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GlaxoSmithKline PLC (GSK.L)

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Latest Key Developments (Source: Significant Developments)

GSK says Shingrix phase 3 study met main goal
Wednesday, 21 Jun 2017 09:13am EDT 

June 21 (Reuters) - Glaxosmithkline Plc ::Presents positive results from phase III revaccination study of its candidate shingles vaccine Shingrix at CDC's advisory meeting.Study met its primary objective of demonstrating non-inferior immune response.Shingrix was well-tolerated in both study groups when assessed up to one month after second dose of Shingrix.  Full Article

GlaxoSmithKline announces positive results from two phase III studies of Tafenoquine​
Monday, 12 Jun 2017 07:09am EDT 

June 12 (Reuters) - GlaxoSmithKline Plc :‍GSK and Medicines for Malaria Venture announced positive results from two phase III studies of Tafenoquine​.Tafenoquine is an investigational 8-aminoquinoline, for prevention of relapse of plasmodium vivax (p.vivax) malaria​.Headline results show single-dose of 300mg tafenoquine reduced risk of relapse in patients with p.vivax malaria​.‍Study met its primary endpoint.‍study showed that a statistically significant greater proportion of patients treated with tafenoquine (60%) remained relapse-free over 6-month follow-up period​.‍GSK plans to progress regulatory filings for prevention of relapse of p. Vivax malaria later in 2017​.  Full Article

GSK says ViiV Healthcare submits 2-drug HIV regimen application to EMA,U.S. FDA
Friday, 2 Jun 2017 02:00am EDT 

June 2 (Reuters) - Glaxosmithkline Plc ::ViiV submits first 2-drug hiv regimen application.‍Priority review voucher submitted in US with anticipated target action date of 6 months​.‍EU and US submissions for single tablet combining dolutegravir and rilpivirine​.‍$130 million cost of voucher will be reported as an research and development expense in GSK's q2 2017 adjusted results​.Under prescription drug user fee act, anticipated target action date is six months after receipt of application by FDA.Use of dolutegravir and rilpivirine as a two-drug regimen for hiv-1 maintenance therapy is investigational and not approved anywhere in world.  Full Article

Adaptimmune Therapeutics says initiated study of NY-ESO SPEAR T‑cells
Thursday, 25 May 2017 08:00am EDT 

May 25 (Reuters) - Adaptimmune Therapeutics Plc :Adaptimmune Therapeutics Plc - initiated study of NY-ESO SPEAR T‑cells targeting NY-ESO in combination with keytruda in patients with multiple myeloma.Adaptimmune Therapeutics Plc - Adaptimmune is developing NY-ESO SPEAR T-cell program under a strategic collaboration agreement with GSK.  Full Article

Kuehne und Nagel and GlaxoSmithKline expand partnership with new UK domestic distribution contract
Wednesday, 17 May 2017 11:37am EDT 


Paulson & Co Inc takes share stake in Amazon, Arconic - SEC filing
Monday, 15 May 2017 05:33pm EDT 

May 15 (Reuters) - Paulson & Co Inc : :Paulson & Co Inc takes share stake in Amazon of 5,500 shares - SEC filing.Paulson & Co Inc takes share stake of 983,300 shares in Arconic Inc.Paulson & Co Inc takes share stake of 78,101 shares in Sarepta Therapeutics Inc.Paulson & Co Inc ups share stake in Glaxosmithkline PLC by 40.2 percent to 415,100 Sponsored ADR.Paulson & Co Inc - Change in holdings are as of March 31, 2017 and compared with the previous quarter ended as of Dec 31, 2016.  Full Article

Ionis Pharma announces Phase 3 NEURO-TTR study of inotersen meets both primary endpoints
Monday, 15 May 2017 07:00am EDT 

May 15 (Reuters) - Ionis Pharmaceuticals Inc :Ionis pharmaceuticals announces phase 3 neuro-ttr study of inotersen (ionis-ttr rx) meets both primary endpoints.Says statistically significant differences were also observed for both endpoints at eight months.Ionis pharmaceuticals - long-term safety and efficacy data with inotersen currently being collected in open-label extension of phase 3 neuro-ttr study.Says review of full data package from neuro-ttr study by ionis and gsk is ongoing.Says preparation of regulatory marketing applications for inotersen is underway.Ionis pharmaceuticals - gsk has option to license inotersen following review of additional data and prior to submission of regulatory applications.  Full Article

GlaxoSmithKline announces positive results for asthma drug study
Friday, 5 May 2017 07:38am EDT 

May 5 (Reuters) - Glaxosmithkline Plc ::Announced positive results from innovative Salford Lung Study (SLS) in asthma.Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care.Study showed significantly more asthma patients initiated on treatment with Relvar Ellipta achieved improvement in their asthma control.At 24 weeks a significantly higher percentage of patients with asthma achieved better control of their asthma (71 pct) measured by asthma control test (ACT).Statistically significant findings were also seen at 12, 40 and 52 weeks.Serious adverse events of pneumonia by randomised group were reported by 39 patients (ff/vi arm 23, 1 pct; usual care arm 16, <1 pct).  Full Article

Epizyme Earns $10 million milestone payment from Glaxosmithkline
Thursday, 4 May 2017 06:30am EDT 

May 4 (Reuters) - Epizyme Inc : :Epizyme earns $10 million milestone payment from glaxosmithkline for initiation of GLP Toxicology studies with novel methyltransferase inhibitor.Epizyme - milestone payment follows GSK'S initiation of GLP toxicology studies for methyltransferase inhibitor discovered by co, licensed to GSK.  Full Article

Bluebird Bio enters into patent license agreement with Glaxosmithkline for commercialization of Gene Therapies
Tuesday, 2 May 2017 08:00am EDT 

May 2 (Reuters) - Bluebird Bio Inc :Bluebird bio enters lentiviral vector patent license agreement with Glaxosmithkline for commercialization of gene therapies.Bluebird bio - under terms of agreement, gsk will non-exclusively license certain bluebird patent rights related to lentiviral vector technology.Bluebird bio- financial terms of agreement include an upfront payment to bluebird as well as potential development and regulatory milestone payments.Bluebird bio inc - financial terms of agreement also include low single digit royalties on net sales of covered products.  Full Article

BRIEF-GSK and Innoviva submit EU filing for extended use of Relvar Ellipta

* GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination Source text for Eikon: Further company coverage: