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Aandeel arGEN-X BRU:ARGX.BL, NL0010832176

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arGEN-X Nieuws 2017

568 Posts
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  1. [verwijderd] 7 juli 2017 09:40
    Mooi nieuws .

    July 7, 2017

    Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that its abstract covering the complete data set from its Phase Ib study of ARGX-111 in patients with advanced cancers over-expressing the MET protein was selected as part of the Best of ASCO program at the 3rd Singapore Society of Oncology Annual Scientific Meeting in Singapore.

    "The differentiated design of ARGX-111 to enhance killing of advanced tumor cells offers a really exciting approach to treating patients with MET-driven cancers," commented Nicolas Leupin, Chief Medical Officer of argenx. "We are pleased to see preliminary anti-tumor activity and a consistently favorable safety profile, which was the goal of this expansion study. These data offer a compelling path forward to further examine in a Phase 2 study the activity of ARGX-111, which we are looking to strategically partner."

    The new data from the Phase Ib study continue to show evidence of anti-tumor activity with ARGX-111 at all dose levels and across different indications. Partial response and stable disease were observed, respectively, in one and nine of 24 heavily pretreated patients with MET-positive malignancies, both MET-gene-amplified and with MET overexpression. Treatment-emerging adverse events were reported for all patients, but none of the grade 5 toxicities were related to ARGX-111. The poster presented at Best of ASCO can be accessed from the "Downloads" section of the argenx website.

    About ARGX-111

    ARGX-111 was developed for the treatment of patients with certain solid tumors that overexpress c-Met, a receptor associated with tumor growth and metastasis, or tumors that are mesenchymal-epithelial transition factor, or MET, amplified. ARGX-111 employs the SIMPLE AntibodyTM, NHance® and POTELLIGENT® technologies to drive tissue penetration in the body and to increase its ability to enhance ADCC. ARGX-111 binds to c-Met with high affinity and does not cause dimerization of the c-Met receptor, which differentiates it from other, earlier attempts to direct antibodies against c-Met. Dimerization is a process which can result in receptor activation, undermining the intended therapeutic effect of antibodies blocking hepatocyte growth factor, or HGF, binding to c-Met. By blocking both HGF-dependent and independent c-Met activation, ARGX-111 is able to block c-Met receptor activation which could trigger survival, proliferation and metastasis of tumor cells. In order to further examine the activity of the product candidate in a Phase 2 study, argenx is actively looking for an appropriate collaboration partner.



  2. [verwijderd] 7 juli 2017 15:36
    argenx SE – American Depositary Shares (NASDAQ:ARGX) Research Coverage Started at JMP Securities
    July 6th, 2017 - By Doug Wharley - 0 comments


    argenx SE - American Depositary Shares logoJMP Securities initiated coverage on shares of argenx SE – American Depositary Shares (NASDAQ:ARGX) in a report released on Monday, June 12th, MarketBeat.com reports. The brokerage issued an outperform rating and a $33.00 price objective on the stock.

    Separately, Cowen and Company began coverage on argenx SE – American Depositary Shares in a research report on Monday, June 12th. They set an outperform rating on the stock.

    argenx SE – American Depositary Shares (NASDAQ:ARGX) traded up 0.44% during midday trading on Monday, reaching $20.40. 59,300 shares of the company’s stock traded hands. argenx SE – American Depositary Shares has a one year low of $17.33 and a one year high of $25.00. The stock’s market cap is $548.17 million. The stock’s 50 day moving average price is $20.80 and its 200-day moving average price is $20.80.
  3. [verwijderd] 25 juli 2017 09:20
    Zit er een nieuwe partner aan te komen ?
    Gisteren in de USA zo maar 21,42 slot = 18,39 euro

    About ARGX-111

    ARGX-111 was developed for the treatment of patients with certain solid tumors that overexpress c-Met, a receptor associated with tumor growth and metastasis, or tumors that are mesenchymal-epithelial transition factor, or MET, amplified. ARGX-111 employs the SIMPLE AntibodyTM, NHance® and POTELLIGENT® technologies to drive tissue penetration in the body and to increase its ability to enhance ADCC. ARGX-111 binds to c-Met with high affinity and does not cause dimerization of the c-Met receptor, which differentiates it from other, earlier attempts to direct antibodies against c-Met. Dimerization is a process which can result in receptor activation, undermining the intended therapeutic effect of antibodies blocking hepatocyte growth factor, or HGF, binding to c-Met. By blocking both HGF-dependent and independent c-Met activation, ARGX-111 is able to block c-Met receptor activation which could trigger survival, proliferation and metastasis of tumor cells. In order to further examine the activity of the product candidate in a Phase 2 study, argenx is actively looking for an appropriate collaboration partner.

    ,, In order to further examine the activity of the product candidate in a Phase 2 study, argenx is actively looking for an appropriate collaboration partner. ,,
  4. [verwijderd] 8 augustus 2017 09:12
    argenx to present at Wedbush PacGrow Healthcare Conference

    August 08, 2017

    Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that Chief Executive Officer, Tim Van Hauwermeiren, will present a corporate update at the Wedbush PacGrow Healthcare Conference in New York on Tuesday, August 15, 2017 at 1:20 p.m. EDT.

    The presentation will be webcast live and may be accessed on the argenx website at www.argenx.com or by clicking here. A replay of the webcast will be available for 90 days following the presentation.



    About argenx

    argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody™ Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.

    www.argenx.com



    For further information, please contact:

    Joke Comijn, Corporate Communications Manager

    +32 (0)477 77 29 44

    +32 (0)9 310 34 19

    info@argenx.com
  5. [verwijderd] 24 augustus 2017 09:07
    Mooie ontwikkelingen

    Published: 07:00 CEST 24-08-2017 /GlobeNewswire /Source: argenx SE / : ARGX /ISIN: NL0010832176

    argenx reports second quarter business update and half-year 2017 financial results

    Management to host conference call today at 3 p.m. CEST / 9 a.m. EDT



    August 24, 2017

    Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced its second quarter business update and half-year financial results for 2017.



    The half-year results will be discussed during a conference call and webcast presentation today at 3 p.m. CEST/ 9 a.m. EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 3427020. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

    "The first half of 2017 has been a period of momentous growth for argenx. We completed our U.S. public offering on Nasdaq, which not only broadened our U.S. shareholder base, but also provided us with additional capital to push forward the development of our two lead drug candidates ARGX-113 and ARGX-110. ARGX-113 is progressing in both MG and ITP studies. ARGX-110 is continuing to show encouraging signs of biological activity and a promising safety profile in CTCL patients and is being tested in a combination trial in newly diagnosed AML patients. We expect to have top-line data from the Phase 2 studies in 2018," commented Tim Van Hauwermeiren, CEO of argenx. "We also furthered our commitment to our antibody pipeline, which we continue to grow through our strategic collaborations. We announced two new partnerships this year with Staten Biotech and Broteio in very exciting therapeutic areas and made progress with our ongoing collaborations with AbbVie and Leo resulting in two milestone payments in the second quarter. Through both our wholly-owned and partnered programs, we are driving our mission forward to develop differentiated antibody candidates for patients in need."



    SECOND QUARTER 2017 AND RECENT BUSINESS HIGHLIGHTS

    Products in clinical development:

    ARGX-113

    Reached 50% enrollment in Phase 2 clinical trial of ARGX-113 in myasthenia gravis (MG). The double-blind, placebo-controlled Phase 2 study is enrolling up to 24 MG patients with confirmed generalized muscle weakness.


    ARGX-110

    Launched Phase 2 study of ARGX-110 as a monotherapy in relapsed/refractory cutaneous T-cell lymphoma (CTCL) patients. The goal of the study is to further evaluate the intrinsic activity of the drug in CTCL patients and to broaden the safety and efficacy database.
    Presented updated data from Phase 1b expansion study of ARGX-110 in patients with CTCL at the International Conference of Malignant Lymphoma (ICML). Data continue to show evidence of clinical and/or biological anti-tumor activity across different CTCL subtypes and different disease stages.


    ARGX-111

    Met safety endpoints in the Phase 1 clinical trial. Complete data set presented from ARGX-111 Phase 1b study in patients with advanced cancers over-expressing the MET protein at Best of ASCO Asia 2017 (Singapore).

    Collaborations:

    Received first of two preclinical milestone payments from AbbVie under our collaboration for ARGX-115, triggering a $10 million payment from AbbVie.
    Received second preclinical milestone payments in collaboration with LEO Pharma for ARGX-112. argenx is responsible for conducting ARGX-112 research and development activities up to a first filing by LEO Pharma for clinical trial application (CTA) approval.
    Announced publication of new preclinical data in 'Nature Medicine' on ARGX-116 inhibiting ApoC3, a metabolic target correlated with blood lipid levels, that provide further rationale for the therapeutic potential of ARGX-116 for the treatment of dyslipidemia.

    Corporate:

    Continued execution of intellectual property strategy with multiple grants and notices of allowance for SIMPLE AntibodyTM platform (U.S. and EU), ARGX-110 (U.S., EU, and Japan) and ARGX-111 (Japan and EU). argenx now has 128 patents granted and 68 pending patent applications.
    Increased headcount to 67 persons in support of the expansion of the business.


    FINANCIAL HIGHLIGHTS (as of June 30, 2017) (compared to financial highlights as of June 30, 2016)

    Raised approximately €102 million ($115 million) of gross proceeds (before underwriter discounts and commissions and offering expenses) with Nasdaq initial public offering (IPO) in the United States of 6,744,750 American Depositary Shares (ADSs), at a price to the public of $17.00 per ADS. This includes the full exercise of the underwriters' option to purchase additional ADSs.
    Operating income of €23.9 million (June 30, 2016: €7.0 million).
    Total comprehensive loss of €8.2 million (June 30, 2016: €7.4 million).
    Cash position of €173.4 million (cash, cash-equivalents and current financial assets) allowing argenx to pursue development of its pipeline as planned.






    UPCOMING MILESTONES

    ARGX-113

    Topline data from Phase 2 study in MG expected in 1Q 2018 and topline data from Phase 2 study in ITP expected in 2H 2018.
    Initiation of Phase 1 clinical trial of subcutaneous dosing in healthy volunteers expected in 2H 2017.


    ARGX-110

    Interim data from Phase 1/2 study in AML and Phase 2 study in CTCL each expected by the end of 2017 (workshop in conjunction with the ASH Annual Meeting), and topline data from Phase 2 study in CTCL expected by the end of 2018.

    argen-x.com/en-GB/news-internal/argen...
  6. [verwijderd] 20 september 2017 08:48
    Onopvallend en onder de radar dendert Argen-X door . Fly heeft al meermaals gezegd dat er veels te weinig aandacht voor is . Nu zie ik hem zelfs niet meer !?
    Ik zit er al in vanaf de 10 euro( dankzij Fly en onderzoek) en blijf hier LT ( net als Ablynx ) inzitten . Tenzij er iets negatiefs zou opduiken uiteraard . Voorlopig gaat dit bedrijf een steeds grotere opmars maken . Nog niet ontdekt door de grote kudde . Dit gaat nog wel gebeuren .

    argen-x.com/en-GB/content/argenx-in-s...

    Published: 07:00 CEST 20-09-2017 /GlobeNewswire /Source: argenx SE / : ARGX /ISIN: NL0010832176

    argenx reaches 50% enrollment in Phase 2 clinical trial of ARGX-113 in immune thrombocytopenia



    Top-line data from the study expected in second half of 2018 -


    September 20, 2017



    Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it has recruited 50% of the immune thrombocytopenia (ITP) patients in the Phase 2 proof-of-concept study of ARGX-113.



    "We are pleased to have reached the 50% recruitment milestone in this study, which is enrolling on schedule," commented Nicolas Leupin, Chief Medical Officer of argenx. "We remain on track, and look forward to presenting top-line data from the ARGX-113 clinical trial in ITP in the second half of 2018, which will be our second indication with Phase 2 top-line data from ARGX-113."



    The double-blind, placebo controlled Phase II study will enroll up to 36 ITP patients with platelet levels lower than 30 million per milliliter. ARGX-113 will be dosed on top of current standard of care, including corticosteroids and/or immunomodulatory agents and/or TPO-R agonists. The primary endpoints of the trial are safety and tolerability, and secondary endpoints are effect on platelet count and use of rescue treatment, and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.



    The ITP clinical trial was initiated in March 2017. ARGX-113 is also being studied in a Phase 2 proof-of-concept study for the treatment of myasthenia gravis (MG), which was initiated in January 2017.



    About ARGX-113

    ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).



    About argenx

    argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.

    www.argenx.com







    For further information, please contact:



    Joke Comijn, Corporate Communications Manager

    +32 (0)477 77 29 44

    +32 (0)9 310 34 19

    info@arGEN-X.com



    Beth DelGiacco (US IR)

    Stern Investor Relations

    +1 212 362 1200

    beth@sternir.com

  7. [verwijderd] 25 september 2017 12:52
    ZEER GOED NIEUWS

    argenx announces orphan drug designation for ARGX-113 for the treatment of myasthenia gravis

    Non-regulated information





    September 25, 2017



    Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan status for the use of ARGX-113 for the treatment of myasthenia gravis.



    MG is an autoimmune disorder associated with muscle weakness that is triggered by IgG auto-antibodies. These antibodies attack critical signalling proteins at the junction between nerve and muscle cells, thereby impairing their communications signals. There are limited effective and sustainable treatments for MG. ARGX-113 has the potential to eliminate patient symptoms while minimizing common side effects seen with current treatments by reducing the pathogenic IgG levels.



    About orphan drug designation

    Orphan drug status is granted by FDA to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan drug designation qualifies for various development incentives, including tax credits for qualified clinical testing, a waiver from FDA's application User Free for marketing application, and a 7-year period of marketing exclusivity in the US.

    The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.



    About ARGX-113

    ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).

  8. Pokerface 25 september 2017 23:06
    Inderdaad mooi nieuws, maar extreem weinig reactie in de koers. Wel een veel grotere handel vandaag.
    Voor Galapagos heb ik voor ieder medicijn een apart topic geopend met daarin alle info die beschikbaar is. Omdat het hier nog vrij rustig is, kan ik die info wel in dit topic plakken denk ik. Hieronder alles wat ik zo snel even kon vinden. Vul gerust aan of verbeter waar nodig:

    Medicijn: ARGX-109 (Gerilimzumab)
    Ziekte: Rheumatoid Arthritis (RA)
    Huidige onderzoeksfase: Fase 1 afgerond? Resultaten al bekend?
    Opmerking: Partnered met Bird Rock?

    Medicijn: ARGX-110 (Cusatuzumab)
    Ziekte 1: Cutaneous T-Cell Lymphoma (CTCL)
    Ziekte 2: Acute Myeloid Leukemia
    Huidige onderzoeksfase: Fase 2 onderzoek in T-Cell Lymphoma met verwachte resultaten in H2 2018. Interim update verwacht tegen het einde van 2017 voor CTCL, en voor fase 1 dose-escalation in AML en MDS (welke indicatie is dit?)

    Medicijn: ARGX-111
    Ziekte: Solid Tumors / Blood Cancer
    Huidige onderzoeksfase: Met safety endpoints in the Phase 1 clinical trial. Complete data set presented from ARGX-111 Phase 1b study in patients with advanced cancers over-expressing the MET protein at Best of ASCO Asia 2017 (Singapore).
    Opmerking: Op zoek naar een partner om fase 2 mee te doen.

    Medicijn: ARGX-112
    Ziekte: Skin inflammation
    Huidige onderzoeksfase: Preklinisch?
    Opmerking: Partnered met LEO?

    Medicijn: ARGX-113 (Efgartigimod)
    Ziekte 1: Myasthenia Gravis (MG)*
    Ziekte 2: Immune Thrombocytopenia (ITP)
    Ziekte 3: Chronic Autoimmune Diseases
    Huidige onderzoeksfase: Fase 2 onderzoek in MG en ITP met verwachte resultaten in H2 2018. Start van fase 1 in CAD in H2 2017
    Opmerking: Weesgeneesmiddelstatus sinds 25 september 2017 voor MG

    * MG is an autoimmune disorder associated with muscle weakness that is triggered by IgG auto-antibodies. These antibodies attack critical signalling proteins at the junction between nerve and muscle cells, thereby impairing their communications signals. There are limited effective and sustainable treatments for MG. ARGX-113 has the potential to eliminate patient symptoms while minimizing common side effects seen with current treatments by reducing the pathogenic IgG levels.

    Medicijn: ARGX-115
    Ziekte: Cancer Immunotherapy
    Huidige onderzoeksfase: Preklinisch
    Opmerking: Partnered met AbbVie sinds 20 april 2016

    Medicijn: ARGX-116
    Ziekte: Dyslipidemia
    Huidige onderzoeksfase: Preklinisch
    Opmerking: Partnered met Staten Biotechnology
  9. [verwijderd] 26 september 2017 08:50
    En wederom een mooi nieuw bericht . En velen zitten op de biotechaandelen met een kleine pipeline en vergeten de snel expanderende Argen-X

    Published: 07:00 CEST 26-09-2017 /GlobeNewswire /Source: argenx SE / : ARGX /ISIN: NL0010832176

    argenx launches Phase II proof-of-concept clinical trial of ARGX-113 for the treatment of pemphigus vulgaris



    Interim data expected in H2 2018


    September 26, 2017



    Breda, the Netherlands / Ghent, Belgium - argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the initiation of a Phase II proof-of-concept clinical trial of ARGX-113 in pemphigus vulgaris (PV) patients.



    "PV is a chronic, severe and potentially life-threatening orphan auto-immune disease of the skin for which limited treatment options exist. Disease severity is directly correlated to pathogenic antibodies of the immunoglobulin G (IgG) type targeting desmoglein-1 and -3 in the skin, leading to painful blister formation and skin damage," commented Nicolas Leupin, Chief Medical Officer of argenx. "Current treatment options are limited to high-dose steroids and chronic immunosuppression. We are thrilled about the therapeutic potential of ARGX-113 in PV, based on its mode of action of clearing IgGs. PV represents a clean and rapid proof-of-concept indication and, we believe, is therefore our ideal beachhead into the field of severe auto-immune blistering diseases of the skin."



    The open-label, non-controlled Phase II clinical trial will enroll up to 12 patients with mild to moderate PV who are either newly diagnosed or relapsing. The primary endpoints of the trial are safety and tolerability, and secondary endpoints include efficacy and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers. The study design will be presented in more detail during a PV Key Opinion Leader event which will take place in New York on November 10, 2017.



    ARGX-113 is currently being tested in two additional Phase II clinical trials in myasthenia gravis (MG) and immune thrombocytopenia (ITP). Topline date for MG and ITP are expected in the first quarter and second half of 2018, respectively. In a Phase I clinical trial, ARGX-113 was well-tolerated across multiple doses and dosing regimens with promising pharmacodynamic effects relating to speed, depth and duration of IgG reduction.



    About ARGX-113

    ARGX-113 is an investigational therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).





    About argenx

    argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.

    www.argenx.com

    For further information, please contact:

    Joke Comijn, Corporate Communications Manager

    +32 (0)477 77 29 44

    +32 (0)9 310 34 19

    info@argenx.com

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