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Last $52.40 USD
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Volume 0.0
GLPGF On Other Exchanges
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As of 4:30 PM 06/29/15 All times are local (Market data is delayed by at least 15 minutes).

galapagos nv (GLPGF) Snapshot

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05/29/15 - $57.25
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galapagos nv (GLPGF) Details

Galapagos NV, a clinical stage biotech company, develops and commercializes novel medicines in Belgium, Croatia, France, and the Netherlands. Its products include GLPG0634, an orally-available selective inhibitor of Janus kinase 1, which is in Phase II clinical study for the treatment of rheumatoid arthritis and other inflammatory diseases; and GLPG1205/GLPG1690 that is in Phase IIA clinical study for treating inflammatory bowel disease, as well as in Phase II proof-of-concept study for the treatment of ulcerative colitis patients. The company is also developing MOR106, an antibody, which is in preclinical development stage for the treatment of inflammatory diseases; GSK2586184, an investigational compound that is in Phase II clinical study for the treatment of chronic immuno-inflammatory diseases consisting of SLE, psoriasis, and ulcerative colitis; and GLPG0974, an orally available small molecule, which is in Phase II clinical study to prevent free fatty acid-induced activation and migration of neutrophils towards an inflammatory site, such as in the gut of patients with inflammatory bowel disease. It has strategic alliances with GlaxoSmithKline, MorphoSys, Servier, and AbbVie to discover and develop small molecules for the treatment of inflammation, inflammatory diseases, osteoarthritis, oncology, rheumatoid arthritis/crohn’s disease, and cystic fibrosis diseases. The company was founded in 1999 and is headquartered in Mechelen, Belgium.

410 Employees
Last Reported Date: 08/6/15
Founded in 1999

galapagos nv (GLPGF) Top Compensated Officers

Co-Founder, Chief Executive Officer, Managing...
Total Annual Compensation: €696.5K
Compensation as of Fiscal Year 2014.

galapagos nv (GLPGF) Key Developments

Galapagos NV Announces JAK1 Inhibitor Filgotinib Results

Galapagos NV announced that the selective JAK1 inhibitor filgotinib as once-daily monotherapy at week 24 showed further improvements in signs and symptoms of moderately to severe, active rheumatoid arthritis (RA) in the DARWIN 2 Phase 2B study. Filgotinib was well tolerated in this study. Hemoglobin levels increased. These final 24-week study results are consistent with the efficacy and safety profile of filgotinib observed in prior clinical studies. With these final results, the data package for AbbVie is complete, which triggers the start of the licensing decision period. DARWIN 2 is a 24-week, double-blind, placebo-controlled evaluation of filgotinib, as once-daily administration (QD dosing) at 3 dose levels. Results were reported for 283 patients with moderate to severe rheumatoid arthritis who showed an inadequate response to methotrexate. Filgotinib or placebo was given as monotherapy. The patients were evaluated up to 24 weeks. The results from this study show a rapid onset of efficacy, as of week 1 for ACR and DAS28(CRP) responses. Maximum ACR20 and ACR50 responses were obtained at week 8 and week 12 respectively. Additional gain was reported for ACR70 and DAS28(CRP) during the second half of the study. In the dose groups, up to 50% of the patients reached low disease activity or remission. The 100 mg and 200 mg QD doses achieve similar levels of efficacy. Over all dose groups including placebo, 3.9% of patients stopped treatment during the study for safety reasons. A higher discontinuation rate for safety was observed for placebo (5.6%) during the first 12 weeks of the study compared to filgotinib treated patients (2.5%) up to week 24. Similar incidence of serious and non-serious treatment-emergent adverse events was reported, evenly spread over the dose groups including placebo. A higher rate of infections was observed in filgotinib (19% over 24 weeks) compared to placebo (10% up to week 12), with serious infections remaining limited (1.4% of filgotinib patients). No malignancies, TB, MACE, opportunistic infections, or death were reported. Consistent with its selective JAK1 inhibition, filgotinib treatment led to an improvement in hemoglobin (up to 0.4 g/dL, or 3.6% increase from baseline). Neutrophil levels remained stable after initial decline to mid-normal range at week 4. There was no impact on lymphocytes or liver function tests. The similar increases in LDL and HDL were maintained.

Galapagos NV - Special Call

To discuss selective JAK1 inhibitor filgotinib as once-daily monotherapy at week 24 showed further improvements in signs and symptoms of moderately to severe, active rheumatoid arthritis (RA) in the DARWIN 2 Phase 2B study

Galapagos NV Completes Patient Recruitment in FITZROY Phase 2 Crohn's Disease Study with Filgotinib

Galapagos NV announced that the last patient has been randomized in the FITZROY Phase 2 clinical study. The study evaluates the efficacy and safety of filgotinib, a selective JAK 1 inhibitor, during 20 weeks of treatment in 175 patients with Crohn's disease. Galapagos is eligible to receive $50 million fee from AbbVie if AbbVie elects to in-license filgotinib after receipt of the full RA DARWIN 1 and 2 data and elects to move forward with filgotinib in Crohn's disease. Filgotinib is the first selective JAK1 inhibitor in development for Crohn's disease. The innovative design of the Phase 2 study with filgotinib evaluates induction of disease remission and explores early maintenance of its beneficial effects, potentially enabling a rapid entry into Phase 3 studies. Galapagos funded and conducted the Phase 2 study, recruiting patients with active Crohn's disease in 66 clinical centers in 9 countries throughout Western and Eastern Europe. Galapagos expects to announce topline primary endpoint results following 10 weeks of treatment in December 2015, with 20 weeks results expected in first quarter of 2016. The Phase 2 study in Crohn's disease is being performed in parallel with the DARWIN Phase 2B program for filgotinib in rheumatoid arthritis (RA). Galapagos expects to report final 24-week data from the second DARWIN study, evaluating filgotinib in a monotherapy setting, in August 2015. AbbVie has the exclusive right to license filgotinib upon its receipt of the final data package from the Phase 2B RA studies. In the event that AbbVie in-licenses filgotinib following receipt of the full data package from the DARWIN 1 and DARWIN 2 Phase 2B studies in RA, Galapagos will also be eligible to receive an additional $50 million payment if AbbVie elects to move forward with filgotinib in Crohn's disease after receipt of the complete data set from the Crohn's study.

 

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