1 GSK’s MenABCWY vaccine combines the antigenic components of the Company’s two well-established meningococcal vaccines—BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). On February 14, 2025, the US Food and Drug Administration (FDA) approved GSK’s MenABCWY vaccine for use in individuals aged 10 through 25 years.2 Tony Wood, Chief Scientific Officer at GSK, said: "We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunization rates among adolescents and young adults in the US, who are at an age with increased risk." Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.3,4 Three of every four MenB doses currently administered in the US are manufactured by GSK,5 positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer’s MenB vaccine.6 Story Continues About IMD IMD is an uncommon but serious illness that can lead to death for up to one in ten of those who contract it in as little as 24 hours from onset, despite treatment.7 IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.7,8 Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.8 Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD, such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.9,10 About PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). In the US, PENMENVY is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 through 25 years. The FDA-approved dosing is to administer two doses six months apart. The US Prescribing Information is available here.11 Important Safety Information for PENMENVY in the US The following is based on the US Prescribing Information for PENMENVY. Please consult the full Prescribing Information for additional safety information. Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of PENMENVY PENMENVY may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Immunocompromised persons, including those receiving immunosuppressive therapy, may have reduced immune responses to PENMENVY Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis, including disease caused by serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of a U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENMENVY to persons with a history of GBS should take into account the expected benefits and potential risks The most commonly reported solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2: pain at the injection site, fatigue, headache, myalgia, nausea, erythema, and swelling. The most commonly reported solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2: pain at the injection site, headache, fatigue, myalgia, and nausea About BEXSERO (Meningococcal Group B Vaccine) GSK’s MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunization programs worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. More than 110 million doses have been distributed worldwide since 2015.12 Clinical data supported its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterized safety profile. In the US, BEXSERO is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years. The US Prescribing Information is available here.13 Important Safety Information for BEXSERO in the US The following is based on the US Prescribing Information for BEXSERO. Please consult the full Prescribing Information for additional safety information. Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions Syncope (fainting) can occur in association with administration of BEXSERO BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even after being vaccinated with BEXSERO The most commonly reported solicited adverse reactions: pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling About MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.14 It offers evidence of immunogenicity with a well-characterized safety profile. In the US, MENVEO is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here.15 Important Safety Information for MENVEO in the US The following is based on the US Prescribing Information for MENVEO. Please consult the full Prescribing Information for additional safety information. Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of MENVEO Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even after being vaccinated with MENVEO Guillain-Barré syndrome has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine Apnea following intramuscular vaccination has been observed in some infants born prematurely Common solicited adverse reactions: at 2 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age - injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Among adolescents and adults aged 11 through 55 years were pain at the injection site, headache, myalgia, malaise, and nausea - similar rates were observed following a booster dose In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation Vaccination with MENVEO may not result in protection in all vaccine recipients About GSK GSK is a global biopharma Company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK’s Annual Report on Form 20-F for 2024. Registered in England & Wales: No. 3888792 Registered Office: 79 New Oxford Street London WC1A 1DG References: Centers for Disease Control and Prevention. About Meningococcal Vaccines. Available at: https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html. Accessed April 2025. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Available at: https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/. Accessed April 2025. Cheng WY, et al. Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations. Hum Vaccin Immunother. 2020;16(1):176-188. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023. Available at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388. Accessed April 2025. GSK Data on File Calculation of GSK share in US MenB market January – December 2024. REF-269547. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html. Accessed April 2025. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403. Marshall GS, et al. Understanding the Sequelae of Invasive Meningococcal Disease in the United States. Infect Dis Ther. 2024;13(11):2213-2220. European Centers for Disease Control and Prevention. Outbreak of invasive meningococcal disease in the EU associated with a mass gathering event, the 23rd World Scout Jamboree, in Japan. 21 August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf. Accessed April 2025. Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/risk-factors/index.html. Accessed April 2025. GSK. US Prescribing Information for Penmenvy. Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF. Accessed April 2025. GSK Data on File. Number of Bexsero doses shipped from 2015 to November 2023 REF-219766 GSK. US Prescribing Information for Bexsero. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF. Accessed April 2025. GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022 REF-195452. GSK. Prescribing Information for Menveo. Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF. Accessed April 2025. View source version on businesswire.com: https://www.businesswire.com/news/home/20250416715903/en/ Contacts GSK enquiries Media: Tim Foley +44 (0) 20 8047 5502 (London) Simon Moore +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Alison Hunt +1 540 742 3391 (Washington DC) Investor Relations: Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Camilla Campbell +44 (0) 7803 050238 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia) View Comments |
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| 10.04.25 00:04:35 | GSK (LSE:GSK) Sees 6% Share Price Decline Over The Last Quarter | |
| GSK recently announced the FDA approval of Blujepa, a first-in-class antibiotic for urinary tract infections, and the EMA's acceptance of an application for Nucala's expanded use. Despite these positive developments, the company's share price experienced a 6% decline over the last quarter. This movement occurred amid broader market volatility, where major indices faced notable declines, though recently improved following a pause on tariffs. GSK's earnings report revealed a decline in net income, which might have weighed on investor sentiment, overshadowing the impact of new product approvals and regulatory progress. We've discovered 4 possible red flags for GSK that you should be aware of before investing here.LSE:GSK Revenue & Expenses Breakdown as at Apr 2025 AI is about to change healthcare. These 26 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. The recent FDA approval for Blujepa and EMA's acceptance of the expanded use application for Nucala could signal significant future potential for GSK's revenue and earnings. With these approvals, the company may strengthen its portfolio, enhancing investor confidence in projected future growth. In the longer-term context, GSK's total shareholder return, including dividends and share price movement, experienced a marginal 0.05% decline over the past five years. This performance indicates challenges in maintaining positive returns, despite positive developments, such as those recently announced. Comparatively, GSK underperformed the UK market's 3% decline and the UK Pharmaceuticals industry's 4.8% dip over the last year, highlighting industry-wide pressures. Analysts forecast revenue growth, but recent underperformance suggests potential risks in aligning with optimistic estimates. The analyst consensus price target of £17.08, which is 16.1% higher than the current share price of £14.34, suggests room for upside if upcoming product approvals and market conditions materialize as expected. Investors should consider these factors in relation to the company's current valuation and future expectations. Explore GSK's analyst forecasts in our growth report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Story Continues Companies discussed in this article include LSE:GSK. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com View Comments |
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