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GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

1,557.60GBp
19 Oct 2018
Change (% chg)

47.00 (+3.11%)
Prev Close
1,510.60
Open
1,523.20
Day's High
1,558.40
Day's Low
1,516.00
Volume
10,927,275
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52-wk High
1,634.48
52-wk Low
1,235.20

Latest Key Developments (Source: Significant Developments)

GSK Says ViiV Submits HIV 2DR Regulatory Application To U.S. FDA
Thursday, 18 Oct 2018 

Oct 18 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC - VIIV SUBMITS HIV 2DR REGULATORY APPLICATION TO FDA.GLAXOSMITHKLINE PLC - PRIORITY REVIEW VOUCHER USED WITH NDA SUBMISSION WITH ANTICIPATED TARGET ACTION DATE OF SIX MONTHS.  Full Article

EMA's PRAC Issues Precautionary Advice On HIV Medicine Dolutegravir
Friday, 5 Oct 2018 

Oct 5 (Reuters) - European Medicines Agency::EMA- PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE HAS RECOMMENDED RESTRICTING THE USE OF FLUOROQUINOLONE AND QUINOLONE ANTIBIOTICS.EMA SAYS PRAC CONFIRMS PRECAUTIONARY ADVICE ON HIV MEDICINE DOLUTEGRAVIR.EMA- RESTRICTION RECOMMENDED FOLLOWING REVIEW OF DISABLING, POTENTIALLY LONG-LASTING SIDE EFFECTS REPORTED WITH FLUOROQUINOLONE, QUINOLONE ANTIBIOTICS.EMA - SOME FLUOROQUINOLONE, QUINOLONE ANTIBIOTICS TO BE REMOVED FROM MARKET AS THEY WERE AUTHORISED FOR INFECTIONS THAT SHOULD NO LONGER BE TREATED WITH THEM.  Full Article

Orchard Rx Limited Files For U.S. IPO Of Up To $172.5 Million
Thursday, 4 Oct 2018 

Oct 4 (Reuters) - Orchard Rx Limited ::ORCHARD RX LIMITED FILES FOR U.S. IPO OF UP TO $172.5 MILLION – SEC FILING.ORCHARD RX LIMITED SAYS IT INTENDS TO APPLY TO HAVE ITS ADS LISTED ON NASDAQ GLOBAL MARKET UNDER THE SYMBOL "ORTX".ORCHARD RX LIMITED SAYS J.P. MORGAN, GOLDMAN SACHS & CO. LLC, COWEN ARE AMONG UNDERWRITERS TO IPO.ORCHARD RX LIMITED SAYS WEDBUSH PACGROW IS AMONG UNDERWRITERS TO IPO.ORCHARD RX LIMITED SAYS PROPOSED IPO PRICE IS AN ESTIMATE SOLELY FOR CALCULATING SEC REGISTRATION FEE.ORCHARD RX LIMITED SAYS GSK BENEFICIAL OWNERSHIP OF 17.9 PERCENT BEFORE THE U.S. IPO.  Full Article

Hitachi Chemical Advanced Therapeutics Solutions Says Signed A Three-Year Clinical Manufacturing Agreement With GSK
Monday, 1 Oct 2018 

Oct 1 (Reuters) - GlaxoSmithKline PLC ::HITACHI CHEMICAL ADVANCED THERAPEUTICS SOLUTIONS SAYS SIGNED A THREE-YEAR CLINICAL MANUFACTURING AGREEMENT WITH GSK.HITACHI CHEMICAL ADVANCED THERAPEUTICS SAYS CO TO MANUFACTURE GSK'S SPEAR T-CELL RECEPTOR THERAPY TARGETING NY-ESO-1 FOR U.S., CANADIAN, EUROPEAN TRIALS.HITACHI CHEMICAL ADVANCED THERAPEUTICS SOLUTIONS SAYS SIGNED A THREE-YEAR CLINICAL MANUFACTURING AGREEMENT WITH GSK.  Full Article

Glaxosmithkline PLC Reports 11.7 Pct Stake In Principia Biopharma Inc
Wednesday, 26 Sep 2018 

Sept 26 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC REPORTS 11.7 PERCENT STAKE IN PRINCIPIA BIOPHARMA INC AS OF SEPT. 18 - SEC FILING.  Full Article

GSK Says CHMP Recommends Expansion Of Trelegy COPD Label
Friday, 21 Sep 2018 

Sept 21 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC - CHMP RECOMMENDS EXPANSION OF TRELEGY COPD LABEL.GLAXOSMITHKLINE PLC - EMA COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) HAS ISSUED A POSITIVE OPINION TODAY SUPPORTING USE OF TRELEGY ELLIPTA.  Full Article

GSK Announces New Analysis On Asthma Drug Efficacy
Monday, 10 Sep 2018 

Sept 10 (Reuters) - GlaxoSmithKline PLC ::NEW ANALYSIS ON EFFICACY OF ANTI-IL5 BIOLOGICS SEA.NUCALA DEMONSTRATED GREATER REDUCTION IN EXACERBATIONS AND IMPROVED ASTHMA CONTROL.MEPOLIZUMAB DEMONSTRATED SIGNIFICANTLY GREATER IMPROVEMENTS IN ASTHMA CONTROL AS ASSESSED BY ACQ SCORE VERSUS RESLIZUMAB, BENRALIZUMAB.  Full Article

GSK Receives Complete Response Letter From U.S. FDA For Use Of Mepolizumab
Friday, 7 Sep 2018 

Sept 7 (Reuters) - :GSK - RECEIVES COMPLETE RESPONSE LETTER FROM US FDA FOR USE OF MEPOLIZUMAB IN COPD PATIENTS.SAYS CRL STATES THAT MORE CLINICAL DATA ARE REQUIRED TO SUPPORT AN APPROVAL.  Full Article

Glaxosmithkline Plans To Eliminate About 650 Positions In The U.S. - Spokeswoman
Wednesday, 5 Sep 2018 

Sept 5 (Reuters) - :GLAXOSMITHKLINE PLANS TO ELIMINATE ABOUT 650 POSITIONS IN THE U.S. - SPOKESWOMAN.  Full Article

GlaxoSmithKline Says EU Approves Nucala In Severe Asthma In Children
Thursday, 30 Aug 2018 

Aug 30 (Reuters) - GlaxoSmithKline PLC ::EU APPROVE NUCALA IN SEVERE ASTHMA IN CHILDREN.EC GRANTED MARKETING AUTHORISATION FOR NUCALA AS ADD-ON TREATMENT FOR SEVERE REFRACTORY EOSINOPHILIC ASTHMA IN PAEDIATRIC PATIENTS.  Full Article

UPDATE 1-Roche scores win in slowing aggressive type of breast cancer

* Trailing rivals, Roche seeking immunotherapy niches (Adds comments from lead study author, details on PD-L1 subgroup)