GLPG Galapagos NV

55.64
+0.35  (+1%)
Previous Close 55.29
Open 55.57
52 Week Low 54.55
52 Week High 148.68
Market Cap $3,645,673,068
Shares 65,522,521
Float 65,469,108
Enterprise Value $-2,268,795,768
Volume 293,991
Av. Daily Volume 353,751
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Upcoming Catalysts

Drug Stage Catalyst Date
GLPG3667
Plaque Psoriasis
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Filgotinib - DIVERSITY
Crohn’s disease
Phase 3
Phase 3
Phase 3 enrolment to be completed in 2021.
GLPG3970 (LADYBUG)
Rheumatoid Arthritis
Phase 2a
Phase 2a
Phase 2a data released July 14, 2021 - showed no differentiation from placebo.
GLPG3970 (SEA TURTLE)
Ulcerative Colitis
Phase 2
Phase 2
Phase 2 data released July 14, 2021. No differentiation from placebo.
GLPG3970 (CALOSOMA)
Psoriasis
Phase 1b
Phase 1b
Phase 1b data released July 14, 2021. 4/13 patients exhibited a response at Week 6.
GLPG1690 - NOVESA
Systemic sclerosis
Phase 2
Phase 2
Phase 2 trial met primary endpoint - September 10, 2020.
Filgotinib PENGUIN
Psoriatic arthritis
Phase 3
Phase 3
Phase 3 trial paused - October 28, 2020.
Filgotinib (MANTA)
Inflammatory Bowel Disease
Phase 2
Phase 2
Phase 2 interim data released March 4, 2021.
Filgotinib
Non-infectious uveitis
Phase 2
Phase 2
Phase 2 trial enrolment has been paused due to COVID-19.
Filgotinib
Rheumatoid arthritis (RA)
CRL
CRL
CRL announced August 18, 2020. FDA approval will not be pursued - announced December 15, 2020.
GLPG2737 (MANGROVE)
Autosomal dominant polycystic kidney disease (ADPKD)
Phase 2
Phase 2
Phase 2 initiation of dosing announced December 1, 2020.
GLPG1205 - PINTA
Idiopathic pulmonary fibrosis (IPF)
Phase 2
Phase 2
Phase 2 data released November 30, 2020 - forced vital capacity (FVC) decline of 42mL across treatment groups at 26 weeks. Phase 2b trial planned.
Filgotinib - TORTUGA
Ankylosing spondylitis
Phase 2
Phase 2
Phase 3 enrolment on hold.
GLPG1972 - ROCCELLA
Osteoarthritis
Phase 2b
Phase 2b
Phase 2 trial did not meet primary endpoint - October 15, 2020.
Filgotinib - SELECTION
Ulcerative colitis
Phase 2/3
Phase 2/3
Phase 2b/3 data released May 20, 2020. 200mg dose met primary endpoint. 100mg did not meet clinical remission endpoint.
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.
GLPG1837
Cystic Fibrosis
Phase 2
Phase 2
Phase 2 top-line data released December 20, 2016.

Latest News

  1. Mechelen, Belgium; 17 September 2021; 13.15 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year.

    The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated…

    Mechelen, Belgium; 17 September 2021; 13.15 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year.

    The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The trial was recently published in The Lancet1.

    Dr Walid Abi-Saab, Chief Medical Officer at Galapagos, said: "Ulcerative colitis can have significant and profound effects on the people who suffer with the condition. Persistent inflammation and uncontrolled disease mean patients may experience debilitating relapses, may need increasing doses of steroids and in some instances may require surgery, which impacts them not only physically, but also psychologically. Today's decision brings us one step closer to providing a new treatment option for people living with this chronic disease."   

    The CHMP positive opinion will now be reviewed by the European Commission and a decision is expected before year end 2021. This positive opinion follows the previous approval of filgotinib for the treatment of patients with moderate to severe active rheumatoid arthritis. The use of filgotinib for UC is investigational and is not approved anywhere globally.

    About Ulcerative Colitis  

    Ulcerative colitis (UC) is a debilitating inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2 million people2 are affected by IBD, which includes UC and Crohn's Disease (CD). UC is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a significant psychological impact associated with UC. It causes significant impairments on quality of life and a poor prognosis is often seen in patients with symptoms of moderate to severe UC at diagnosis.

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The individual Great Britain and Northern Ireland Summary of Product Characteristics can be found at www.medicines.org.uk/emc and www.emcmedicines.com/en-GB/northernireland, respectively. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe, Great-Britain and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    1. Feagan. B., et al: Filgotinib as induction and maintenance therapy for ulcerative colitis: the SELECTION trial. The Lancet https://doi.org/10.1016/S0140-6736(21)00666-8.
    2. Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    Evelyn Fox

    Director Executive Communications 

    +31 65 3591 999 

    communications@glpg.com

    Forward-looking statements

    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 differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These forward-looking statements include statements concerning the timing and outcome of a final decision by the European Commission and statements concerning the safety, efficacy and commercial potential of filgotinib. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the filgotinib clinical program, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development in UC or other indications due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 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 management's 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.

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  2. Mechelen, Belgium; 30 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) announces the planned retirement of CEO Onno van de Stolpe.

    Onno van de Stolpe co-founded Galapagos in 1999 and built and led the company as CEO from its early R&D days through to the commercial launch of Jyseleca® (filgotinib) in Europe. Onno will retire and make way for a new CEO to lead the company going forward; he plans to stay on as CEO until a successor is appointed. The Supervisory Board has initiated an external search for his replacement.

    "Over the last 20 years, Onno has built one of the most important biotechnology companies in Europe, guiding it from a new start-up to a public company that recently launched…



    Mechelen, Belgium; 30 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) announces the planned retirement of CEO Onno van de Stolpe.

    Onno van de Stolpe co-founded Galapagos in 1999 and built and led the company as CEO from its early R&D days through to the commercial launch of Jyseleca® (filgotinib) in Europe. Onno will retire and make way for a new CEO to lead the company going forward; he plans to stay on as CEO until a successor is appointed. The Supervisory Board has initiated an external search for his replacement.

    "Over the last 20 years, Onno has built one of the most important biotechnology companies in Europe, guiding it from a new start-up to a public company that recently launched its first approved medicine. The Supervisory Board is deeply grateful to Onno for his years of dedication and leadership, and for creating an enduring organization," said Dr. Raj Parekh, Chairman of the Supervisory Board of Galapagos.

    "My time at the helm of Galapagos will come to an end. We have built a great company that bridges novel target discovery all the way to new medicines in the clinic and to the patient. Despite recent setbacks, we continue to progress a deep pipeline of novel target-based compounds, while the commercial roll-out of our first approved product is underway. With our strong balance sheet and long-term R&D collaboration with Gilead, I am confident that the company is well positioned to grow again from here," said Onno van de Stolpe, CEO.

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain's Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Carmen Vroonen 

    Global Head of Communications and Public Affairs 

    +32 473 82 48 74  

    Evelyn Fox

    Director Executive Communications

    +31 6 53 59 19 99

    communications@glpg.com

    Forward-looking statements

    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 differ 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 inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for RA, UC or any other indication, such regulatory authorities requiring additional studies, changes in our management board and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment of a suitable successor to lead our organization, the risk that Galapagos will be unable to successfully achieve the anticipated benefits from its leadership transition plan, the possibility that Galapagos will encounter challenges retaining or attracting talent, the risk that Galapagos will not be able to continue to execute on its business plan, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio, and potential changes of such ambitions, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), the uncertainties relating to the impact of the COVID-19 pandemic and our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 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 management's 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.



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    • First half-year 2021 financial results:
      • Group revenues and other income of €277.2 million
      • Operating loss of €97.6 million
      • Net loss of €55.0 million
      • Cash and current financial investments of €5.0 billion on 30 June 2021
    • Advancing refocused pipeline; encouraging clinical read-outs reported in earlier-stage inflammatory programs
    • Commercial launch of filgotinib in Europe on track
    • Executing on operational restructuring and savings program

    Webcast presentation tomorrow, 6 August 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 8245817

    Mechelen, Belgium; 5 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &amp, NASDAQ:GLPG) is pleased to report progress on earlier-stage programs as well as its commercial launch

    • First half-year 2021 financial results:
      • Group revenues and other income of €277.2 million
      • Operating loss of €97.6 million
      • Net loss of €55.0 million
      • Cash and current financial investments of €5.0 billion on 30 June 2021
    • Advancing refocused pipeline; encouraging clinical read-outs reported in earlier-stage inflammatory programs
    • Commercial launch of filgotinib in Europe on track
    • Executing on operational restructuring and savings program

    Webcast presentation tomorrow, 6 August 2021, at 14.00 CET / 8 AM ET, www.glpg.com, +32 2 793 38 47, code 8245817

    Mechelen, Belgium; 5 August 2021, 22.01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) is pleased to report progress on earlier-stage programs as well as its commercial launch of filgotinib in Europe. Following recent setbacks, the company is moving forward with its revised strategy and operational restructuring announced in May. The unaudited H1 financial and operational results are further detailed in the H1 2021 report available on the website, www.glpg.com.

    "Multiple assets are moving through clinical development, and we recently reported positive topline data on our TYK2 compound GLPG3667. In a Phase 1b trial in psoriasis (Pso), clinical activity was observed at 4 weeks, combined with an encouraging safety and tolerability profile. We currently are running an extended dose escalation study in healthy volunteers, and plan to progress GLPG3667 to a Phase 2b dose finding study in Pso as well as a Phase 2 study in ulcerative colitis (UC) in 2022.

    We continue to develop our SIK portfolio of molecules, and recently reported encouraging early data from the first patient studies with SIK2/3 inhibitor GLPG3970. In a Phase 1b trial in Pso (CALOSOMA), clinical activity was observed at 6 weeks, and in a Phase 2a trial in UC (SEA TURTLE), biologically important effects were observed on a number of objective endpoints, both of which point to the potential of SIK inhibition as a novel mode of action in inflammation. No activity was observed in the LADYBUG study in rheumatoid arthritis (RA). GLPG3970 was generally safe and well tolerated. Based on these encouraging data, we work on optimizing the pharmacology of follow-up compounds from our SIK portfolio, and plan to bring an improved SIK2/3 molecule into the clinic in 2022.

    On the commercial side, we report rapid progress in establishing our commercial operations for Jyseleca across Europe, with 11 countries launched to date. Reimbursement procedures are on track, and we are on target to achieve our commercial objectives.

    We remain excited about the potential of our target discovery platform, our drug development capabilities, and the strength of our teams. We want to thank our shareholders for their continued support and patience as we are working hard to build our pipeline and establish Galapagos as a fully integrated European biopharma," said Onno van de Stolpe, CEO of Galapagos.

    Bart Filius, President and COO, added, "Following the strategic exercise announced at Q1, we are focused on advancing our pipeline, implementing our savings program, and diligently evaluating business development opportunities. At the same time, we have been delivering on the launch of Jyseleca, building out our organization in new European markets. In line with our review, we reiterate our 2021 operational cash burni guidance of between €580 million and €620 million. We believe that the decisions and actions taken put us on the strongest footing for the future. We look forward to a busy second half of the year, not the least of which is the expected outcome of the regulatory review in Europe of Jyseleca in UC."

    Key figures first half-year report 2021 (unaudited)

    (€ millions, except basic & diluted loss per share)

      30 June 2021 group total 30 June 2020 group total (*)
    Revenues and other income 277.2 217.2
    R&D expenditure (268.8) (262.9)
    G&Aii and S&Miii expenses (106.0) (88.7)
    Operating loss (97.6) (134.4)
    Fair value re-measurement of financial instruments 2.8 (21.1)
    Net other financial result 17.1 (13.0)
    Income taxes



     
    0.5 (0.7)
    Net loss from continuing operations (77.2) (169.2)
    Net profit from discontinued operations 22.2 3.6
    Net loss of the period (55.0) (165.6)
    Basic and diluted loss per share (€) (0.84) (2.55)
         
    Current financial investments and cash and cash equivalents 5,006.6 5,566.5

    (*) The 2020 comparatives have been restated to consider the impact of classifying the Fidelta business as discontinued operations in 2020.

    Details of the financial results

    Due to the sale of our fee-for-service business (Fidelta) to Selvita on 4 January 2021 for a total consideration of €37.1 million (including customary adjustments for net cash and working capital), the results of Fidelta are presented as "Net profit from discontinued operations" in our unaudited condensed consolidated income statements for the six months ended 30 June 2021 and 30 June 2020.

    Revenues and other income from continuing operations

    Our revenues and other income from continuing operations for the first six months of 2021 increased to €277.2 million compared to €217.2 million in the first six months of 2020. Our revenues from the Gilead collaboration in the first six months of 2021 (€253.2 million) related to (i) the exclusive access to our drug discovery platform (€115.7 million), (ii) the filgotinib revenue recognition (€136.1 million) and (iii) royalties (€1.4 million).

    Our deferred income balance on 30 June 2021 includes €1.9 billion allocated to our drug discovery platform that is recognized linearly over 10 years, and €0.7 billion allocated for the filgotinib development (including considerations for the previous and the renegotiated collaboration combined) that is recognized over time until the end of the development period.

    Results from continuing operations

    We realized a net loss from continuing operations of €77.2 million for the first six months of 2021, compared to a net loss of €169.2 million for the first six months of 2020.

    We reported an operating loss amounting to €97.6 million for the first six months of 2021, compared to an operating loss of €134.4 million for the same period last year.

    Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the osteoarthritis (OA) program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106. Personnel costs increased due to an increase in headcount compared to the same period last year and increased costs of our subscription right plans. This factor, and the increased cost of the commercial launch of filgotinib in Europe, contributed to the increase in our S&M and G&A expenses, which were respectively €29.1 million and €76.9 million in the first six months of 2021, compared to respectively €26.9 million and €61.8 million in the first six months of 2020. 

    We reported a non-cash fair value gain from the re-measurement of initial warrant B issued to Gilead, amounting to €2.8 million, mainly due to the decreased implied volatility of the Galapagos share price and its evolution between 31 December 2020 and 30 June 2021.

    Net other financial income in the first six months of 2021 amounted to €17.1 million, compared to net other financial loss of €13.0 million for the first six months of 2020, which was primarily attributable to €33.4 million of currency exchange gain on our cash and cash equivalents and current financial investments in U.S. dollars, to €8.7 million of negative changes in (fair) value of current financial investments and financial assets and to €4.4 million of interest expenses. The other financial expenses also contained the effect of discounting our long term deferred income of €4.8 million.

    Results from discontinued operations

    The net profit from discontinued operations for the six months ended 30 June 2021 consisted of the gain on the sale of Fidelta, our fee-for-services business, for €22.2 million.

    Group net results

    We reported a group net loss for the first six months of 2021 of €55.0 million, compared to a group net loss of €165.6 million for the first six months of 2020.

    Cash position

    Current financial investments and cash and cash equivalents totaled €5,006.6 million on 30 June 2021, as compared to €5,169.3 million on 31 December 2020.

    Total net decrease in cash and cash equivalents and current financial investments amounted to €162.7 million during the first six months of 2021, compared to a net decrease of €214.3 million during the first six months of 2020. This net decrease was composed of (i) €223.2 million of operational cash burn, (ii) offset by €2.6 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2021, (iii) €5.8 million negative changes in (fair) value of current financial investments and €35.0 million of mainly positive exchange rate differences, (iv) €28.7 million cash in from disposal of subsidiaries, net of cash disposed.

    Finally, our balance sheet on 30 June 2021 held a receivable from the French government (Crédit d'Impôt Rechercheiv) and a receivable from the Belgian Government for R&D incentives, for a total of both receivables of €142.7 million.

    Outlook 2021

    In 2021, we expect the European regulatory assessment of filgotinib for the treatment of UC and anticipate both an opinion from the Committee for Medicinal Products for Human Use (CHMP) and a decision from the European Commission later this year. We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year.

    Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in Crohn's disease by our collaboration partner Gilead is also expected later this year.

    With regard to our SIK portfolio, we are advancing our SIK3 inhibitor GLPG4399 in healthy volunteers this year, and we aim to advance a follow-up SIK2/3 preclinical candidate into the clinic in 2022.

    Following the positive topline data from our TYK2 inhibitor, GLPG3667, we currently are running an extended dose escalation study in healthy volunteers, and we are preparing for a Phase 2b trial in Pso and a Phase 2 trial in UC next year.

    In our other programs, by year-end we intend to finalize recruitment into the GLPG2737 Phase 2a trial in polycystic kidney disease.

    Following the previously announced review of our plans for 2021, we reiterate our guidance for full year 2021 operational cash burn of €580 to €620 million.

    First half-year report 2021

    Galapagos' financial report for the first half-year ended 30 June 2021, including details of the unaudited consolidated results, is accessible via www.glpg.com/financial-reports.

    Conference call and webcast presentation

    Galapagos will conduct a conference call open to the public tomorrow, 6 August 2021, at 14:00 CET / 8 AM ET, which will also be webcasted. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

    CODE: 8245817

    Standard International: +44 (0) 2071 928338
    USA: +1 646 741 3167
    UK: +44 844 481 9752
    Netherlands: +31 207 95 66 14
    France: +33 1 70 70 0781
    Belgium: +32 2 793 38 47

    A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

    Financial calendar

    4 November 2021 Third quarter 2021 results (webcast 5 November 2021)
    24 February 2022 Full year 2021 results (webcast 25 February 2022)

    About Galapagos

    Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    Except for filgotinib's approval for the treatment of rheumatoid arthritis by the European Commission, Great Britain's Medicines and Healthcare products Regulatory Agency and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

    Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

    Contact

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    Sandra Cauwenberghs

    Director Investor Relations

    +32 495 58 46 63

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    communications@glpg.com

    Forward-looking statements

    This release may contain forward-looking statements, including, among other things, statements regarding the global R&D collaboration with Gilead, the amount and timing of potential future milestones, opt-in and/or royalty payments by Gilead, Galapagos' strategic R&D ambitions, including progress on our fibrosis portfolio and Toledo platform, and potential changes of such ambitions, the guidance from management (including guidance regarding the expected operational use of cash during financial year 2021), financial results, statements regarding the expected timing, design and readouts of ongoing and planned clinical trials, including recruitment for trials and topline results for our trials and studies in our inflammation portfolio, statements regarding the strategic re-evaluation, statements relating to interactions with regulatory authorities, the timing or likelihood of additional regulatory authorities' approval of marketing authorization for filgotinib for RA, UC or any other indication, including UC and IBD indication for filgotinib in Europe, Great-Britain, Japan, and the U.S., such additional regulatory authorities requiring additional studies, the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the build-up of our commercial organization, statements and expectations regarding commercial sales for filgotinib, the expected impact of COVID-19, and our strategy, business plans and focus. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that our expectations regarding our 2021 revenues and financial results and our 2021 operating expenses may be incorrect (including because one or more of its assumptions underlying its expense expectations may not be realized), Galapagos' expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including the risk that data from Galapagos' ongoing and planned clinical research programs in rheumatoid arthritis, Crohn's disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, other inflammatory indications and kidney disease may not support registration or further development of its product candidates due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including our collaboration partner Gilead), the timing of and the risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, estimating the commercial potential of our product candidates and Galapagos' expectations regarding the costs and revenues associated with the transfer of European commercialization rights to filgotinib may be incorrect, and the uncertainties relating to the impact of the COVID-19 pandemic. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.


    i The operational cash burn (or operational cash flow if this performance measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:

    1. the net proceeds, if any, from share capital and share premium increases included in the net cash flows generated from/used in (-) financing activities
    2. the net proceeds or cash used, if any, in acquisitions or disposals of businesses; the movement in restricted cash and movement in current financial investments, if any, included in the net cash flows generated from/used in (-) investing activities.

    This alternative performance measure is in our view an important metric for a biotech company in the development stage.

    The operational cash burn for the six months ended 30 June 2021 amounted to €223.2 million and can be reconciled to our cash flow statement by considering the increase in cash and cash equivalents of €477.4 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €2.6 million, (ii) the net sale of current financial investments amounting to €669.4 million, and (iii) the cash in from sale of subsidiaries, net of cash disposed, of €28.7 million.   

    ii General and administrative

    iii Sales and marketing

    iv Crédit d'Impôt Recherche refers to an innovation incentive system underwritten by the French government



     

     

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    • Biologic effect of salt inducible kinase (SIK) mechanism in first patient studies supports further progression of Toledo portfolio
    • SIK2/3 inhibitor GLPG3970 generally safe and well-tolerated
    • Study in psoriasis patients shows improvement in PASI score at Week 6
    • Study in ulcerative colitis (UC) patients shows signs of biologically important effects; does not translate to signal on Mayo score at Week 6
    • No signal observed in rheumatoid arthritis (RA) study at Week 6

    Mechelen, Belgium; 14 July 2021; 22.01 CET; regulated informationGalapagos NV (Euronext & Nasdaq: GLPG) reports topline results with GLPG3970 in three patient studies. GLPG3970, the first product candidate from a broad portfolio of SIK inhibitor compounds, provides clinical data supporting

    • Biologic effect of salt inducible kinase (SIK) mechanism in first patient studies supports further progression of Toledo portfolio
    • SIK2/3 inhibitor GLPG3970 generally safe and well-tolerated
    • Study in psoriasis patients shows improvement in PASI score at Week 6
    • Study in ulcerative colitis (UC) patients shows signs of biologically important effects; does not translate to signal on Mayo score at Week 6
    • No signal observed in rheumatoid arthritis (RA) study at Week 6



    Mechelen, Belgium; 14 July 2021; 22.01 CET; regulated informationGalapagos NV (Euronext & Nasdaq: GLPG) reports topline results with GLPG3970 in three patient studies. GLPG3970, the first product candidate from a broad portfolio of SIK inhibitor compounds, provides clinical data supporting the role of SIK inhibition in inflammation. SIK is a novel target class discovered by Galapagos.

    Galapagos evaluated GLPG3970, a proprietary salt inducible kinase (SIK) 2/3 inhibitor, in three randomized, placebo-controlled, double-blind studies: a Phase 1b study in patients with moderate to severe psoriasis and two Phase 2a studies in patients with moderate to severely active UC and RA. GLPG3970 or placebo were administered orally once-daily for 6 weeks. Main objectives were to evaluate the safety and tolerability of GLPG3970 as well as early signs of biologic and clinical effect.

    Across the three studies, GLPG3970 was generally safe and well tolerated. There were no deaths nor serious adverse events, and the majority of treatment emergent adverse events (TEAEs) were mild or moderate in nature.

    CALOSOMA study: Phase 1b trial in psoriasis

    This study randomized 26 patients with moderate to severe psoriasis in a 3:2 ratio, GLPG3970 to placebo. Two out of 15 patients discontinued in the treatment arm (COVID-19 and pruritus) versus 1 out of 11 on placebo (psoriatic arthropathy). 

    At Week 6, four out of 13 patients on GLPG3970 had a PASI1 50 response, defined as at least a 50% improvement of baseline PASI, compared to none on placebo. Specifically, the four responders achieved 50%, 50%, 56%, and 77% improvement in their PASI scores from baseline, reaching statistical significance compared to placebo (p=0.002) at Week 6. Positive signals of clinical effect were also consistently observed for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at Week 6.

    SEA TURTLE study: Phase 2a trial in UC

    This study randomized 31 biologic-naïve patients with moderate to severely active UC in a 2:1 ratio, GLPG3970 to placebo. One out of 21 patients discontinued in the active treatment arm (COVID-19) versus one out of 10 on placebo (QT abnormality at baseline). 

    At Week 6, positive signals were observed in patients on GLPG3970 on objective parameters such as endoscopy, histology, and fecal calprotectin. These findings did not translate in a differentiation from placebo on change from baseline total Mayo Clinic Score in this 6-week study (GLPG3970 -2.7, placebo -2.6). Seven out of 18 patients on GLPG3970 who underwent endoscopy at Week 6 met the criteria for Endoscopic Improvement, defined as a score of 0 or 1 on the endoscopic response score, compared to one out of 9 patients on placebo. The robustness of these signals will be further examined when additional efficacy and biomarker data become available later this year.

    LADYBUG study: Phase 2a trial in RA

    This study randomized 28 patients with moderate to severely active RA and an inadequate response to methotrexate in a 3:2 ratio, GLPG3970 to placebo. Three out of 16 patients discontinued in the treatment arm (COVID-19, ALT increase and physician decision) versus 2 out of 12 on placebo (COVID-19).

    At Week 6, patients on GLPG3970 showed no differentiation from placebo on change from baseline DAS28 (CRP)2 response (GLPG3970 -1.29, placebo -1.24), nor on the majority of other efficacy endpoints.

    Further development of Toledo product portfolio

    GLPG3970 is the first compound from Galapagos' broad portfolio of novel molecules to provide clinical evidence for the potential role of SIK inhibition in inflammation. Biomarker data from these signal-finding studies with GLPG3970 will be further analyzed for signature profiles. Our aim with the Toledo program is to  explore this novel mode of action fully and bring forward improved molecules directed toward SIK2/3 as well as other SIK selectivity profiles. Galapagos currently has two compounds exhibiting SIK2/3 inhibition in preclinical development.

    "We are excited to demonstrate, for the first time, important biologic and clinical effects with a SIK inhibitor in patients with inflammatory conditions. This is a major achievement when working on a novel mode of action target class. The CALOSOMA trial in psoriasis patients indicates clear proof of activity and the SEA TURTLE trial in ulcerative colitis patients provides encouraging results that support further development with Toledo compounds with improved pharmacology. In addition, these studies in patients confirm the safety and tolerability profile previously observed in healthy volunteers," said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. "The GLPG3970 broad dataset is an important step forward, and we aim to apply key learnings from these studies to the further development of our Toledo portfolio of SIK inhibitors."

    Galapagos intends to submit study outcomes with GLPG3970 for publication at scientific conferences and in peer-reviewed medical journals.

    About Toledo

    "Toledo" is an extensive program with a novel target class, SIK, whose potential role in inflammation was discovered by Galapagos. The Toledo program aims to treat a broad range of autoimmune conditions with important unmet medical needs. The Toledo platform delivers small molecule inhibitors of SIK targets with different selectivity profiles. The most advanced compound, SIK2/3 inhibitor GLPG3970, has shown immunomodulatory activity in vitro preclinically and ex vivo clinically with what Galapagos believes is a dual mode of action characterized by enhanced transcription of anti-inflammatory cytokines and inhibited transcription of pro-inflammatory cytokines. SIK inhibition has previously shown encouraging preclinical activity in a range of inflammatory disease models.

    GLPG3970 is an investigational drug and not approved by any regulatory authority. Its efficacy and safety have not been established.

    About Galapagos

    Galapagos NV ((Euronext &, NASDAQ:GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in clinical development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis, and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at www.glpg.com.

    This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

    Contacts



    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    ir@glpg.com

    Media:

    Kyra Obolensky

    Senior Director Corporate Communications

    +32 491 92 64 35

    Evelyn Fox

    Director Executive Communications

    +31 65 3591 999

    communications@glpg.com

    Galapagos Forward-Looking Statements

    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 differ 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 GLPG3970 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 GLPG3970 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties and that Galapagos' estimations regarding its GLPG3970 development program and regarding the commercial potential of GLPG3970 as well as regarding its Toledo platform, 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 2020 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 management's 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.


    1 Psoriasis Area and Severity Index; an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area

    2 DAS28 is a RA Disease Activity Score based on a calculation that uses tender and swollen joint counts of 28 defined joints, the physician's global health assessment and a serum marker for inflammation, such as C-reactive protein. DAS28 (CRP) includes the C-reactive protein score calculation

     

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  3. New post-hoc analyses of data from SELECTION Phase 3 program presented at European Crohn's and Colitis Organisation (ECCO) virtual congress

    Mechelen, Belgium; 10 July 2021, 11.10 CET; Galapagos NV ((Euronext &amp, NASDAQ:GLPG) today announced new post-hoc analyses from the Phase 3 SELECTION program, supporting the activity and tolerability of filgotinib, a once-daily, oral JAK1 preferential inhibitor, under investigation for the treatment of patients with moderately to severely active ulcerative colitis (UC). These data were presented at the European Crohn's and Colitis Organisation (ECCO) 16th annual congress.

    A post-hoc analysis of the induction study data from SELECTION showed significant improvements in patient-reported outcomes…

    New post-hoc analyses of data from SELECTION Phase 3 program presented at European Crohn's and Colitis Organisation (ECCO) virtual congress

    Mechelen, Belgium; 10 July 2021, 11.10 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced new post-hoc analyses from the Phase 3 SELECTION program, supporting the activity and tolerability of filgotinib, a once-daily, oral JAK1 preferential inhibitor, under investigation for the treatment of patients with moderately to severely active ulcerative colitis (UC). These data were presented at the European Crohn's and Colitis Organisation (ECCO) 16th annual congress.

    A post-hoc analysis of the induction study data from SELECTION showed significant improvements in patient-reported outcomes (PROs) of stool frequency (SF) and of rectal bleeding (RB), that were observed as early as the first week of therapy in patients on 200mg of filgotinib daily versus placebo in patients with moderately to severely active UC. These findings were observed in both biologic-naïve and biologic-experienced patients. More patients receiving filgotinib 200mg versus placebo achieved a composite score of RB=0 and SF≤1 as early as day 9 in Induction study A (biologic-naïve; filgotinib 200mg 18.8%, placebo 9.5%, p<0.05) and as early as day 7 in Induction study B (biologic-experienced; filgotinib 200mg 10.7%; placebo 4.2%, p<0.05).1

    A further post-hoc analysis of the SELECTION maintenance study reported the proportion of patients who were steroid-free at different timepoints, before achieving remission at Week 58. These data indicated that filgotinib 200mg reduced and eliminated corticosteroid (CS) use versus placebo at Week 58 in patients with moderately to severely active UC. Compared with placebo, a significantly higher proportion of patients who demonstrated CS-free remission at Week 58 with filgotinib 200mg had been CS-free in the previous six months (27% filgotinib 200mg vs 6% placebo, 95% CI 21 (8, 34), with a difference seen from as early as the previous eight months (22% filgotinib 200mg vs 6% placebo, 95% CI 15 (3, 28)).2

    Additional safety analysis from SELECTION, combining induction, maintenance and the long-term extension study data, with a cumulative treatment exposure of 1,207 patient years for filgotinib 200mg versus 318 patient years for placebo, showed results consistent with the original induction and maintenance trials, where filgotinib was well tolerated in patients with moderately to severely active UC.3

    Walid Abi-Saab, Chief Medical Officer at Galapagos stated, "Listening to the needs of patients living with moderately and severely active UC, and the healthcare professionals treating them, helps us understand the importance of finding treatments that address both clinical symptoms and patient reported outcomes. These new data from SELECTION and the long-term extension study suggest that patients with moderately to severely active UC have experienced rapid response, sustained steroid-free remission and long-term tolerability when taking filgotinib 200mg versus those on a placebo".

    About Ulcerative Colitis

    Ulcerative colitis (UC) is a chronic type of inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across Europe an estimated 2 million people4 are affected by IBD, which includes UC and Crohn's Disease (CD). It is a chronic inflammatory condition of the gastrointestinal (GI) tract. The disease course of UC is often a state of flare ups and ensuing periods of remission. In addition to the physical impact from flare ups, there is also a significant psychological impact associated with UC, which is further compounded by the perceived stigma of the condition.

    About the SELECTION Phase 3 Trial

    The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.

    Across both induction studies, 1348 patients with moderately to severely active UC were randomized to receive either filgotinib 200mg, filgotinib 100mg or placebo in a 2:2:1 ratio. Moderately to severely active UC was defined as a centrally read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and Physician Global Assessment (PGA) of ≥ 2 based on the Mayo Clinic Score (MCS). 644 patients with clinical remission or response at Week 10 of induction were subsequently re-randomized to the induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58.

    The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with moderately to severely active UC. A majority of patients included in the trials had a MCS of 9 or higher at baseline, and 43% of biologic experienced patients had insufficient response to a TNF antagonist and vedolizumab as well.

    For SELECTION study information visit: https://clinicaltrials.gov/ct2/show/NCT02914522

      

    About filgotinib

    Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the European Union, Great Britain, and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. The Great Britain and Northern Ireland Summary of Product Characteristics is available at www.medicines.org.uk/emc. Applications have been submitted to the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent and are currently under review. Filgotinib is not approved in any other countries.

    About the filgotinib collaboration

    Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos will be responsible for the commercialization of filgotinib in Europe (transition anticipated to be completed by end of 2021), while Gilead will remain responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai. Filgotinib in UC has been filed in Europe, the UK and Japan, and a global Phase 3 program is ongoing in Crohn's Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov

      

    About Galapagos

    Galapagos NV discovers, develops, and commercializes small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biotech company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.

    1. Danese. S, et al. Rapidity of symptom improvements during filgotinib induction therapy in patients with Ulcerative Colitis: post hoc analysis of the phase 2b/3 SELECTION study. OP37, ECCO Congress 2021
    2. Loftus, E, et al. Corticosteroid-free remission of Ulcerative Colitis with filgotinib maintenance therapy: post hoc analysis of the phase 2b/3 SELECTION study DOP82, ECCO Congress 2021
    3. Schreiber. S, et al. Safety analysis of filgotinib for Ulcerative Colitis: results from the phase 2b/3 SELECTION study and phase 3 SELECTIONLTE long-term extension study. OP04, ECCO Congress 2021
    4. Burisch J. et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337

      

    Contacts

    Investors:

    Elizabeth Goodwin

    VP Investor Relations

    +1 781 460 1784

    Sofie Van Gijsel

    Senior Director Investor Relations

    +1 781 296 1143

    ir@glpg.com

    Media:

    Carmen Vroonen

    Global Head of Communications & Public Affairs

    +32 473 824 874

    Anna Gibbins

    Senior Director Therapeutic Areas Communications

    +44 7717 801900

    communications@glpg.com

    Forward Looking Statements

    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 differ 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 inherent risks associated with clinical trial and product development activities, including the SELECTION study, competitive developments, and regulatory approval requirements, including the risk that the results of the SELECTION study may not support continued approval of Jyseleca for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent due to safety, efficacy or other reasons , the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos' reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, Galapagos' estimations regarding its filgotinib development program and regarding the commercial potential of filgotinib, risks related to the implementation of the transition of the European commercialization responsibility to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 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 management's 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. 

     

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