GSK GlaxoSmithKline PLC

46.06
+0.14  (+0%)
Previous Close 45.93
Open 46.17
Price To Book 24.25
Market Cap 114,916,547,541
Shares 2,494,660,752
Volume 794,336
Short Ratio 2.24
Av. Daily Volume 2,741,200
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  1. GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer

    Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency (HRD) Zejula is now the only, once-daily PARP inhibitor approved as monotherapy

  2. GSK Submits Filing to FDA for Trelegy Ellipta Use in Patients With Asthma

    GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of

  3. Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

    The PRIMA study, presented in a Presidential Symposium at the 2019 European Society for Medical Oncology congress and simultaneously published in The New England Journal of Medicine, demonstrates that niraparib treatment

  4. Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

    The PRIMA study, presented in a Presidential Symposium at the 2019 European Society for Medical Oncology congress and simultaneously published in The New England Journal of Medicine, demonstrates that niraparib treatment

  5. GSK presents new data showing promising anti-tumour activity with GSK3359609, an ICOS receptor agonist, in combination with pembrolizumab in head and neck squamous cell carcinoma (HNSCC)

    LONDON, Sept. 28, 2019 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced GSK3359609, an inducible T cell co-stimulatory (ICOS) agonist antibody designed to selectively enhance T cell function, showed

Drug Information

Drug catalyst information is displayed when you hover over / tap on the stage bar graph.

Phase 3 trial to be initiated 1H 2018.
TSR-042
First-line ovarian cancer
FDA Approval announced July 23, 2018.
Tafenoquine
Malaria
Approval announced April 24, 2018 for expanded label.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Phase 3 data released September 20, 2017 - primary endpoint met.
Closed Triple - IMPACT
COPD
Approval announced December 12, 2017.
Mepolizumab
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Phase 3 trial met primary endpoint - November 12, 2019.
Mepolizumab
Severe hypereosinophilic syndrome (HES)
Phase 1/2 trial ongoing. Data at ASCO 2018 noted ORR 25%.
Niraparib and Keytruda (TOPACIO)
Triple-negative Breast Cancer or Ovarian Cancer
Approval announced January 11, 2018.
Fluarix Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
Phase 3 data released July 15, 2019 met primary endpoint. Presentation at ESMO 2019 noted PFS, HR 0.62.
Niraparib - PRIMA
First-line ovarian cancer
Approval announced September 18, 2017.
Trelegy Ellipta (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approval announced November 21, 2017.
Dolutegravir + rilpivirine
HIV
Advisory Committee July 25, 2018 voted 3-16 against recommending approval. CRL issued September 7, 2018.
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
FDA approval announced April 8, 2019.
Dolutegravir + lamivudine
HIV
Phase 3 interim analysis due 1H 2020.
Daprodustat - ASCEND-D
Anemia
Phase 3 data due 2H 2020.
Cabotegravir
HIV
Development discontinued due to lack of efficacy.
Danirixin
Chronic obstructive pulmonary disease (COPD)
Approval announced October 20, 2017.
Shingrix
Shingles
Approval announced July 21, 2017.
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
sNDA filing announced October 2, 2019.
Closed Triple - CAPTAIN
Asthma
Approval announced September 19, 2017.
Closed Triple
COPD
CRL January 11 2017. FDA Approval announced October 25, 2017 following resubmission.
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Phase 3 trial no longer be expected to serve as a registration trial - noted March 27, 2017.
Niraparib - BRAVO
Cancer - breast
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
FDA Approval announced October 23, 2019.
Niraparib - (QUADRA trial)
Ovarian cancer
Approved September 2, 2015.
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Phase 1 pivotal data and BLA filing due 2H 2019.
TSR-042 - GARNET
Endometrial cancer
NDA filing announced April 29, 2019. Estimated PDUFA date April 28, 2020.
Dolutegravir + rilpivirine
Injectable 2DR in HIV
Phase 3 data due 2H 2020.
Benlysta (belimumab) and rituximab
Systemic lupus erythematosus (SLE)
Phase 3 ContRAst trial initiation announced July 3, 2019.
Otilimab (MOR103/GSK3196165)
Rheumatoid Arthritis
Phase 1 data due 2H 2020.
TSR-022 + TSR-042 AMBER
Solid tumors
Phase 2 data due 2H 2019.
Niraparib + bevacizumab OVARIO
Ovarian cancer
Phase 1 trial ongoing.
TSR-033 - CITRINO
Solid tumors
Phase 3 data due 1H 2020.
Mepolizumab - SYNAPSE
Nasal polyps
Phase 2 pivotal data met primary endpoint - August 23, 2019.
GSK’916 - belantamab mafodotin (BCMA)
Multiple myeloma
FDA Approval announced June 6, 2019.
Mepolizumab
Severe eosinophilic asthma - pediatric
Phase 2 initial data to be presented at ASCO GU February 14, 2019. ORR 40%.
Niraparib (Galahad)
Castration-Resistant Prostate Cancer
Phase 3 trial met primary endpoint - June 14, 2018. 96-week data presented July 24, 2019.
Dolutegravir + lamivudine (GEMINI 2)
Phase 3 trial met primary endpoint - June 14, 2018. 96-week data due 3Q 2019.
Phase 3 primary endpoint met - August 22, 2019.
Cabotegravir + rilpivirine - ATLAS2M
HIV
sNDA filing announced October 16, 2019.
Dolutegravir + lamivudine TANGO
HIV
FDA approval announced September 12, 2019.
Mepolizumab
Severe eosinophilic asthma (6-11 yrs)
Phase 3 trial initiation announced October 28, 2019. Data due by the end of 2021.
Gepotidacin
Uncomplicated urinary tract infection (uUTI)
Phase 2b data significantly reduced incidence of pulmonary tuberculosis disease - October 29, 2019.
M72/AS01E
Pulmonary tuberculosis
Phase 2 pivotal data due 2H 2020.
Zejula and dostarlimab - MOONSTONE
Ovarian cancer
NDA filing announced December 5, 2019.
Fostemsavir
HIV

Latest News

  1. GSK Announces U.S. Food and Drug Administration Approval of Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer

    Expanded indication allows for treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency (HRD) Zejula is now the only, once-daily PARP inhibitor approved as monotherapy

  2. GSK Submits Filing to FDA for Trelegy Ellipta Use in Patients With Asthma

    GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of

  3. Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

    The PRIMA study, presented in a Presidential Symposium at the 2019 European Society for Medical Oncology congress and simultaneously published in The New England Journal of Medicine, demonstrates that niraparib treatment

  4. Phase 3 PRIMA trial of Zejula® (niraparib) is the first study to show a PARP inhibitor significantly improves PFS, regardless of biomarker status, when given as monotherapy in women with first-line platinum responsive advanced ovarian cancer

    The PRIMA study, presented in a Presidential Symposium at the 2019 European Society for Medical Oncology congress and simultaneously published in The New England Journal of Medicine, demonstrates that niraparib treatment

  5. GSK presents new data showing promising anti-tumour activity with GSK3359609, an ICOS receptor agonist, in combination with pembrolizumab in head and neck squamous cell carcinoma (HNSCC)

    LONDON, Sept. 28, 2019 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced GSK3359609, an inducible T cell co-stimulatory (ICOS) agonist antibody designed to selectively enhance T cell function, showed

  6. Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma

    GlaxoSmithKline (NYSE:GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for use in children as young as six years old who are living with severe eosinophilic asthma.