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GLPG3667 is an investigational, novel, oral, reversible, and selective tyrosine kinase 2 (TYK2) inhibitor GLPG3667 is currently in development for the treatment of inflammatory and auto-immune diseases and, if approved, has the potential to be the first selective oral TYK2 inhibitor in dermatomyositis Mechelen, Belgium; 23 May 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was dosed in GALARISSO, the Phase 2 dermatomyositis (DM) trial with GLPG3667
9 poster presentations and 3 abstracts publications reinforce Galapagos' commitment to immunology and the rheumatoid arthritis (RA) patient and healthcare professional communityNew analyses will be presented from long-term extension studies providing insights into filgotinib's effectiveness and safetyInterim baseline characteristics, effectiveness and safety outcomes will be published online from the real-world FILOSOPHY study in RA patients Mechelen, Belgium; 22 May 2023, 22:01 CET; Galapagos N
Mechelen, Belgium; 5 May 2023, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,975,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 5 May 2023, the Board of Directors of Galapagos approved “Subscription Right Plan 2023 BE”, intended for members of personnel of the company and its Belgian subsidiary, “Subscription Rig
Progress with immunology and oncology pipeline: First patients dosed in pivotal Phase 3 OLINGUITO study with filgotinib in axial spondyloarthritis (AxSpA)Clinical sites opened to start patient recruitment in Phase 2 GALARISSO study with TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis (DM)On track to report topline results from two CAR-T Phase 1/2 studies in hemato-oncology mid-2023Further expanding CAR-T point-of-care network in Europe, with IND filing in the US expected before ye
Mechelen, Belgium; 2 May 2023, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced the departure of Bart Filius, President, Chief Operating Officer and Chief Financial Officer. Bart Filius joined Galapagos in 2014 as Chief Financial Officer and subsequently took on the responsibility as Chief Operating Officer in 2017. In 2021, he was named President of the company. In his roles, Bart oversaw finance, business development, commercial strategy, human resource
OLINGUITO Phase 3 program in adults with axial spondyloarthritis (AxSpA) to include two parallel studies to investigate the efficacy and safety of filgotinib in patients with active radiographic AxSpA (r-AxSpA) and non-radiographic AxSpA (nr-AxSpA)Results from Phase 2 TORTUGA study showed that filgotinib 200mg was efficacious and well-tolerated in patients with r-AxSpAFilgotinib, an oral, once-daily JAK1 preferential inhibitor, is currently approved in Europe and Japan for the treatment of rheum
Mechelen, Belgium; 25 April 2023, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announces the approval of all resolutions proposed at its annual shareholders’ meeting (AGM) held today at 14.00 CET. The AGM approved, amongst other items, the re-appointments of Mr. Peter Guenter as non-executive independent director for a period of 4 years, and of Mr. Daniel O’Day and Dr. Linda Higgins as non-executive non-independent directors for a period of 4 years, all effective as of todaythe appoin
Galapagos to transfer drug discovery and research activities in Romainville, France to NovAliX, a drug-discovery focused Contract Research Organization (CRO) based in Strasbourg, FranceNovAliX to assume Galapagos’ research capabilities, and Galapagos retains flexibility to access necessary expertise and resources through a five year-collaboration agreementTransaction in the context of Galapagos’ strategic reset announced in 2022; closing expected in July 2023 Mechelen, Belgium and Strasbourg, Fr
Publication of annual report for financial year 2022Annual Shareholders’ Meeting proposed resolutions include re-appointment of Board members and appointment of new statutory auditor Mechelen, Belgium; 23 March 2023, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today publishes its annual report for the financial year 2022 and announces its Annual Shareholders’ Meeting, to be held on Tuesday 25 April 2023, at 2:00 p.m. (CET), at the registered office of the company. T
Mechelen, Belgium; 20 March 2023, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises. Galapagos issued 61,560 new ordinary shares on 20 March 2023, for a total capital increase (including issuance premium) of EUR 1,769,850.00. In accordance with Belgian transparency legislation1, Galapagos also wishes to note that its total share capital currently amounts to EUR 356,444,938.61, the total number of
Six presentations demonstrate Galapagos’ commitment to the inflammatory bowel disease (IBD) communityNew analyses from Phase 3 SELECTION and SELECTION long-term extension (LTE) studies of Jyseleca® (filgotinib, an oral, once daily, JAK1 preferential inhibitor) will be presentedSELECTIONLTE showed that filgotinib maintained a consistent safety profile; symptomatic remission rates and health-related quality of life (HRQoL) improved in patients with moderate to severe active ulcerative colitis (UC)
Key 2022 and post-period events Dr. Paul Stoffelsi appointed as Chief Executive Officer and Chairman of the Board of DirectorsImplemented new strategic direction to accelerate innovation and time-to-patients: Set-up of new innovation model and fit-for-purpose R&D organizationFocus on key therapeutic areas of immunology and oncologyDiscontinuation of activities in fibrosis and kidney diseaseExpansion of drug modalities beyond small molecules, including biologicals and CAR-T Entered into the field
All 7 out of 7 eligible patients with relapsed/refractory Chronic Lymphocytic Leukemia, with or without Richter’s transformation, responded to treatment (Objective Response Rate of 100%)GLPG5201 showed an acceptable safety profile with no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS) observed Mechelen, Belgium; 9 February 2023, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today presented encouraging data at the Europea
The two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10In the maintenance phase, filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission and endoscopic response at Week 58The safety findings were generally consistent with the known profile of filgotinib in rheumatoid arthritis (RA) and ulcerative colitis (UC)Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline
Mechelen, Belgium; 10 January 2023, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from FMR LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 9 January 2023 from FMR LLC, who notified that it holds 3,903,804 of Galapagos’ voting rights, consisting of 3,801,504 ordinary shares and 102,300 equivalent financial instruments. FMR LLC controls investment funds Fidelity Management & Resea
Mechelen, Belgium; 3 January 2023, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) will participate in the 41th Annual J.P. Morgan Healthcare Conference on January 9-12, 2023. Paul Stoffels1, CEO, will present on Monday, January 9 at 4.30 p.m. PST/7.30 p.m. ET (Tuesday, January 10 at 01.30 a.m. CET). The presentation will be a live audio webcast and can be accessed via the following link. A replay of the webcast will be available on the Galapagos’ website at https://www.glpg.com/webcasts. Abou
Mechelen, Belgium; 22 December 2022, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced changes in the Executive Committee effective 1 January 2023. Dr. Walid Abi-Saab has decided to retire from the company as Chief Medical Officer and member of the Executive Committee, effective 31 December 2022. He will stay with Galapagos until 31 May 2023 to ensure a smooth transition. The company also announces the retirement of André Hoekema who joined Galapagos in 2005 as Chief Business Off
6 out of 7 eligible patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL) responded to treatment (ORR of 86%) and all responding patients achieved complete response (CR)No grade 3 or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in any of the eligible patientsInitial data suggest the potential of our decentralized manufacturing and supply model for faster, convenient, and efficient delivery of GLPG5101 at the point-
Supportive outcome for Jyseleca as treatment option with a positive benefit/risk profile after review of safety data of all JAK inhibitors approved in Europe for treatment of inflammatory conditions This follows the recommended harmonization of EU labels for all JAK inhibitors by Pharmacovigilance Risk Assessment Committee (PRAC)For patients aged ≥65 years, current or long-time past smokers and patients with a history of atherosclerotic cardiovascular (CV) disease or other CV and malignancy risk
Preliminary results from real-world FILOSOPHY, FILgotinib Observational Study Of Patient Health-related outcomes, in the first 200 patients with moderately to severely active rheumatoid arthritis (RA)Data showed that filgotinib induced rapid relief in pain and fatigue as early as Week 1 as well as improvements in disease activity1 at Month 17 additional presentations encompassing key analyses of filgotinib, including long term, integrated safety data and safety data in specific subpopulations, d
Guiding principles for a sustainable future: Invest in strategic therapeutic areas of oncology and immunologyRebuild and accelerate portfolio of transformational medicines in high unmet medical needsCombine internal with external innovation Capital allocation: Discontinue fibrosis and kidney disease to further invest in oncologyLeverage strong balance sheet through disciplined cash management and smart business development Oncology roadmap: Validate point-of-care CAR-T delivery model with proven
Clear path forward for accelerated growth and value creation Reshape innovation model and build fit-for-purpose organization in key strategic therapeutic areas: immunology and oncologyJyseleca® 2022 net sales guidance further increased to €80-€90 million from €75-€85 million at H1 2022First nine months 2022 financial results: Strong performance of Jyseleca franchise with €60.5 million in net salesGroup revenues of €410.2 millionOperating loss of €135.1 millionCash and current financial investmen
Mechelen, Belgium; 17 October 2022, 07.30 CET; - Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will host its R&D Day 2022 for analysts, investors and financial press on Friday, 4 November 2022. The live event will take place at the Yale Club in New York City from 8:00 am to 10:30 am EDT (13.00 to 15.30 CET). The event will feature presentations by key opinion leaders (KOLs) and management on the company’s strategic objectives, scientific pipeline and commercial progress. The com
Five presentations demonstrate Galapagos' commitment to inflammation and the ulcerative colitis (UC) communityNew analyses will be presented from the SELECTION data set on prediction of response and remission, histology data and trajectory modelPresentation on safety data of filgotinib in enriched risk population in rheumatoid arthritis Mechelen, Belgium; 6 October 2022, 22.01 CET, Galapagos NV (Euronext & NASDAQ: GLPG) will present data at the United European Gastroenterology (UEG) Week 2022, t
Type II variation1 regulatory application to amend the European label of Jyseleca® (filgotinib) based on data from MANTA and MANTA-RAy studies in patients with inflammatory bowel disease (IBD) and rheumatic conditions (RC) respectively Mechelen, Belgium; 3 October 2022, 22.01 CET, regulated information; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted