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ARGEN-X 2018 nieuws THE BIG SURPRISER FOR NEXT YEARS 2018 nieuws

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  1. Nice guy 8 juni 2018 12:17
    quote:

    Investor68 schreef op 8 juni 2018 11:51:

    [...]

    I noticed that I misspelled a word in my original statement above; I have to re-write it to make the correction.

    Argen-x is solid and very promising! You must have it in your portfolio especially as we move to the second half of the year.
    ?????
  2. nelis h 8 juni 2018 22:20
    Enthousiasme alom
    ik begrijp het, ik had die koers ook liever in euro's gezien :)
    wellicht dit jaar nog als bevestigd wordt dat de antibodies een goed alternatief zijn voor de CAR-T
    Op die verwachting ook posities in MRUS en MOR
  3. Joho 2.0 12 juni 2018 09:03
    @Tuut: het bericht van de Tuinman slaat op ARG113 dat ook voor P Vulgaris inzetbaar is.
    Ik las echter op het Beursig forum dit bericht van waitingformoney:
    Zie slide 25 van corporate presentation over Rituximab: • "Rituximab therapy shows slow slow onset of action, risk of developing serious adverse events and significant relapse rate (2)(3)(4)" Dit is geen verrassing
    Lees meer op: beursig.com/forum/viewtopic.php?f=4&a...
  4. +brammeke 12 juni 2018 09:19
    argenx to host KOL breakfast symposium on immune thrombocytopenia on June 19, 2018


    12 juni 2018 07:00
    June 12, 2 018
    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 will host a key opinion leader (KOL) breakfast meeting focused on the potential of efgartigimod to treat patients with immune thrombocytopenia (ITP) on Tuesday, June 19, 2018, from 8:30 a.m. to 10:30 a.m. ET in New York City.
    The event will feature guest speaker Catherine Broome, MD, of Georgetown University Hospital, who will highlight the treatment landscape and unmet need in ITP. Additionally, members of our management will present on the market opportunity, biological rationale of efgartigimod in ITP and trial design of the ongoing Phase 2 study.
    A live webcast of the event will be available via this link . The webcast will be archived following the event and available for download on our website at www.argenx.com.
    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.
  5. ReBa 14 juni 2018 07:44
    argenx announces data from Phase 1 study of efgartigimod (ARGX-113) subcutaneous formulation demonstrating comparable characteristics to intravenous formulation

    June 14, 2018

    Subcutaneous formulation offers potential for increased patient convenience and acceptance -
    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 results from its Phase 1 clinical trial evaluating a subcutaneous (SC) formulation of efgartigimod (ARGX-113) in healthy volunteers. The data show that at the same dose level the SC formulation was comparable across key measures, including half-life, pharmacodynamics and tolerability, to the intravenous (IV) formulation used in clinical studies to date.

    argenx intends to use the data from the Phase 1 study to further explore SC dosing schedules of efgartigimod as a more convenient administration option for patients, including the potential of a loading dose of IV efgartigimod followed by SC maintenance.

    “We believe the development of a SC formulation could offer a more tailored therapy by providing flexible dosing options and greater convenience for patients. With a SC formulation, we also plan to explore the potential for an off-the-shelf delivery system using a fine bore needle size to allow patients additional optionality around administration,” said Keith Woods, Chief Operating Officer at argenx. “Based on the data presented today showing that SC dosing can maintain IgG suppression, we intend to further develop this product candidate within our efgartigimod portfolio.”

    The open-label, Phase 1 study enrolled 32 healthy volunteers and included three treatment arms: one each of single dose SC and IV efgartigimod, and one evaluating an IV induction followed by a SC maintenance dose. In the single dose treatment arms, the data showed the SC formulation to have comparable half-life, pharmacodynamics and tolerability to the IV formulation, and a bioavailability of approximately 50%. In addition, initial IV dosing followed by weekly 300 mg (2 ml) SC administration of efgartigimod provided sufficient exposure to maintain IgG suppression at a steady state IgG reduction of approximately 50%. The data also suggest a favorable tolerability profile and no meaningful anti-drug antibody signals were reported. The SC formulation supports key manufacturing improvements, including a high product concentration (150mg/ml), low viscosity and optimal stability.

    About efgartigimod Phase 2 Trials

    Efgartigimod is currently being tested in two Phase 2 clinical trials for immune thrombocytopenia (ITP) and pemphigus vulgaris (PV). argenx is also preparing for a potential Phase 3 clinical trial in myasthenia gravis (MG) using the IV formulation of efgartigimod. In a Phase 2 clinical trial with MG patients, the IV formulation was well-tolerated and showed promising pharmacodynamic effects relating to speed, depth and duration of total IgG and pathogenic IgG reduction.

    About efgartigimod

    Efgartigimod (ARGX-113) is an investigational therapy for IgG-mediated autoimmune diseases and was designed to exploit the natural interaction between IgG antibodies and the recycling receptor FcRn. Efgartigimod is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG™ technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, efgartigimod blocks antibody recycling through FcRn binding and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on efgartigimod is conducted 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))
  6. +brammeke 14 juni 2018 07:44
    argenx announces data from Phase 1 study of efgartigimod (ARGX-113) subcutaneous formulation demonstrating comparable characteristics to intravenous formulation


    14 juni 2018 07:00
    - Subcutaneous formulation offers potential for increased patient convenience and acceptance -
    June 14, 2018
    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 results from its Phase 1 clinical trial evaluating a subcutaneous (SC) formulation of efgartigimod (ARGX-113) in healthy volunteers. The data show that at the same dose level the SC formulation was comparable across key measures, including half-life, pharmacodynamics and tolerability, to the intravenous (IV) formulation used in clinical studies to date.
    argenx intends to use the data from the Phase 1 study to further explore SC dosing schedules of efgartigimod as a more convenient administration option for patients, including the potential of a loading dose of IV efgartigimod followed by SC maintenance.
    "We believe the development of a SC formulation could offer a more tailored therapy by providing flexible dosing options and greater convenience for patients. With a SC formulation, we also plan to explore the potential for an off-the-shelf delivery system using a fine bore needle size to allow patients additional optionality around administration," said Keith Woods, Chief Operating Officer at argenx. "Based on the data presented today showing that SC dosing can maintain IgG suppression, we intend to further develop this product candidate within our efgartigimod portfolio."
    The open-label, Phase 1 study enrolled 32 healthy volunteers and included three treatment arms: one each of single dose SC and IV efgartigimod, and one evaluating an IV induction followed by a SC maintenance dose. In the single dose treatment arms, the data showed the SC formulation to have comparable half-life, pharmacodynamics and tolerability to the IV formulation, and a bioavailability of approximately 50%. In addition, initial IV dosing followed by weekly 300 mg (2 ml) SC administration of efgartigimod provided sufficient exposure to maintain IgG suppression at a steady state IgG reduction of approximately 50%. The data also suggest a favorable tolerability profile and no meaningful anti-drug antibody signals were reported. The SC formulation supports key manufacturing improvements, including a high product concentration (150mg/ml), low viscosity and optimal stability.
    About efgartigimod Phase 2 Trials
    Efgartigimod is currently being tested in two Phase 2 clinical trials for immune thrombocytopenia (ITP) and pemphigus vulgaris (PV). argenx is also preparing for a potential Phase 3 clinical trial in myasthenia gravis (MG) using the IV formulation of efgartigimod. In a Phase 2 clinical trial with MG patients, the IV formulation was well-tolerated and showed promising pharmacodynamic effects relating to speed, depth and duration of total IgG and pathogenic IgG reduction.

    About efgartigimod
    Efgartigimod (ARGX-113) is an investigational therapy for IgG-mediated autoimmune diseases and was designed to exploit the natural interaction between IgG antibodies and the recycling receptor FcRn. Efgartigimod 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, efgartigimod blocks antibody recycling through FcRn binding and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies. The development work on efgartigimod is conducted 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 auto-immune diseases and cancer. The company is 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. argenx' ability to execute on this focus is enabled by its suite of differentiated technologies. The SIMPLE Antibody TM Platform, based on the powerful llama immune system, allows argenx to exploit novel and complex targets, and the three antibody engineering technologies are designed to enable the expansion of the therapeutic index of the company's product candidates.
  7. +brammeke 14 juni 2018 07:56
    Subcutane injectie middel Argen-x even effectief als intraveneuze

    14 jun 2018 om 07:27
    (ABM FN) Een subcutane injectie bij auto-immuniteitsmiddel efgartigimod van Argen-x zou even effectief zijn als een intraveneuze injectie. Dit liet biotechbedrijf Argen-x donderdag voorbeurs weten naar aanleiding van Fase I onderzoeken.

    De testen voor het middel met een intraveneuze injectie zitten al in een verder stadium. De eerste testen voor een minder diepe subcutane injectie wijzen echter op een even vergelijkbare effectiviteit en tolerantie.

    Het bedrijf wijst erop dat deze behandeling voor een hogere acceptatie en groter gemak zal zorgen bij patiënten.

    Het aandeel van Argen-x sloot woensdag 0,5 procent lager op 84,50 euro.
  8. forum rang 4 Jan66 14 juni 2018 12:22
    quote:

    BrightSight schreef op 14 juni 2018 10:30:

    Gebeurt geen reet!
    Even wachten hoe de Amerikanen dit nieuws oppakken .
  9. forum rang 6 de tuinman 14 juni 2018 16:04
    quote:

    BrightSight schreef op 14 juni 2018 15:34:

    En weer zakken we ineens dik weg... wat raar zeg !
    Ik begrijp dat je een stijging verwacht en ik denk dat je net in dit aandeel zit.
    Maar vergeet niet dat we net al een extreme stijging achter de rug hebben. Een correctie is dan vrij logisch.

    Maar niks is zeker natuurlijk...
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