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Theravance Inc (THRX.O)

THRX.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

GSK files EU submission for closed triple combination therapy for patients with COPD
Friday, 2 Dec 2016 10:12am EST 

Innoviva Inc - : GSK files regulatory submission in European union for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD . Regulatory submissions of closed triple therapy for COPD are anticipated in rest of world beginning in 2017 .EU regulatory submission comprises marketing authorisation application for maintenance treatment to relieve symptoms of adult patients with COPD.  Full Article

GSK files regulatory submission in US for once-daily closed triple combination therapy ff/umec/vi for patients with COPD
Monday, 21 Nov 2016 07:00am EST 

Glaxosmithkline Plc :GSK files regulatory submission in us for once-daily closed triple combination therapy ff/umec/vi for patients with copd.  Full Article

GSK presents positive results from phase III FULFIL study
Tuesday, 6 Sep 2016 09:45am EDT 

GlaxoSmithKline Plc : Gsk presents positive results from phase iii fulfil study of closed triple combination therapy ff/umec/vi versus symbicort® turbohaler® in copd at ers international congress . Study which reported headline results in june 2016, met its two co-primary endpoints .Plans are on schedule for regulatory submissions of closed triple combination therapy for copd in us and europe by end of 2016.  Full Article

Innoviva Q2 adjusted cash earnings per share $0.17
Thursday, 28 Jul 2016 04:05pm EDT 

Innoviva Inc : Qtrly total revenue $32.5 million versus $10.7 million . Innoviva reports second quarter 2016 financial results . Q2 adjusted cash earnings per share $0.17 . Q2 earnings per share $0.13 .Q2 earnings per share view $0.11 -- Thomson Reuters I/B/E/S.  Full Article

GlaxoSmithKline says lung drug meets late-stage study goals
Monday, 20 Jun 2016 02:02am EDT 

Glaxosmithkline Plc : Fulfil study results closed triple eu . Fulfil study shows superiority of closed triple combination therapy ff/umec/vi versus symbicort turbohaler . Data supports regulatory submission by gsk in europe by end of 2016 . Positive top-line results from phase iii study of fluticasone furoate/umeclidinium/vilanterol . Study met its two co-primary endpoints .Study demonstrated statistically significant improvements in lung function and health- related quality of life.  Full Article

Glaxosmithkline and Innoviva report positive headline results in Salford Lung study
Tuesday, 24 May 2016 05:54am EDT 

Glaxosmithkline Plc : Co and Innoviva announced positive headline results from innovative salford lung study in chronic obstructive pulmonary disease . Study showed that relvar ® ellipta ® 100/25mcg achieved a superior reduction in exacerbations versus usual care, in patients with copd . Analyses remain ongoing and will be subject of future publications and presentations . Second salford lung study is currently being conducted in asthma patients, with results expected in 2017 .For primary effectiveness analysis, in patients treated there was statistically significant reduction in rate of moderate or severe exacerbations.  Full Article

Theravance Inc declares cash dividend
Wednesday, 29 Jul 2015 04:05pm EDT 

Theravance Inc:Declared $0.25 per share cash dividend to be paid on Sept. 30, to stockholders of record as of close of business on Sept. 10.  Full Article

Glaxosmithkline plc and Theravance announces FDA approval of BREO ELLIPTA for treatment of adults with asthma in the US
Thursday, 30 Apr 2015 03:17pm EDT 

Glaxosmithkline plc and Theravance:Says that the US Food and Drug Administration (FDA) has approved BREO ELLIPTA (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older.Breo Ellipta is not indicated for the relief of acute bronchospasm.Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI).Says two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.FDA issued a complete response letter related to the proposed use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients.FDA stated that additional data would be required to further demonstrate the safety and efficacy in this population.  Full Article

Theravance Inc announces cash dividend
Monday, 23 Feb 2015 04:05pm EST 

Theravance Inc:Declares a $0.25 per share cash dividend to be paid on March 31 to stockholders of record as of the close of business on March 12.  Full Article

GlaxosmithKline Plc and Theravance Inc announce start of Phase III lung function study with 'closed' triple combination treatment FF/UMEC/VI for COPD
Monday, 9 Feb 2015 05:12am EST 

GlaxosmithKline Plc and Theravance Inc:Says start of second global phase III study.To evaluate effects of investigational once-daily closed triple combination of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with chronic obstructive pulmonary disease (COPD).Secondary objectives include investigating effect on rate of exacerbations with FF/UMEC/VI compared with budesonide/formoterol, and the safety profile of FF/UMEC/VI compared with budesonide/formoterol.Adverse events of particular interest include pneumonia and cardiovascular risk. Patient perspectives of efficacy and physical activity will also be evaluated versus budesonide/formoterol.First, larger study in phase III programme, known as IMPACT, started in July 2014.To assess whether FF/UMEC/VI can reduce rate of moderate and severe exacerbations compared with two approved once-daily COPD treatments, Relvar/Breo Ellipta, an ICS/LABA combination, and Anoro Ellipta, LAMA/LABA combination.  Full Article