Mechelen

NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis

Retrieved on: 
Thursday, January 21, 2021
Specialty drugs, Gilead Sciences, Filgotinib, Biotechnology, Life sciences

Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration.

Key Points: 
  • Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration.
  • Filgotinib will be reviewed separately by the Scottish Medicines Consortium for use on the NHS in Scotland.
  • Under a new arrangement between Gilead and Galapagos, announced in December 2020, Galapagos will assume sole responsibility for filgotinib in Europe, including the UK.
  • Jyseleca, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

Gilead holds 25.54% of Galapagos shares

Retrieved on: 
Monday, January 11, 2021
Specialty drugs, Galapagos NV, Gilead Sciences, Biotechnology, Life sciences, Gilead, Galapagos, Companies

Mechelen, Belgium; 11 January 2021; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from Gilead Sciences, Inc.

Key Points: 
  • Mechelen, Belgium; 11 January 2021; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from Gilead Sciences, Inc.
    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 6 January 2021 from Gilead Sciences, Inc., who notified a change in the chain of intermediary companies through which Gilead holds its shares in Galapagos.
  • The change in the chain of intermediary companies is the result of an internal reorganization as a result of which Gilead holds its shares in Galapagos as of 31 December 2020 through its direct subsidiary Gilead Biopharmaceutics US, LLC, which through Gilead Sciences Ireland UC controls Gilead Therapeutics A1 Unlimited Company, which in turn holds 16,707,477 of Galapagos' voting rights, consisting of 16,707,477 shares (unchanged).
  • Those 16,707,477 shares represent 25.54% of Galapagos' currently outstanding 65,411,767 shares.
  • The full transparency notification is available on the Galapagos website.

Galapagos to present at 39th Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Wednesday, January 6, 2021
Communication, Forward-looking statement, Galapagos, Video games

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to dier materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them.

Key Points: 
  • This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to dier materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them.
  • These risks, uncertainties and other factors include, without limitation, the risk that ongoing and future clinical studies with Galapagos compounds may not be completed in the currently envisaged timelines or at all, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of Galapagos compounds due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties and that Galapagos estimations regarding its compounds development program and regarding the commercial potential of Galapagos compounds, may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2019 and our subsequent filings with the SEC.
  • All statements other than statements of historical fact are statements that could be deemed forward-looking statements.
  • The forward-looking statements contained herein are based on managements current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

Selvita completes acquisition of Fidelta from Galapagos

Retrieved on: 
Monday, January 4, 2021
Galapagos NV, Euronext, NASDAQ, Service companies, Companies, Financial markets

Mechelen, Belgium and Krakow, Poland 04 January 2021, 22.01 TIME CET Galapagos NV (Euronext & NASDAQ: GLPG) and Selvita S.A. (WSE: SLV) announced today that the strategic transaction in which Selvita has acquired Fidelta from Galapagos has been completed.

Key Points: 
  • Mechelen, Belgium and Krakow, Poland 04 January 2021, 22.01 TIME CET Galapagos NV (Euronext & NASDAQ: GLPG) and Selvita S.A. (WSE: SLV) announced today that the strategic transaction in which Selvita has acquired Fidelta from Galapagos has been completed.
  • Selvita has acquired 100% of the outstanding shares in Fidelta for an enterprise value of 31.2M plus the customary adjustments for net cash and working capital.
  • Acquisition of Fidelta substantially expands Selvitas integrated drug discovery services offering and strengthens its position as one of the largest preclinical contract research organizations in Europe.
  • Fidelta will now be fully consolidated under the Selvita Group, it will however continue to operate under the Fidelta name.

Galapagos’ CEO makes donation of €10 million in the form of personal shares to African Parks

Retrieved on: 
Wednesday, December 23, 2020
Onno, African Parks, Stolpe, Continents

The 10 million donation will be in the form of ordinary shares of Galapagos, donated by Mr. van de Stolpe to African Parks and spread over the coming five years.

Key Points: 
  • The 10 million donation will be in the form of ordinary shares of Galapagos, donated by Mr. van de Stolpe to African Parks and spread over the coming five years.
  • The first 2 million (25,150 ordinary shares held by Mr. van de Stolpe) have been transferred on 22 December 2020.
  • said Onno van de Stolpe: For me, African Parks is a very worthy cause to contribute to in order to make this happen.
  • We are extremely grateful to Onno in making this very generous commitment to African Parks, where our vision is to make the parks under our management ecologically, socially and financially sustainable, said Peter Fearnhead, CEO of African Parks.

Gilead  and  Galapagos  announce  New  Commercialization  and  Development  Agreement  for  Jyseleca®  (filgotinib)  

Retrieved on: 
Tuesday, December 15, 2020
Filgotinib, Royalty payment, Galápagos Islands, Galapagos NV

Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib.

Key Points: 
  • Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib.
  • In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialization in Europe.
  • Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA.
  • Under the terms of the new arrangement, Galapagos will assume all development, manufacturing, commercialization and certain other rights for filgotinib in Europe.

Galapagos increases share capital through subscription right exercises

Retrieved on: 
Friday, December 4, 2020
Galapagos NV, Business models, Onno van de Stolpe, Euronext, Onno, Subscription business model, NASDAQ, Companies, Service companies, Financial markets

Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.

Key Points: 
  • Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.
  • Galapagos issued 70,925 new ordinary shares on 4 December 2020, for a total capital increase (including issuance premium) of 2,615,857.50.
  • 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.

Galapagos announces first dosing in MANGROVE Phase 2 trial with GLPG2737 in polycystic kidney disease

Retrieved on: 
Tuesday, December 1, 2020
Kidney diseases, Medical specialties, Autosomal dominant polycystic kidney disease, Channelopathies, Clinical medicine, Medicine, Polycystic kidney disease, Galapagos NV, Polycystic disease, Placebo-controlled study

Mechelen, Belgium; 1 December 2020, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces first dosing in the new MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).

Key Points: 
  • Mechelen, Belgium; 1 December 2020, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces first dosing in the new MANGROVE Phase 2 trial with investigational CFTR inhibitor GLPG2737 in patients with autosomal dominant polycystic kidney disease (ADPKD).
  • MANGROVE is a randomized, double-blind, placebo-controlled trial evaluating a once-daily oral dose of GLPG2737.
  • The drug candidate or placebo will be administered for 52 weeks in up to 60 ADPKD patients with rapidly progressing disease.
  • GLPG2737 presents a potential opportunity for us in ADPKD, a disease with significant unmet need, added Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos.

Galapagos reports positive topline results with GLPG1205 in IPF patients in PINTA Proof-of-Concept trial 

Retrieved on: 
Monday, November 30, 2020
Clinical research, Design of experiments, Medical research, Health sciences, Health, Clinical trial, Placebo-controlled study, Randomized controlled trial, Pinta

The PINTA trial was a randomized, double-blind, placebo-controlled trial investigating a 100mg once-daily oral dose of GLPG1205.

Key Points: 
  • The PINTA trial was a randomized, double-blind, placebo-controlled trial investigating a 100mg once-daily oral dose of GLPG1205.
  • Based on the results of this trial, Galapagos plans to progress GLPG1205 in a dose finding Phase 2b trial.
  • The full results of the PINTA trial will be submitted to a future medical conference and peer-reviewed medical journals.
  • Keeping in mind the limitations of this early clinical study, the PINTA study with GLPG1205 is a positive trial.

Selvita to acquire Fidelta from Galapagos

Retrieved on: 
Monday, November 23, 2020
Galapagos NV, Euronext, Companies

Mechelen, Belgium and Krakow, Poland 23 November 2020, 22.15 CET Galapagos NV [Euronext & NASDAQ: GLPG] and Selvita S.A. [WSE: SLV] announced today that they have signed an agreement under which Selvita will acquire 100% of the outstanding shares in Fidelta d.o.o.

Key Points: 
  • Mechelen, Belgium and Krakow, Poland 23 November 2020, 22.15 CET Galapagos NV [Euronext & NASDAQ: GLPG] and Selvita S.A. [WSE: SLV] announced today that they have signed an agreement under which Selvita will acquire 100% of the outstanding shares in Fidelta d.o.o.
  • Fidelta is a contract research organization within the Galapagos Group of companies, with core scientific competences in inflammation, fibrosis, and anti-infectives.
  • Fidelta is located in state-of-the art R&D facilities in Zagreb, Croatia which offer almost 6,000 m2 of research space.
  • Upon completion of the acquisition, Fidelta will be fully consolidated under the Selvita Group, and will continue to operate under the Fidelta name.