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Galapagos NV (GLPG)

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  • Globe Newswire

    Galapagos increases share capital through subscription right exercises

    Mechelen, Belgium; 7 June 2021, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises. Galapagos issued 10,940 new ordinary shares on 7 June 2021, for a total capital increase (including issuance premium) of €325,279. Pursuant to the subscription right exercise program of Galapagos’ management board, members of the management board automatically are committed to exercise a minimum number of subscript

  • Globe Newswire

    Galapagos to present data on rheumatoid arthritis at the upcoming European League Against Rheumatism (EULAR) congress

    Mechelen, Belgium, 27 May 2021, 22:01 CET, – Galapagos NV (Euronext & Nasdaq: GLPG) today announced that 15 abstracts, including scientific updates, and data providing further understanding on the profile of filgotinib as a treatment for people with Rheumatoid Arthritis (RA), will be presented at the European League Against Rheumatism (EULAR) virtual congress 2021, 2-5 June. New data analyses on the safety profile of filgotinib, an oral, once-daily, JAK1 preferential inhibitor for the treatment of moderately to severely active RA, are presented from seven trials from the development program for filgotinib (DARWIN 1 and 2 and FINCH 1, 2 and 3 and two long term extension studies DARWIN 3 and FINCH 4). Data will be shared on the incidence of infections and serious infections (OP0126) and herpes zoster virus (POS0092), as well as the effects of concomitant use of statins in filgotinib-treated patients with rheumatoid arthritis (POS0660) and the effect of filgotinib on the pharmacokinetics of rosuvastatin, atorvastatin, and pravastatin (AB0259). Galapagos is also presenting scientific research investigating the hypothesis that differences in the selectivity of molecules in the JAK inhibitor class could result in a differential functional modulation of natural killer (NK) cells, which could be a component of the differences in clinical safety profiles of JAK inhibitors (POS0224). In addition to the clinical data, Galapagos will present initial results from a European real-world survey investigating patient and physician attitudes to setting treatment target goals in RA, as a strategy for managing the disease (POS0305). “At Galapagos, we are working to understand the different dimensions of treatment needs that people living with RA say are important, reflecting a deeper understanding of their complex lives and needs,” said Walid Abi-Saab, MD, Chief Medical Officer at Galapagos. “In our drive to deliver innovation and make a real difference where the patient need is greatest, we are excited to be sharing a range of data and insights that represent our ongoing work to understand what matters most to people living with RA and to deliver on the health outcomes most important to patients.” The presentations at EULAR capture a broad range of research and commitment to the RA community, demonstrating the importance of patient and clinical insight and highlighting Galapagos’ position as a science-driven company led by research into patient unmet needs. Galapagos Key Abstracts Title Authors Oral | Poster Number Time and Date Herpes Zoster in the Filgotinib Rheumatoid Arthritis Program Kevin Winthrop, et al POS0092 Poster tour: 03 June 2021, 11:50:00-13:30:00 CEST Infections and Serious Infections in the Filgotinib Rheumatoid Arthritis Program James Galloway, et al OP0126 Session: 03 June 2021, 10:15:00-11:45:00 CEST Concomitant Use of Statins in Filgotinib-Treated Patients with Rheumatoid Arthritis Peter C Taylor, et al POS0660 Display: Wednesday, 02 June 2021, 08:00 CEST – Saturday 05 June 2021, 23:59 CEST Evaluation of the effect of filgotinib on the pharmacokinetics of rosuvastatin, atorvastatin, and pravastatin Kacey Anderson, et al AB0259 Publish: Abstract Book official supplement to the Annals of Rheumatic Diseases ARD Selectivity of clinical JAK inhibitors and the impact on Natural Killer (NK) cell functional responses Paqui G. Traves, et al POS0224 Poster tour: 04 June 2021, 11:50:00-13:30:00 CEST Physician and Patient Attitudes towards Treat-to-Target, its Implementation and Stated Treatment Goals in Patients with Rheumatoid Arthritis in a Real-World Setting across Europe Bruno Fautrel, et al POS0305 Poster tour: 05 June 2021, 10:30:00-12:00:00 CEST For further information on the EULAR congress visit: www.congress.eular.org For further details about the filgotinib rheumatoid arthritis clinical trial program, visit www.clinicatrials.gov: FINCH 1 NCT02889796; FINCH 2 NCT02873936; FINCH 3 NCT02886728; FINCH 4 NCT03025308; DARWIN 1 NCT01888874; DARWIN 2 NCT01894516; DARWIN 3 NCT02065700; FITZROY NCT02048618 About rheumatoid arthritisRA is a chronic inflammatory disease. In RA a person's immune system attacks healthy cells, causing painful swelling in affected parts of the body, primarily in the joints.1 RA can cause tissue damage resulting in chronic pain, unsteadiness and physical disability.1 More than 2.3 million individuals are living with RA in Europe2 and women are 2 – 3 times more likely to develop RA.3 The onset of disease is typically between 30 and 50 years of age.4 About filgotinib Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries. About the filgotinib collaborationGilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov. About Galapagos Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com. Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Available at: https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html. Accessed September 2020.National Rheumatoid Arthritis Society. The Burden of Rheumatoid Arthritis across Europe a Socioeconomic Survey (BRASS). Summary Report. Available at: https://www.nras.org.uk/data/files/Publications/Surveys%20Reports/UoC_HCD_BRASS%20Summary%20Report%20FINAL.pdf. Accessed September 2020Arthritis Foundation. Arthritis by the Numbers. Available at: https://www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf. Accessed September 2020.Wasserman, A. Diagnosis and Management of Rheumatoid Arthritis. American Family Physician. Available at: https://www.aafp.org/afp/2011/1201/p1245.html. Accessed September 2020 Contacts Investors:Elizabeth GoodwinVP Investor Relations +1 781 460 1784 Sofie Van GijselSenior Director Investor Relations+32 485 19 14 15ir@glpg.com Media:Carmen VroonenGlobal Head of Communications & Public Affairs+32 473 824 874 Anna GibbinsSenior Director Therapeutic Areas Communications+44 7717 801900communications@glpg.com Forward Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, the risk that the results of ongoing clinical studies with filgotinib will not support continued approval of filgotinib for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs) due to safety, efficacy or other reasons or would not support approval of filgotinib for any other indication, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, risks related to the implementation of the transition of European commercialization responsibility for filotinib from Gilead to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Attachment PDF version

  • Globe Newswire

    Galapagos announces first patient enrolled in FILOSOPHY study to advance understanding of Jyseleca (filgotinib) effectiveness and safety in a real-world setting

    Study uses mobile device technology to support capture of patient-reported outcomes during early and ongoing use of study treatment amongst patients with rheumatoid arthritis Mechelen, Belgium; 18 May 2021; 22.01 CET; – Galapagos NV (Euronext & Nasdaq: GLPG) today announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis (RA) in clinical practice. The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes (PROs) in patients with moderate to severe active RA while receiving filgotinib in a real-world setting for up to two years. Mobile device technology will play a central role in collection of PROs, allowing data collection to begin within the first weeks of treatment. This may also prove to be an effective tool during the pandemic, while in-person clinic visits are harder to achieve. FILOSOPHY will enable the gathering of comprehensive real-world data in a population that may not be fully represented in clinical trials, as randomized, placebo-controlled trials require strict patient inclusion criteria. These data will expand the evidence base to support the appropriate use of filgotinib in clinical practice. Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos said, “This study can enhance our understanding about the effectiveness and safety of filgotinib from the experiences of RA patients who are prescribed the treatment in a real-world healthcare setting. We aim to improve disease management and outcomes for people living with this debilitating condition.” Professor Gerd Burmester, Director Department of Rheumatology and Clinical Immunology, Charité, Universitätsmedizin, Berlin and FILOSOPHY Steering Committee Member, added, “We expect that use of remote devices to collect treatment outcomes data will give us more comprehensive insights into early treatment effects in relation to patient reported outcomes, including pain and fatigue. In addition, we are interested to understand how long patients stay on treatment and how this could be affected by patient characteristics or treatment effects.” About Rheumatoid ArthritisRA is a chronic inflammatory disease. In RA a person's immune system attacks healthy cells, causing painful swelling in affected parts of the body, primarily in the joints.1 RA can cause tissue damage resulting in chronic pain, unsteadiness and physical disability.1 More than 2.3 million individuals are living with RA in Europe2 and women are 2 – 3 times more likely to develop RA3. The onset of disease is typically between 30 and 50 years of age4. About the FILOSOPHY Phase 4 studyFILOSOPHY (FILgotinib Observational Study Of Patient Health related outcomes over 2 Years), is a prospective, non-interventional cohort study enrolling approximately 1500 patients across Europe. Data will be collected by the clinical sites and patients using an electronic case report form (eCRF) and mobile devices. Each enrolled patient will be followed for 24 months or until discontinuation of study, whichever occurs first. Baseline assessments may be collected within 30 days prior to the first dose of filgotinib. The primary objective of the study is to evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation. Secondary and exploratory objectives include effectiveness, evaluation of the effect of filgotinib on patient reported outcomes (PROs) including on pain, fatigue and work productivity, rate of adverse events (AEs) and serious adverse events (SAEs) as well as adverse events of interest, including serious and opportunistic infections (including herpes zoster), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), hyperlipidemia, malignancies, non-melanoma skin cancer (NMSC), and gastrointestinal (GI) perforation. For more information go to ClinicalTrials.gov Identifier: NCT04871919 About filgotinib Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the Europe Union, Great Britain and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other jurisdictions. About the filgotinib collaborationGilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe and Japan and a global Phase 3 program is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at www.clinicaltrials.gov. About Galapagos Galapagos NV discovers, develops and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com. Centers for Disease Control and Prevention. Rheumatoid Arthritis (RA). Available at: https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html. Accessed September 2020.National Rheumatoid Arthritis Society. The Burden of Rheumatoid Arthritis across Europe a Socioeconomic Survey (BRASS). Summary Report. Available at: https://www.nras.org.uk/data/files/Publications/Surveys%20Reports/UoC_HCD_BRASS%20Summary%20Report%20FINAL.pdf. Accessed September 2020Arthritis Foundation. Arthritis by the Numbers. Available at: https://www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf. Accessed September 2020.Wasserman, A. Diagnosis and Management of Rheumatoid Arthritis. American Family Physician. 2011;84(11):1245-1252. Contacts Investors:Elizabeth GoodwinVP Investor Relations +1 781 460 1784 Sofie Van GijselSenior Director Investor Relations+32 485 19 14 15ir@glpg.com Media:Carmen VroonenGlobal Head of Communications & Public Affairs+32 473 824 874 Anna GibbinsSenior Director Therapeutic Areas Communications+44 7717 801900communications@glpg.com Forward-looking statementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the FILOSOPHY study, competitive developments, and regulatory approval requirements, the risk that the results of the FILOSOPHY study will not support continued approval of Jyseleca for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs) due to safety, efficacy or other reasons, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, risks related to the implementation of the transition of European commercialization responsibility to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations. Attachment PDF version