GSK.L - GlaxoSmithKline plc
| Previous close | 1,645.60 |
| Open | 1,651.00 |
| Bid | 1,610.00 x 0 |
| Ask | 1,670.00 x 0 |
| Day's range | 1,642.00 - 1,662.00 |
| 52-week range | 1,408.80 - 1,749.40 |
| Volume | 4,806,854 |
| Avg. volume | 8,870,136 |
| Market cap | 82.708B |
| Beta (3Y monthly) | 0.85 |
| PE ratio (TTM) | 18.67 |
| EPS (TTM) | N/A |
| Earnings date | N/A |
| Forward dividend & yield | 0.76 (4.62%) |
| Ex-dividend date | 2019-08-08 |
| 1y target est | N/A |
Business WireViiV Healthcare Submits Regulatory Application to European Medicines Agency for Investigational Cabotegravir to Be Used in Combination With Rilpivirine as the First Monthly, Injectable Treatment for HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy. Deborah Waterhouse, CEO of ViiV Healthcare, said: “ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment.
- Business Wire
ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection
Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1. Kimberly Smith, MD, Head of Global Research & Medical Strategy at ViiV Healthcare, said: “With HIV now considered a chronic condition and people living with HIV needing antiretroviral treatments for life, taking fewer medicines over a lifetime has become an important consideration for the community.
- Business Wire
ViiV Healthcare presents GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir plus lamivudine continues to demonstrate high efficacy rates and no cases of treatment emergent resistance
ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced Week 96 results from its phase III GEMINI 1 & 2 studies, which showed that the 2-drug regimen (2DR) of dolutegravir plus lamivudine continued to offer non-inferior efficacy to a 3-drug regimen of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) with no cases of treatment emergent resistance in individuals with virologic failure.1 The data were presented today at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.
- Business Wire
ViiV Healthcare presents positive 96-week data from phase III study of investigational fostemsavir in heavily treatment-experienced patients with HIV at IAS 2019
LONDON--(BUSINESSWIRE)-- ViiV Healthcare , the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive Week 96 results from ...
- Business Wire
ViiV Healthcare Announces Phase III Study Meets Primary Endpoint, Demonstrating the Ability to Control HIV-1 With the 2-drug Regimen Dovato (dolutegravir Plus Lamivudine) in Virally Suppressed Patients Switching From a TAF-containing, 3-drug Regimen
LONDON--(BUSINESSWIRE)-- ViiV Healthcare , the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive Week 48 results from ...
- Business Wire
ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection
Deborah Waterhouse, CEO, ViiV Healthcare, said: “For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based two-drug regimen development programme challenges this, and with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals. With around 25,000 new HIV diagnoses in Europe* every year2, and the fact that today HIV is considered a chronic condition which requires people living with HIV (PLHIV) to remain on antiretroviral (ARV) treatment for life, it is ever more important to provide innovative treatment options.
- Business Wire
Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate. This is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector. This approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate.
- Business Wire
Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint
LONDON--(BUSINESSWIRE)-- GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced headline results from the pivotal phase III CAPTAIN study of once-daily single inhaler triple ...
- Business Wire
US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults
LONDON--(BUSINESSWIRE)-- Approval based on GEMINI pivotal trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, traditional, three-drug regimen through 48 weeks, with ...
- Business Wire
ViiV Healthcare Presents Positive, 48-Week Data from Two Pivotal Phase III Studies Showing Long-Acting, Injectable Two-Drug Regimen of Cabotegravir and Rilpivirine Has Similar Efficacy to Daily, Three-Drug Oral Treatment in Adults Living with HIV-1 Infection
LONDON--(BUSINESSWIRE)-- Comprehensive data from ATLAS and FLAIR studies presented today at the 2019 Conference on Retroviruses and Opportunistic Infections show investigational long-acting injectable ...
- Business Wire
Pfizer and GlaxoSmithKline Announce Joint Venture to Create a Premier Global Consumer Healthcare Company
Pfizer Inc. (PFE) and GlaxoSmithKline plc (GSK) today announced they have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business.
- Business Wire
Once-daily Trelegy Ellipta gains expanded COPD indication in Europe
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the European Commission has authorised an expanded label for once-daily Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), recognising its effect on exacerbations and making it the first single inhaler triple therapy indicated for patients with moderate to severe chronic obstructive pulmonary disease (COPD) not adequately treated with dual bronchodilation or with an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA).
- Business Wire
Trelegy Ellipta Receives Positive CHMP Opinion Supporting Expanded COPD Indication in Europe
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion today supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/ vilanterol ‘FF/UMEC/VI’) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD. It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study. Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said, “Many patients with COPD continue to experience exacerbations despite taking dual bronchodilator therapies.