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GlaxoSmithKline PLC (GSK.L)

GSK.L on London Stock Exchange

1,725.60GBp
9 Dec 2019
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Latest Key Developments (Source: Significant Developments)

GSK seeks FDA approval for investigational HIV treatment
Thursday, 5 Dec 2019 

Dec 5 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE PLC - VIIV SUBMITS NDA TO FDA FOR FOSTEMSAVIR.GSK- SUBMITS NEW DRUG APPLICATION TO FDA FOR FOSTEMSAVIR, AN INVESTIGATIONAL, FIRST-IN-CLASS ATTACHMENT INHIBITOR FOR TREATMENT OF HIV IN ADULTS.GSK- SUBMISSION IS SUPPORTED BY DATA FROM PIVOTAL PHASE III BRIGHTE STUDY IN HEAVILY TREATMENT-EXPERIENCED PEOPLE LIVING WITH MULTIDRUG-RESISTANT HIV.GSK- VIIV HEALTHCARE PLANS TO SUBMIT REGULATORY APPLICATIONS FOR FOSTEMSAVIR TO EUROPEAN MEDICINES AGENCY AND OTHER GLOBAL AGENCIES IN COMING MONTHS.  Full Article

Hikma Pharmaceutical Says Completed FDA Response For Generic Advair
Wednesday, 27 Nov 2019 

Nov 27 (Reuters) - Hikma Pharmaceuticals PLC ::HIKMA COMPLETES FDA RESPONSE FOR GENERIC ADVAIR®.SUBMITTED TO US FDA RESPONSE TO DEFICIENCIES IN ANDA FOR A GENERIC VERSION OF GLAXOSMITHKLINE'S ADVAIR DISKUS.  Full Article

Exagen Inc Extends Collaboration Agreement With Glaxosmithkline For A Third Year
Friday, 22 Nov 2019 

Nov 22 (Reuters) - Exagen Inc ::EXAGEN INC - EXTENDED ITS COLLABORATION AGREEMENT WITH GLAXOSMITHKLINE PLC FOR A THIRD YEAR.EXAGEN INC - DETAILS OF AGREEMENT WITH GLAXOSMITHKLINE ARE CONFIDENTIAL.  Full Article

ViiV Healthcare Says To Develop Investigational Antibody N6lS For Treatment Of HIV-1
Thursday, 21 Nov 2019 

Nov 21 (Reuters) - ViiV Healthcare: :VIIV HEALTHCARE - TO DEVELOP INVESTIGATIONAL BROADLY NEUTRALISING ANTIBODY N6LS FOR TREATMENT AND PREVENTION OF HIV-1.VIIV HEALTHCARE - DEVELOPMENT OF INVESTIGATIONAL BNAB PART OF LICENSING DEAL BETWEEN GSK, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES.VIIV HEALTHCARE - TO INITIATE A PHASE IIA STUDY WITH MATERIAL MANUFACTURED BY NIAID VACCINE RESEARCH CENTER.  Full Article

GSK Says Phase 3 Study Of Nucala (Mepolizumab) Meets Primary Endpoint
Wednesday, 13 Nov 2019 

Nov 13 (Reuters) - GlaxoSmithKline PLC ::NUCALA (MEPOLIZUMAB) IS THE FIRST TREATMENT TO SHOW A SIGNIFICANT REDUCTION IN FLARES FOR PATIENTS WITH HYPEREOSINOPHILIC SYNDROME (HES).PHASE 3 STUDY MET ITS PRIMARY ENDPOINT FROM PIVOTAL STUDY OF NUCALA (MEPOLIZUMAB).SECONDARY ENDPOINTS FROM STUDY OF NUCALA (MEPOLIZUMAB) WERE ALSO STATISTICALLY SIGNIFICANT AND SUPPORTED PRIMARY ENDPOINT.BASED ON DATA FROM STUDY OF NUCALA (MEPOLIZUMAB) GSK PLANS TO PROGRESS REGULATORY SUBMISSIONS IN 2020.  Full Article

GlaxoSmithKline Upgrades 2019 Adjusted EPS Guidance
Wednesday, 30 Oct 2019 

Oct 30 (Reuters) - GlaxoSmithKline Plc ::Q3 ADJUSTED EPS ROSE 9 PERCENT TO 38.6 PENCE.Q3 SALES ROSE 16 PERCENT TO 9.4 BILLION STG.2019 ADJUSTED EPS GUIDANCE IMPROVED TO EXPECTATION OF AROUND FLAT AT CER FROM A DECLINE OF -3% TO -5%.QTRLY SALES FROM PHARMACEUTICALS £4.5 BILLION +7% AER, +3% CER.QTRLY SALES FROM VACCINES £2.3 BILLION +20% AER, +15% CER.QTRLY SHINGRIX SALES £535 MILLION +87% AER, +76% CER DRIVEN BY CONTINUING STRONG EXECUTION IN US.QTRLY SALES FROM CONSUMER HEALTHCARE £2.5 BILLION +30% AER, +25% CER (PRO-FORMA GROWTH +3% CER).QTRLY EARNINGS PER SHARE 31.4P.Q3 EARNINGS PER SHARE VIEW 33.34 PENCE, REVENUE VIEW 9.05 BILLION STG -- REFINITIV IBES DATA.GLAXOSMITHKLINE CEO EMMA WALMSLEY SAYS "GSK HAS MADE FURTHER GOOD PROGRESS IN Q3, WITH SALES GROWTH ACROSS ALL THREE BUSINESSES".FY2019 EARNINGS PER SHARE VIEW 117.40 PENCE -- REFINITIV IBES DATA.19P DIVIDEND DECLARED FOR QUARTER, CONTINUE TO EXPECT 80P FOR FY19.IN ONCOLOGY, ON TRACK TO FILE THREE INNOVATIVE MEDICINES BY YEAR END.NEW 2019 EPS VIEW REFLECTS OPERATING PERFORMANCE IN 9 MONTHS, INCREASED INVESTMENT IN RESEARCH AND DEVELOPMENT & PRIORITY ASSETS, LOWER EXPECTED EFFECTIVE TAX RATE.  Full Article

GSK Says Intravenous Benlysta Is First Biologic Treatment To Be Approved For Children With Lupus In Europe
Tuesday, 29 Oct 2019 

Oct 29 (Reuters) - GlaxoSmithKline PLC ::GLAXOSMITHKLINE - INTRAVENOUS BENLYSTA IS FIRST BIOLOGIC TREATMENT TO BE APPROVED FOR CHILDREN WITH LUPUS IN EUROPE.GSK - EC DECIDED TO EXTEND TO CHILDREN 5 YRS & OLDER, EXISTING ADULT INDICATION FOR BELIMUMAB AS ADD-ON THERAPY IN PATIENTS WITH LUPUS.  Full Article

Pfizer Reports Q3 Earnings Per Share $1.36
Tuesday, 29 Oct 2019 

Oct 29 (Reuters) - Pfizer Inc ::PFIZER REPORTS THIRD-QUARTER 2019 RESULTS.Q3 EARNINGS PER SHARE $1.36.Q3 EARNINGS PER SHARE ESTIMATE $0.62 -- REFINITIV IBES DATA.Q3 ADJUSTED EARNINGS PER SHARE $0.75.UPDATED CERTAIN 2019 FINANCIAL GUIDANCE RANGES.SEES FY 2019 REVENUE $51.2 TO $52.2 BILLION.QTRLY 2019 REVENUES OF $12.7 BILLION, REFLECTING 3% OPERATIONAL DECLINE.SEES FY 2019 ADJUSTED EARNINGS PER SHARE $2.94 TO $3.00.RAISED MIDPOINT OF 2019 GUIDANCE RANGE FOR REVENUES BY $0.2 BILLION DRIVEN BY A $0.4 BILLION OPERATIONAL IMPROVEMENT.FY2019 EARNINGS PER SHARE VIEW $2.82, REVENUE VIEW $51.32 BILLION -- REFINITIV IBES DATA.QTRLY BIOPHARMA REVENUE $10,108 MILLION VERSUS $9,422 MILLION.IN QUARTER, UPJOHN REVENUES WERE NEGATIVELY IMPACTED PRIMARILY BY JULY 2019 LOSS OF EXCLUSIVITY OF LYRICA IN U.S..QTRLY REVENUE, EXCLUDING IMPACT FROM CONSUMER HEALTHCARE, WERE FLAT OPERATIONALLY.IN QUARTER, CONSUMER HEALTHCARE REVENUES DECLINED AS A RESULT OF COMPLETION OF JV TRANSACTION WITH GSK DURING QUARTER.PFIZER - UPDATED 2019 FINANCIAL GUIDANCE PRIMARILY TO REFLECT FINANCIAL RESULTS THROUGH FIRST NINE MONTHS, CONFIDENCE IN BUSINESS GOING FORWARD.NOW EXPECTS UPJOHN REVENUES IN CHINA TO GROW BY MID-TO-HIGH-SINGLE DIGITS OPERATIONALLY FOR FULL-YEAR 2019 COMPARED WITH 2018.QTRLY UPJOHN REVENUE $2.2 BILLION, DOWN 26% OPERATIONALLY, PRIMARILY DRIVEN BY SIGNIFICANT VOLUME DECLINES FOR LYRICA IN U.S..Q3 REVENUE VIEW $12.26 BILLION -- REFINITIV IBES DATA.  Full Article

GSK starts late-stage trial for experimental antibiotic
Monday, 28 Oct 2019 

Oct 28 (Reuters) - GlaxoSmithKline PLC ::GSK STARTS A PHASE III CLINICAL PROGRAMME FOR A POTENTIAL FIRST-IN-CLASS ANTIBIOTIC, GEPOTIDACIN.GSK SAYS TRIAL INVESTIGATING USE OF GEPOTIDACIN FOR UNCOMPLICATED URINARY TRACT INFECTION AND UROGENITAL GONORRHOEA.GSK - PHASE III PROGRAMME HAS TWO STUDIES, ONE COMPARING GEPOTIDACIN TO CEFTRIAXONE PLUS AZITHROMYCIN, SECOND TO COMPARE GEPOTIDACIN TO NITROFURANTOIN.GSK SAYS FIRST RESULTS FROM PROGRAMME ARE EXPECTED BY THE END OF 2021.  Full Article

GSK Divests Two Travel Vaccines For Potential Consideration Of Up To EUR 955 Mln
Monday, 21 Oct 2019 

Oct 21 (Reuters) - GlaxoSmithKline PLC ::GSK DIVESTS TWO TRAVEL VACCINES TO BAVARIAN NORDIC.TO RECEIVE UPFRONT PAYMENT OF APPROXIMATELY EUR301 MILLION (£259M) AND MILESTONE PAYMENTS FOR A TOTAL CONSIDERATION OF UP TO EUR955 MILLION (£822M).VALUE OF INVENTORY AT ANTICIPATED CLOSING DATE IS ESTIMATED TO BE EUR 159 MILLION.NO EMPLOYEES OR MANUFACTURING FACILITIES ARE BEING TRANSFERRED AS PART OF THIS TRANSACTION.NO EMPLOYEES OR MANUFACTURING FACILITIES ARE BEING TRANSFERRED AS PART OF TRANSACTION.DIVESTMENT OF TRAVEL VACCINES RABIPUR FOR PREVENTION OF RABIES, AND ENCEPUR FOR PREVENTION OF TICK-BORNE ENCEPHALITIS, TO BAVARIAN NORDIC.VACCINES BEING DIVESTED TO BE MANUFACTURED PRIMARILY AT MARBURG SITE IN GERMANY UNTIL FULL PRODUCTION TRANSFERRED TO BAVARIAN NORDIC.DEAL EXPECTED TO CLOSE BY END OF 2019, CONDITIONAL ON ANTI-TRUST APPROVAL AND APPROVAL OF BAVARIAN NORDIC'S RIGHTS ISSUE BY ITS SHAREHOLDERS.  Full Article

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GSK seeks FDA approval for investigational HIV treatment

GlaxoSmithKline Plc said on Thursday its HIV unit has submitted a new drug application to the U.S. Food and Drug Administration seeking approval for fostemsavir, an experimental treatment for HIV in adults.