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Pin to quick picksGlaxosmithkline Share News (GSK)

Share Price Information for Glaxosmithkline (GSK)

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Share Price: 1,733.50
Bid: 1,732.50
Ask: 1,733.00
Change: 5.00 (0.29%)
Spread: 0.50 (0.029%)
Open: 1,733.00
High: 1,739.50
Low: 1,724.50
Prev. Close: 1,728.50
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GlaxoSmithKline's COPD biologic rejected by FDA advisory board

Thu, 26th Jul 2018 08:16

(Sharecast News) - GlaxoSmithKline's application to market a new biologic drug for chronic obstructive pulmonary disease has been rejected by the advisory board of the US medical watchdog, though the company remains confident in the drug as a COPD treatment. GSK said it would continue to work with the US Food & Drug Administration to address outstanding questions after the regulator's pulmonary allergy drugs advisory committee voted 16-3 against approving the use of mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD.The committee voted on the basis of data presented that the risk-benefit profile of mepolizumab was not adequate to support approval and also voted 16-3 that there was not substantial evidence of the efficacy of the treatment.One positive was that the committee suggested further data to characterise the patient population that would be most likely to benefit from this targeted biologic therapy after voting 17-2 that there was adequate evidence of the safety of the drug.As FDA advisory committees recommendations are non-binding, GSK is still working towards a 7 September goal date for approval as a prescription drug.GSK's respiratory research and development chief, Dave Allen, said: "Having participated in today's advisory committee meeting and heard the recommendation we will continue to work with the FDA to address outstanding questions. We remain confident our data supports mepolizumab as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count."Mepolizumab has been approved under the brand name Nucala in over 20 other markets as an add-on maintenance treatment for patients with severe eosinophilic asthma, and in the US, Canada and Japan as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis, but is not currently approved for use in COPD anywhere in the world. No biologic therapies have yet been approved for COPD sufferers.GSK shares fell 2% to 1,510p on Thursday morning.Analysts at Shore Capital said the submission was based on data from the METREX and METREO trials which produced mixed results: "Namely, in patients with high blood eosinophil count in METREX, there was a statistically significant effect for Nucala, but in Metreo (which enrolled only high blood eosinophil patients), the effect size didn't reach statistical significance, although the point estimates for a 100mg dose of the drug in both trials was fairly consistent."Notably, in METREO, a 300mg dose had a weaker effect size vs. a 100mg dose, which may have warranted further questions from the regulator."
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PRESS: AJ Bell founder to join Applied Nutrition ahead of IPO - Sky

(Alliance News) - Supplements maker Applied Nutrition, plotting a London stock market float, is to add AJ Bell PLC founder Andy Bell as its chair, Sky News reported on Tuesday.

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20 Feb 2024 08:55

IN BRIEF: Diageo welcomes GSK's CFO as non-executive director

Diageo PLC - London-based brewer and distiller sells more than 200 drinks brands, including Guinness stout, Captain Morgan rum and Johnnie Walker whisky - Appoints GSK PLC's chief financial officer and executive director, Julie Brown, as a non-executive director. Says she will succeed Alan Stewart as chair of the audit committee after his retirement following the firm's annual general meeting in September. Chair Javier Ferran says: "Julie brings many years of experience in financial, commercial and strategic roles in international companies operating in highly regulated industries. She is strongly committed to enabling diversity in business and to creating sustainable, long-term value for stakeholders. I look forward to her contribution to Board discussions and to working with her in progressing Diageo's ambition to be one of the most trusted and respected consumer products companies in the world."

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15 Feb 2024 14:44

UK dividends calendar - next 7 days

Friday 16 February 
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15 Feb 2024 11:02

Berenberg hikes target price on GSK

(Sharecast News) - Analysts at Berenberg hiked their target price on drugmaker GSK from £16.50 to £18.20 on Thursday, stating the group was moving closer to offsetting losses associated with the expiry of its patent on HIV drug dolutegravir.

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15 Feb 2024 09:45

LONDON BROKER RATINGS: Jefferies cuts Kingfisher but Citi raises

(Alliance News) - The following London-listed shares received analyst recommendations Thursday morning and Wednesday:

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15 Feb 2024 08:49

GSK completes USD1.4 billion purchase of respiratory firm Aiolos Bio

(Alliance News) - GSK PLC on Thursday said it has completed the acquisition of Aiolos Bio Ltd, expanding its respiratory portfolio with a potential "best-in-class" asthma treatment.

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13 Feb 2024 16:53

LONDON MARKET CLOSE: Stocks in red amid sticky US inflation data

(Alliance News) - Stock prices in London closed in the red on Tuesday, after a key US inflation reading came in hotter-than-expected.

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13 Feb 2024 16:21

London close: Stocks fall as US inflation tops expectations

(Sharecast News) - London markets ended the trading day in negative territory on Tuesday, influenced by concerns over higher inflation figures from the United States and a deceleration in wage growth within the UK.

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13 Feb 2024 16:21

London close: Stocks fall as US inflation tops expectations

(Sharecast News) - London markets ended the trading day in negative territory on Tuesday, influenced by concerns over higher inflation figures from the United States and a deceleration in wage growth within the UK.

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13 Feb 2024 12:06

LONDON MARKET MIDDAY: Stocks fall but pound up before US data

(Alliance News) - Stock prices in London were on the decline on Tuesday afternoon, with sentiment tetchy ahead of a US inflation report later.

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13 Feb 2024 09:45

Citi ups recommendation on GSK to 'buy'

(Sharecast News) - Citi has upgraded its rating on vaccines and drugs blue chip GSK to 'buy' while also boosting its earnings estimates.

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13 Feb 2024 09:32

LONDON BROKER RATINGS: Citi lifts GSK; Shore likes XPS Pensions

(Alliance News) - The following London-listed shares received analyst recommendations Tuesday morning and Monday:

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13 Feb 2024 07:45

LONDON BRIEFING: "Record" Tui quarter; Ultimate Products eyes payouts

(Alliance News) - London's FTSE 100 is to open ever-so-slightly lower on Tuesday, with trade set to be nervy ahead of the afternoon's US inflation data.

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12 Feb 2024 17:11

London close: Stocks finish higher after very quiet Monday

(Sharecast News) - London markets managed modest gains by the close of a subdued trading session on Monday, with no significant corporate or economic catalysts driving movements.

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12 Feb 2024 12:04

LONDON MARKET MIDDAY: FTSE 100 underperforms as European peers rise

(Alliance News) - London's FTSE 100 underwhelmed on Monday, with some of its largest constituents pulling it lower, while indices in Europe were on the up on favourable comments on interest rate cuts by a European Central Bank official.

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