Key Developments: Galapagos NV (GLPYY.PK)

GLPYY.PK on OTC Markets Group

9 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Galapagos initiates Phase 1 study with GLPG1690
Tuesday, 1 Jul 2014 01:31am EDT 

Galapagos NV:GLPG1690 molecule aimed at treating pulmonary diseases dosed in Phase 1 First-in-Human study.Company to receive 6.6 mln euros milestone payment from Janssen Pharmaceutica NV for this achievement.Phase 1 study aims to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1690.Randomized, double-blind, placebo-controlled, single center study is being conducted in at least 40 healthy volunteers in Belgium.  Full Article

Galapagos updates on products clinical trials
Tuesday, 17 Jun 2014 01:39am EDT 

Galapagos NV:Highlights progress and plans for its R&D program portfolio.Selective JAK1 inhibitor GLPG0634 shows positive profile in two rheumatoid arthritis Phase 2 studies.GLPG0634 is being trialled in global Phase 2b program (DARWIN) in 875 rheumatoid arthritis patients and Phase 2 study in 180 patients with Crohn's disease.GLPG0974 selective antagonist of FFA2 is to be tested in clinic.Four-week Phase 2 proof-of-concept study recently completed with GLPG0974 in 45 ulcerative colitis (UC) patients in 16 centers in four European countries.Multiple series of correctors showing better activity than VX-809 in pre-clinical tests in f508del mutation with GLPG1837 discovered by company and its partner AbbVie.Narrow spectrum antibiotic GLPG1492 expected to be dosed in first volunteers (Phase 1) in H2 2014.  Full Article

Galapagos NV announces management change
Monday, 28 Apr 2014 01:34am EDT 

Galapagos NV:Says Guillaume Jetten will resign as Chief Financial Officer of Galapagos, effective May 1.Laure Verhaegen, Vice President Finance, will act as interim CFO until a replacement has been recruited.  Full Article

Galapagos says GSK2586184 met primary endpoint in Phase 2a psoriasis study
Thursday, 17 Apr 2014 01:01am EDT 

Galapagos NV:Says GSK2586184 met primary endpoint in Phase 2a psoriasis study.Study JAK116679 was phase 2a multi-centre, randomised, double-blind, placebo-controlled, dose ranging study (100mg bid, 200mg bid, 400mg bid) that evaluated safety and efficacy of GSK2586184 compared with placebo in 66 patients with chronic plaque psoriasis.Preliminary results showed that significantly higher proportion of patients treated with GSK2586184 at 400mg bid dose met primary endpoint compared to placebo.Primary endpoint was defined as achieving >=75 pct improvement from baseline in Psoriasis Area Severity Index (PASI75) score at week 12.PASI75 for patients randomised to placebo was in range expected.During treatment period most common adverse events occurring with frequency of more than 20 pct on either placebo or pooled GSK2586184 were headache (36 pct placebo, 27 pct GSK2586184) and nasopharyngitis (21 pct placebo, 29 pct GSK2586184).  Full Article

Galapagos NV completes sale of BioFocus and Argenta service to Charles River Laboratories
Tuesday, 1 Apr 2014 01:45am EDT 

Galapagos NV:Confirms the completion of the transaction announced on March 13, 2014 to sell the BioFocus and Argenta service division operations to Charles River Laboratories International, Inc.Total consideration of up to 134 million euros.  Full Article

Galapagos confirms completion of BioFocus and Argenta divestiture
Tuesday, 1 Apr 2014 01:31am EDT 

Galapagos NV:Confirms completion of transaction announced on March 13 to sell BioFocus and Argenta service division operations to Charles River Laboratories International for up to 134 million euros.All closing conditions of definitive agreement have been met.Purchase price 129 million euros in cash, subject to certain post-closing working capital adjustments.Galapagos eligible to receive 5 million euros earnout payment after 12 months, upon achievement of revenue target for divested service division.  Full Article

Galapagos NV to present favorable pre-clinical data on GLPG1790, selective ephrin receptor kinase inhibitor, at AACR in San Diego
Tuesday, 18 Mar 2014 02:30am EDT 

Galapagos NV:Says will present favorable pre-clinical data on GLPG1790 in triple-negative breast cancer at American Association for Cancer Research (AACR) Annual Meeting in San Diego on 7 April 2014.Galapagos disclosed that GLPG1790 is first selective small molecule inhibitor of ephrin receptor kinase family, which could play key role in melanoma, pancreatic, ovarian, prostatic, and colorectal cancers, in addition to triple-negative breast cancer.Candidate drug GLPG1790 shows remarkable in vivo efficacy in triple negative breast cancer xenograft pre-clinical model.Full tumor blockage was observed after 30 mg/kg/d oral dosing, correlated with target inhibition in tumor.Extensive molecular mode of action studies, using GLPG1790 and knock-down tools, prove EPHA2 target engagement and impact on the MAPK pathway and cell cycle, important elements of the biology of many cancer types.GLPG1790 has good drug-like properties, and safety/tolerability studies with candidate drug look favorable.Galapagos is completing preclinical studies with GLPG1790, and is carefully considering a number of options before entering first clinical trials in humans.  Full Article

Charles River Laboratories International Inc to acquire the CRO Services Division of Galapagos NV
Thursday, 13 Mar 2014 02:45am EDT 

Charles River Laboratories International Inc:Enters into definitive agreement to acquire the CRO services division of Galapagos NV, which includes both Argenta and BioFocus.Purchase price is 129 mln Euros in cash.Transaction includes future performance payments of up to5 mln Euros.  Full Article

Galapagos NV gives FY 2014 outlook above analysts' estimates
Friday, 7 Mar 2014 01:37am EST 

Galapagos NV:Guides for 180 million euros in its 2014 revenues in 2014, representing 12.5 pct increase over 2013.FY 2014 revenue 169.14 million euros - Thomson Reuters I/B/E/S Estimates.  Full Article

Galapagos NV launches Proof of Concept study with GLPG0974
Monday, 17 Feb 2014 01:30am EST 

Galapagos NV:Announces that patient recruitment has been completed for the clinical Proof of Concept study with GLPG0974.Says GLPG0974 presents a new mode of action for the treatment of ulcerative colitis, a debilitating inflammatory bowel disease.Says the efficacy and safety of GLPG0974, which is fully proprietary to the company, are being evaluated during a 28-day treatment period.Says topline results from this study are expected in June.  Full Article

Biotech firm Galapagos ups 2014 cash guidance

BRUSSELS, Aug 8 - Belgian biotech group Galapagos on Friday said it expected to have more cash at the end of 2014 than initially thought, following the sale of a unit in the first half of the year.

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