Welcome to our dedicated page for GSK PLC news (Ticker: GSK), a resource for investors and traders seeking the latest updates and insights on GSK PLC stock.
News and regulatory disclosures for GSK plc (GSK) highlight the company’s ongoing activity across medicines, vaccines and strategic collaborations. As a global biopharma company, GSK regularly reports clinical trial milestones, product approvals, public health initiatives and agreements with partners and governments.
Recent news includes multiple regulatory approvals and data readouts in respiratory medicine. GSK has announced approvals for Exdensur (depemokimab) in markets such as Japan for severe asthma and chronic rhinosinusitis with nasal polyps, based on the SWIFT and ANCHOR phase III trials. The company has also reported that Nucala (mepolizumab) was approved in China as an add-on maintenance treatment for adults with COPD characterized by raised blood eosinophils, supported by the MATINEE and METREX studies.
In vaccines, GSK issues updates on Shingrix, including US FDA and European Commission approvals of a prefilled syringe presentation designed to simplify administration, and on its seasonal influenza vaccines FLULAVAL and FLUARIX, which are shipped ahead of each US flu season following FDA lot-release. News about Vaccine Track, GSK’s public data tool for US adult immunization trends, provides additional context on the company’s role in vaccination and public health analytics.
Oncology and specialty medicine updates feature prominently in GSK news. The company has reported US FDA approval of Blenrep in combination regimens for relapsed or refractory multiple myeloma, as well as positive phase III results for bepirovirsen in chronic hepatitis B with plans for global regulatory submissions. Additional releases describe collaborations with partners such as Hengrui Pharma and Summit Therapeutics to develop new respiratory, immunology & inflammation and oncology programs.
Investors and observers following GSK news can expect coverage of clinical trial outcomes, regulatory decisions, pricing and access agreements, and community initiatives such as the Linked by Lupus: Optimal Care Initiative. Bookmarking this page provides a centralized view of GSK’s latest announcements and SEC-reported developments.
908 Devices (NASDAQ: MASS) announced that GlaxoSmithKline (NYSE: GSK) has acquired an additional REBEL™ cell culture media analyzer, bringing GSK's total to five units. This device aids in optimizing cell cultures rapidly and is compatible with bioreactor setups. 908 Devices reported that there are now 15 customers with multiple REBEL devices, a significant increase year-over-year. All top 20 pharmaceutical companies are utilizing 908 Devices' products, enhancing their development processes.
ViiV Healthcare has received FDA approval for Apretude, a long-acting injectable HIV pre-exposure prophylaxis (PrEP), the first of its kind to show superior efficacy compared to daily oral options. It is indicated for adults and adolescents over 35 kg at risk of HIV. Apretude can be administered as few as six times a year, with studies showing a 69% to 90% lower incidence of HIV compared to daily oral options. This innovative treatment addresses the needs of vulnerable populations, particularly in Black and Latinx communities, providing an alternative to daily pills.
ViiV Healthcare has released survey data for World AIDS Day, revealing significant stigma and misinformation about HIV. Conducted by The Harris Poll among 5,047 adults in the U.S., UK, Australia, and Portugal, the survey found that 88% of respondents perceive ongoing negative attitudes towards individuals living with HIV. It also highlighted that 76% were unaware that effective treatment can prevent HIV transmission. ViiV emphasizes the need for ongoing anti-stigma campaigns, showcasing collaborative efforts like HIV in View.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) has finalized an exclusive license agreement with GlaxoSmithKline (LSE/NYSE: GSK) for ARO-HSD, a therapeutic for nonalcoholic steatohepatitis (NASH). Arrowhead will receive a $120 million upfront payment and could earn up to $1.1 billion in additional milestone payments and royalties. The agreement allows GSK to develop ARO-HSD globally, except in Greater China, where Arrowhead retains rights. The transaction is expected to close in Q1 2022, pending customary conditions.
On November 17, 2021, GSK's Robitussin announced a partnership with All Stars Project, Inc. to enhance access to performing arts education for underserved youth. Committing $50,000, Robitussin aims to bridge educational inequities highlighted by the National Center for Education Statistics. Additionally, they will collaborate with Tony Award-winning actress Adrienne Warren to elevate young voices. On November 30, an Instagram Live event will further promote the initiative. The company also partnered with Good360 to donate cough care products to those in need, emphasizing its commitment to equitable health solutions.
GlaxoSmithKline (GSK) has announced a partnership with comedian Ronny Chieng for Thanksgiving, offering consumers holiday hacks through TUMS®, the leading heartburn relief brand. From November 23-25, Chieng will answer consumer queries on Twitter, addressing common holiday dilemmas like cooking mishaps. This initiative is part of TUMS®' ongoing efforts to ensure celebratory gatherings are enjoyable despite potential heartburn. TUMS® continues to be the most recommended adult antacid brand, providing quick relief for heartburn and related symptoms.
GlaxoSmithKline plc (GSK) announced positive Phase III results for daprodustat, an oral treatment for anaemia in chronic kidney disease (CKD), at the American Society of Nephrology's Kidney Week 2021. The ASCEND programme, involving over 8,000 patients, demonstrated daprodustat's efficacy and safety, achieving non-inferiority in cardiovascular risk compared to standard treatment. Primary efficacy endpoints were met in both ASCEND-ND and ASCEND-D studies, with improvements in haemoglobin levels. Daprodustat is currently approved in Japan and will support global regulatory filings.
ViiV Healthcare, majority-owned by GSK and partnered with Pfizer, has received approval from the European Commission to update product guidelines for Vocabria and Rekambys. This allows HIV patients the option to start treatment directly with injections, bypassing the oral lead-in phase. The change aims to simplify the treatment initiation process, as both methods have shown similar efficacy and safety. This decision is based on positive phase III clinical trial results that support the new regimen.
ViiV Healthcare announced positive interim results from the CARISEL study evaluating a long-acting HIV treatment regimen of Vocabria (cabotegravir) and Rekambys (rilpivirine). Conducted during the COVID-19 pandemic, the study showed 97% of participants found the bi-monthly injection visits acceptable. Healthcare teams across five European countries largely agreed on the regimen's feasibility, with mean scores of 4.6 for acceptability. Additionally, implementation concerns among healthcare teams decreased significantly over time, indicating strong potential for this innovative treatment in diverse settings.
GSK Consumer Healthcare's Theraflu brand launched the Rest & Recover Fund to address barriers to sick time access and cultural stigma. A survey, the 2021 Temperature Check Report, showed that nearly 70% of working Americans have gone to work sick due to financial constraints. The fund, in partnership with Good+Foundation, aims to distribute microgrants to assist with lost wages from unpaid sick days, particularly benefiting Black and Latina mothers. Findings reveal that 58% of Americans avoid sick days for fear of reprimand, highlighting significant disparities in sick leave access and social pressures.