Filgotinib

Galapagos announces full year 2023 results and outlook for 2024

Retrieved on: 
Thursday, February 22, 2024
Technology transfer, CD19, Filgotinib, Lupus, Multiple myeloma, DL2, Dermatomyositis, Acceleration, Baltic, BCMA, Mantle cell lymphoma, European Commission, Indolent lymphoma, JAK1, Safety, EBMT, RT, TYK2, CFO, PRAC, MAA, Richter's transformation, Euronext, Executive Committee, JAK, UC, Patient, SLE, Pharmaceutical industry

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

Galapagos concludes strategic evaluation and signs letter of intent to transfer Jyseleca® business to Alfasigma

Retrieved on: 
Monday, October 30, 2023
Linda, Euronext, International Financial Reporting Standards, Galapagos NV, International Air Transport Association code, Thirty-second Amendment of the Constitution Bill 2013, International, Committee, Filgotinib, Workforce, News, Acquisition, Related party transaction, UK, Statutory auditor, CET, Collaboration, CFO, European, Patient, Letter, Cryptocurrency, Pharmaceutical industry, Management, Commercial property, Audit, Pamlab, Galápagos Islands

Galapagos will pay up to €40 million by June 2025 to Alfasigma for Jyseleca® related development activities.

Key Points: 
  • Galapagos will pay up to €40 million by June 2025 to Alfasigma for Jyseleca® related development activities.
  • “Today’s news is the result of a thoughtful, in-depth analysis, and represents the successful conclusion of the strategic evaluation process for Jyseleca®.
  • The acquisition of Galapagos' Jyseleca® business represents another important milestone in Alfasigma's international transformation and growth path and fits perfectly with our Company's core business areas.
  • It is the intention in the contemplated transaction between Galapagos and Alfasigma that the amended Filgotinib Agreement will be assigned by Galapagos to Alfasigma.

Galapagos announces first half-year 2023 financial results

Retrieved on: 
Thursday, August 3, 2023
Exercise, Filgotinib, RA, CET, CD19, JAK, CTA, SLE, Burn, Gilead, UC, Patient, Multiple myeloma, TYK2, Hematology, Drug discovery, Growth, IND, Arthritis, BCMA, Cryptocurrency, Pharmaceutical industry

R&D expenditure in the first six months of 2023 amounted to €211.9 million, compared to €249.5 million for the first six months of 2022.

Key Points: 
  • R&D expenditure in the first six months of 2023 amounted to €211.9 million, compared to €249.5 million for the first six months of 2022.
  • Net financial income in the first six months of 2023 amounted to €30.6 million, compared to net financial income of €67.7 million for the first six months of 2022.
  • Current financial investments and cash and cash equivalents totaled €3,874.9 million on 30 June 2023, as compared to €4,094.1 million on 31 December 2022.
  • Galapagos’ financial report for the first six months ended 30 June 2023, including details of the unaudited consolidated results, is accessible on the financial reports section of our website .

Galapagos demonstrates commitment to immunology with new data in rheumatoid arthritis at EULAR 2023

Retrieved on: 
Monday, May 22, 2023
Galapagos NV, ACR, Abstract, CV, CET, FIL, Isabella Tree, JAK, Safety, Risk, Doctor of Philosophy, Rheumatoid arthritis, Pain, European Alliance of Associations for Rheumatology, Euronext, MD, Patient, RWE, Filgotinib, EULAR, Congress, Disease, Pharmaceutical industry, Frankincense, Galápagos Islands, Immunology

“We are focused on advancing treatment options for chronic, debilitating immune-mediated diseases such as RA and are excited to present further analyses on filgotinib’s efficacy and safety profile at this year’s EULAR congress,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos.

Key Points: 
  • “We are focused on advancing treatment options for chronic, debilitating immune-mediated diseases such as RA and are excited to present further analyses on filgotinib’s efficacy and safety profile at this year’s EULAR congress,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos.
  • “Our presence at EULAR underscores our firm commitment to develop transformational therapies to improve the lives of patients around the world.”
    A number of abstracts will present trial data analyses on filgotinib, a once-daily oral preferential JAK-1 inhibitor, for the treatment of moderate to severe active RA.
  • Furthermore, Galapagos is hosting a symposium: “JAK to reality: seeking clarity in RA”, which will focus on key considerations when selecting treatments for RA patients, efficacy and safety of JAK inhibitors, and the practical use of JAK inhibitors in the treatment of RA patients.
  • Distinct treatment responses in patients with rheumatoid arthritis receiving filgotinib 200 mg over 12 months: A post hoc analysis of FINCH 1
    What trade-offs are acceptable to rheumatoid arthritis patients during treatment selection?

Ulcerative Colitis Treatment Market to Grow Exponentially by 2029- Brandessence Market Research

Retrieved on: 
Thursday, May 18, 2023
MSD, Janus, Insurance, Prevalence, Interleukin 23, Abbott Laboratories, Enzyme, Diarrhea, Colon, Protein, Acquisition, Patient, Integrin, Eli Lilly and Company, Etrolizumab, Cell adhesion, Filgotinib, GSK plc, Pancolitis, Upadacitinib, USD, FMT, HIV disease progression rates, Allergan, Safety, GSK, Risankizumab, Mirikizumab, Takeda Pharmaceutical Company, Roche, MEA, Biomarker, Abdominal pain, Ulcerative colitis, UC, AbbVie, Cancer, Antibody, Bacillota, Johnson & Johnson, Sphingosine, Colitis, Module (mathematics), IL-12, TNF, JAK, Cramp, Pfizer, Inflammation, AstraZeneca, Eli Lilly, Ozanimod, Novartis, Cytokine, Health, Pharmaceutical industry, Dietary supplement, Vaccine, Health insurance, Bayer

The Global Ulcerative Colitis Treatment Market report curated by Brandessence Market Research provides a detailed overview of the market, including its size, growth rate, and key drivers.

Key Points: 
  • The Global Ulcerative Colitis Treatment Market report curated by Brandessence Market Research provides a detailed overview of the market, including its size, growth rate, and key drivers.
  • It examines various treatment options available for ulcerative colitis, including medications, surgery, and other therapies.
  • High Cost of Treatment: One of the major challenges in the ulcerative colitis treatment market is the high cost associated with the available treatment options.
  • FMT is being explored as a potential treatment option for ulcerative colitis, with ongoing clinical trials assessing its safety and efficacy.

Ulcerative Colitis Treatment Market to Grow Exponentially by 2029- Brandessence Market Research

Retrieved on: 
Thursday, May 18, 2023
MSD, Janus, Insurance, Prevalence, Interleukin 23, Abbott Laboratories, Enzyme, Diarrhea, Colon, Protein, Acquisition, Patient, Integrin, Eli Lilly and Company, Etrolizumab, Cell adhesion, Filgotinib, GSK plc, Pancolitis, Upadacitinib, USD, FMT, HIV disease progression rates, Allergan, Safety, GSK, Risankizumab, Mirikizumab, Takeda Pharmaceutical Company, Roche, MEA, Biomarker, Abdominal pain, Ulcerative colitis, UC, AbbVie, Cancer, Antibody, Bacillota, Johnson & Johnson, Sphingosine, Colitis, Module (mathematics), IL-12, TNF, JAK, Cramp, Pfizer, Inflammation, AstraZeneca, Eli Lilly, Ozanimod, Novartis, Cytokine, Health, Pharmaceutical industry, Dietary supplement, Vaccine, Health insurance, Bayer

The Global Ulcerative Colitis Treatment Market report curated by Brandessence Market Research provides a detailed overview of the market, including its size, growth rate, and key drivers.

Key Points: 
  • The Global Ulcerative Colitis Treatment Market report curated by Brandessence Market Research provides a detailed overview of the market, including its size, growth rate, and key drivers.
  • It examines various treatment options available for ulcerative colitis, including medications, surgery, and other therapies.
  • High Cost of Treatment: One of the major challenges in the ulcerative colitis treatment market is the high cost associated with the available treatment options.
  • FMT is being explored as a potential treatment option for ulcerative colitis, with ongoing clinical trials assessing its safety and efficacy.

Galapagos announces first quarter 2023 financial results

Retrieved on: 
Thursday, May 4, 2023
Linda, Galapagos NV, CD, CET, CD19, Chronic lymphocytic leukemia, PRAC, Baltic, Annual general meeting, Dermatomyositis, Patient, RT, Rheumatoid arthritis, CLL, Filgotinib, DM, Annual, Research, European Commission, Growth, IND, LTE, Safety, Exercise, Civil service commission, CRS, Medicine, SLE, Ulcerative colitis, UC, TYK2, Symantec Endpoint Protection, CFO, ICAN, Lupus, RA, JAK, NHL, ET, Euronext, Glen Burnie, Maryland, Pharmaceutical industry, Nursing, Management, Axial spondyloarthritis, Galápagos Islands, Central Europe, Romainville

Progress with immunology and oncology pipeline:

Key Points: 
  • Progress with immunology and oncology pipeline:
    Clinical sites opened to start patient recruitment in Phase 2 GALARISSO study with TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis (DM)
    Further expanding CAR-T point-of-care network in Europe, with IND filing in the US expected before year-end
    First quarter 2023 financial highlights:
    Webcast presentation tomorrow, 5 May 2023, at 14:00 CET / 8:00 am ET, www.glpg.com
    Mechelen, Belgium; 4 May 2023, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first quarter 2023 financial results, a year-to-date business update and its outlook for the remainder of 2023.
  • Within our pipeline, we presented encouraging initial Phase 1/2 results with GLPG5201, our CD19 CAR-T candidate in chronic lymphocytic leukemia.
  • In the first quarter of this year, Jyseleca® achieved €26.7 million in net sales in rheumatoid arthritis (RA) and ulcerative colitis (UC).
  • We continue to gain further insights into the market dynamics for the JAK class and we intend to revisit our 2023 net sales guidance at the next financial update in August.

Galapagos initiates Phase 3 program with filgotinib in patients with active axial spondyloarthritis

Retrieved on: 
Wednesday, April 26, 2023
Filgotinib, Galapagos NV, CET, Week, Rheumatology, Doctor of Philosophy, Ruhr University Bochum, EMA, Euronext, MD, Patient, Internal medicine, European Medicines Agency, Safety, Pharmaceutical industry, Axial spondyloarthritis, Galápagos Islands, Immunology

Mechelen, Belgium; 26 April 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was randomized in OLINGUITO, the pivotal Phase 3 program of filgotinib in AxSpA.

Key Points: 
  • Mechelen, Belgium; 26 April 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the first patient was randomized in OLINGUITO, the pivotal Phase 3 program of filgotinib in AxSpA.
  • We look forward to advancing the OLINGUITO program and to working collaboratively with our clinical partners.”
    The OLINGUITO global Phase 3 program ( NCT05785611 ) consists of two randomized, placebo-controlled, double-blind, multi-center, parallel-group studies.
  • Each study will enroll approximately 238 patients who are randomized 1:1 to receive filgotinib 200mg or placebo once-daily.
  • The double-blind studies will be followed by an open-label treatment period in which all patients will receive filgotinib 200mg once-daily up to Week 52.

Galapagos to present new data from long-term extension study of filgotinib in ulcerative colitis at annual ECCO congress 2023

Retrieved on: 
Monday, February 27, 2023
JAK, Safety, Cate, Doctor of Philosophy, Hugo, FRCPC, Filgotinib, CET, JAK1, Research, Anemia, Patient, LTE, Abstract, Quality of life (healthcare), Ulcerative colitis, RA, Rheumatoid arthritis, ECCO, European, Congress, Western University, Epidemiology, IBD, Galapagos NV, Euronext, Pharmaceutical industry, Biostatistics, MD, UC, Galápagos Islands, Immunology

A number of abstracts will present analyses from the SELECTION program with filgotinib.

Key Points: 
  • A number of abstracts will present analyses from the SELECTION program with filgotinib.
  • Additionally, Galapagos will present pooled data from five Phase 2/3 trials, and two long-term extension trials of filgotinib designed to further understand the safety profile of filgotinib in UC and rheumatoid arthritis (RA).
  • “We are excited to present data from multiple studies of filgotinib in UC, including results from the SELECTIONLTE study, which has been selected amongst the top 11 oral abstracts at ECCO,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, of Immunology, at Galapagos.
  • Amongst subjects who completed the study, the reduction in mean pMCS in SELECTION was maintained up to LTE Week 144.

Galapagos announces full year 2022 results and outlook for 2023

Retrieved on: 
Thursday, February 23, 2023
Real-World Evidence, JAK, Baltic, Civil service commission, CD19, Filgotinib, CET, UC, DM, Drug discovery, Collaboration, Patient, SLE, Exercise, Bank statement, Acceleration, BCMA, European Commission, TYK2, Depreciation, D, Multiple myeloma, Axial spondyloarthritis, Annual report, PRAC, Cryptocurrency, Pharmaceutical industry, Central Europe, EU

We reported product net sales of Jyseleca® in Europe in 2022 amounting to €87.6 million, compared to €14.8 million last year.

Key Points: 
  • We reported product net sales of Jyseleca® in Europe in 2022 amounting to €87.6 million, compared to €14.8 million last year.
  • Cost of sales related to Jyseleca® net sales in 2022 amounted to €12.1 million, compared to €1.6 million in 2021.
  • We also recognized royalty income from Gilead for Jyseleca® for €10.7 million in 2022 (compared to €3.8 million in 2021).
  • We aim to publish the fully audited annual report for the full year 2022 on, or around, 23 March 2023.