Mechelen

Gilead Sciences submits new drug application in Japan for filgotinib for the treatment of ulcerative colitis with an inadequate response to conventional therapies

Retrieved on: 
Friday, April 23, 2021

No new safety risks were identified.\nUlcerative colitis is a chronic disease characterized by inflammation of the lining of the mucosa of the colon and rectum.

Key Points: 
  • No new safety risks were identified.\nUlcerative colitis is a chronic disease characterized by inflammation of the lining of the mucosa of the colon and rectum.
  • Even with treatment, defecation urgency, incontinence, recurrent bloody diarrhea, frequent bowel movements, abdominal pain, insomnia and fatigue are common.
  • Ulcerative colitis is one of the intractable\xc2\xa0diseases1 designated by the Ministry of Health, Labour and Welfare in Japan.
  • According to a nationwide survey, the estimated number of patients with ulcerative colitis in Japan in 2014 was 219,685.

Extension of lock-up period in Gilead-Galapagos collaboration agreement

Retrieved on: 
Thursday, April 8, 2021
Filgotinib

The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.

Key Points: 
  • The lock-up restrictions are subject to certain exceptions as provided in the share subscription agreement.
  • Commenting on the amendment, Gilead CFO Andrew Dickinson said, We remain strongly committed to our long-term collaboration.
  • Bart Filius, COO and President of Galapagos, added, The amendment announced today highlights Gileads commitment and support for our 10-year collaboration.
  • Gilead and Galapagos also have a collaboration for the development and commercialization of filgotinib, originally signed in 2015, with a new agreement announced in December 2020.

Publication of the annual report and invitation to the ordinary shareholders’ meeting

Retrieved on: 
Thursday, March 25, 2021
Articles, Corporate law, Committees, Board of directors, Business law, SEC filings, Business, Shareholders

The annual report for the financial year 2020, including a review of figures and performance, is available online at

Key Points: 
  • The annual report for the financial year 2020, including a review of figures and performance, is available online at
    https://www.glpg.com/financial-reports and can also be downloaded as PDF.
  • Our annual 2020 Form 20-F filing with the SEC is also available at www.sec.gov/edgar .
  • Furthermore, Galapagos has the honor to invite its shareholders, holders of subscription rights, board members, and statutory auditor to its annual (ordinary) shareholders meeting that will be held on Wednesday 28 April 2021 at 2:00 p.m. (CET) at the Companys registered office.
  • The convening notice and other documents pertaining to the shareholders meeting can be consulted on our website, www.glpg.com/shareholders-meetings .

Galapagos appoints Bart Filius as President and Chief Operating Officer

Retrieved on: 
Wednesday, March 24, 2021
Articles, Business, Transportation in California, Corporate governance, Chief operating officer, COO, Bay Area Rapid Transit

Mechelen, Belgium; 24 March 2021; 21.01 CET; Galapagos (Euronext & Nasdag; GLPG) announced today that its Supervisory Board has promoted Bart Filius to President and Chief Operating Officer (COO).

Key Points: 
  • Mechelen, Belgium; 24 March 2021; 21.01 CET; Galapagos (Euronext & Nasdag; GLPG) announced today that its Supervisory Board has promoted Bart Filius to President and Chief Operating Officer (COO).
  • Bart Filius joined Galapagos in 2014 as Chief Financial Officer and subsequently took on the responsibility as COO in 2017.
  • Prior to joining Galapagos, Bart spent 13 years at Sanofi, where he had leadership roles of increasing responsibility in finance, country management and M&A.
  • Bart Filius added, Im highly energized by the opportunity to lead Galapagos into the future, together with Onno and the Management Board.

Galapagos increases share capital through subscription right exercises

Retrieved on: 
Friday, March 19, 2021
Galapagos NV, Onno van de Stolpe, Business models, Euronext, Subscription business model, Onno, Companies, Marketing, Business

Mechelen, Belgium; 19 March 2021, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.

Key Points: 
  • Mechelen, Belgium; 19 March 2021, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.
  • Galapagos issued 99,814 new ordinary shares on 19 March 2021, for a total capital increase (including issuance premium) of 2,258,042.82.
  • 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 subscription rights, subject to certain conditions.
  • In accordance with the rules of this program, CEO Onno van de Stolpe exercised 15,000 subscription rights and in total he exercised 41,874 subscription rights.

GALAPAGOS REPORTS PRIMARY ENDPOINT FOR THE ONGOING FILGOTINIB MANTA AND MANTA-RAy SAFETY STUDIES

Retrieved on: 
Thursday, March 4, 2021
Clinical trials, Medical statistics, Clinical research, Medical research, Clinical endpoint, Filgotinib, Health

The primary endpoint in both trials was the proportion of patients who had a reduction of 50% or more in sperm concentration at Week 13.

Key Points: 
  • The primary endpoint in both trials was the proportion of patients who had a reduction of 50% or more in sperm concentration at Week 13.
  • Of those, 18 patients showed a 50% decline in sperm concentration, with 10/120 (8.3%) patients on placebo and 8/120 (6.7%) patients on filgotinib.
  • These studies, which were designed with the input of the relevant health authorities, are not powered for statistical comparison between groups.
  • The results of both studies have been pooled in the interim results of the primary endpoint.

Transparency notification received from The Capital Group

Retrieved on: 
Wednesday, March 3, 2021
Galapagos NV, NASDAQ, Euronext, Companies, Service companies, Financial markets, Galapagos NV, NASDAQ, Euronext, Companies, Service companies, Financial markets

Mechelen, Belgium; 3 March 2021; 22.15 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from The Capital Group Companies, Inc.

Key Points: 
  • Mechelen, Belgium; 3 March 2021; 22.15 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from The Capital Group Companies, Inc.
    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 26 February 2021 from The Capital Group Companies, Inc., who notified that it holds 9.91% of the current 65,411,767 outstanding Galapagos shares.
  • The Capital Group Companies, Inc. thus crossed below the 10% threshold of Galapagos voting rights by disposing of voting securities on 22 February2021.
  • The full transparency notice is available on the Galapagos website.
  • Capital Group controls Capital Bank & Trust Company and Capital Research & Management Company through its direct subsidiary Capital Group International, Inc. (CGII), controls four CGII investment management companies (Capital International, Inc.; Capital International Limited, Capital International Srl; and Capital International K.K.

Pipeline and capital for growth

Retrieved on: 
Thursday, February 18, 2021
HeadCount, Voter registration, Royalty payment

Our revenues and other income from continuing operations for 2020 amounted to 530.3 million, compared to 885.8 million in 2019.

Key Points: 
  • Our revenues and other income from continuing operations for 2020 amounted to 530.3 million, compared to 885.8 million in 2019.
  • Additionally we have recognized royalty income from Gilead for Jyseleca for 16.2 million.
  • Furthermore, personnel costs increased, explained by a planned headcount increase following the growth in our R&D investments, and increased cost of the subscription right plans.
  • We anticipate a year filled with announcements on regulatory developments with Jyseleca as well as progress in our deep pipeline of novel target-based candidates.

Galapagos and Gilead discontinue ISABELA Phase 3 trials in IPF

Retrieved on: 
Wednesday, February 10, 2021
Articles, Communication, Forward-looking statement, Health sciences, Statement, Clinical trial, Causality

These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

Key Points: 
  • These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.
  • The reader is cautioned not to rely on these forward-looking statements.
  • All statements other than statements of historical fact are statements that could be deemed forward-looking statements.
  • Ziritaxestat is investigational; its efficacy and safety have not been fullyevaluated by anyregulatory authority and it is not yet approved for any use outside of clinical trials.

The Capital Group holds 10.03% of Galapagos shares

Retrieved on: 
Tuesday, February 9, 2021
Galapagos NV, Euronext, NASDAQ, Service companies, Companies, Financial markets

Mechelen, Belgium; 9 February 2021; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from The Capital Group Companies, Inc.

Key Points: 
  • Mechelen, Belgium; 9 February 2021; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from The Capital Group Companies, Inc.
    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 5 February 2021 from The Capital Group Companies, Inc., that it holds 10.03% of the current 65,411,767 outstanding Galapagos shares.
  • The Capital Group Companies, Inc. thus crossed above the 10% threshold of Galapagos voting rights by purchase of voting securities on 22 January2021.
  • Capital Group controls Capital Bank & Trust Company and Capital Research & Management Company through its direct subsidiary Capital Group International, Inc. (CGII), controls four CGII investment management companies (Capital International, Inc.; Capital International Limited, Capital International Srl; and Capital International K.K.
  • ), which all together hold 6,563,320 of Galapagos voting rights, consisting of ordinary shares (6,559,874) and equivalent financial instruments (right to recall lent American Depository Shares) (3,446), which represents 10.03%.