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Genmab, de Deense parel

3.291 Posts
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  1. Highlands 20 juni 2022 21:31
    Genmab A/S
    Major Shareholder Announcement
    Company Announcement

    Major shareholder announcement for Genmab A/S

    COPENHAGEN, Denmark; June 20, 2022 – Genmab A/S (Nasdaq: GMAB) announces under reference to Section 30 of the Danish Capital Markets Act that Wellington Management Group LLP has informed us that, as of June 15, 2022 Wellington Management Group LLP had decreased their holding of shares in Genmab A/S to 4.99% of the share capital and voting rights in Genmab A/S, so that through shares and financial instruments they held the voting rights to 3,293,871 shares in Genmab A/S, which amounts to 5.00% of the share capital and voting rights in Genmab A/S.

    Subsequently, Wellington Management Group LLP informed us that, as of June 16, 2022 Wellington Management Group LLP had increased their holding of shares in Genmab A/S to 5.00% of the share capital and voting rights in Genmab A/S, so that through shares and financial instruments they held the voting rights to 3,298,282 shares in Genmab A/S, which amounts to 5.01% of the share capital and voting rights in Genmab A/S.

    Wat is hier nu precies gebeurd?
  2. Pokerface 1 juli 2022 15:43
    Genmab to Submit Biologics License Application to U.S. Food and Drug Administration for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
    Company Announcement

    COPENHAGEN, Denmark; June 30, 2022 – Genmab A/S (Nasdaq: GMAB) today announced its intent to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022.

    The BLA submission is supported by results from the large b-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). In April 2022, Genmab and AbbVie announced the topline results from EPCORE™ NHL-1 trial. In June 2022, primary results were presented in a late-breaking oral presentation as part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022) in Vienna, Austria.

    “Relapsed or refractory large B-cell lymphoma is often difficult to treat, and patients are in need of novel therapies that are effective, tolerable and accessible,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The results from the EPCORE NHL-1 trial, and other clinical trials evaluating epcoritamab in a variety of patients and treatment settings, have demonstrated that epcoritamab has the potential to offer people living with LBCL a new therapeutic advance with a manageable safety profile.”

    Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies are committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL (NCT: 04628494).

    About Large B-cell Lymphoma (LBCL)
    LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. LBCL includes DLBCL, which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.i,ii,iii,iv

    About the EPCORE™ NHL-1 Trial
    EPCORE™ NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a phase 1 first-in-human, dose escalation part; a phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. Data from the dose escalation part of the study, which determined the recommended phase 2 dose, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

    The primary endpoint of the phase 2 expansion part was overall response rate (ORR) as assessed by an IRC. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

    About Epcoritamab
    Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.v CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.vi,vii

    About Genmab
    Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
  3. sheriff Grover 8 juli 2022 09:20
    OT.

    Hoi Irenesebregts ,

    Dat was idd een hele mooie stijging van BOLT en geen idee waarom , ik heb niks kunnen vinden .
    Vandaag afwachten of hij de stijging vasthoud en weer niet al te ver terug zakt . Het aandeel is natuurlijk zo verschrikkelijk afgestraft dat het maar een klein beetje positiviteit nodig heeft om een stuk van die afstraffing terug te winnen . ... Ik denk dat als ze ook maar iets kunnen laten zien het aandeel zo richting de $6 -$8 kan. (ze hebben al $4.65 p.a. in kas) .
    Ik houd me ook maar een beetje vast aan JvdW die zal toch niet helemaal voor niets € 18.27 per aandeel hebben betaald ?? ;o) gr SG
  4. forum rang 10 DeZwarteRidder 11 augustus 2022 18:52
    Genmab Announces Financial Results for the First Half of 2022
    Genmab A/S Tel: +45 7020 2728 Company Announcement no. 41
    Kalvebod Brygge 43 Fax: +45 7020 2729 Page 1/35
    1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
    August 10, 2022 Copenhagen, Denmark;
    Interim Report for the First Six Months Ended June 30, 2022
    Highlights
    • Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab from the
    Phase 1/2 trial in patients with relapsed/refractory large B-cell lymphoma (LBCL)
    • Genmab announced its intent to submit a biologics license application (BLA) to the U.S.
    Food and Drug Administration (U.S. FDA) for epcoritamab for the treatment of patients
    with relapsed/refractory LBCL, in the second half of 2022
    • DARZALEX® net sales as reported by Johnson & Johnson increased 37% compared to the
    first six months of 2021 to USD 3,842 million, resulting in royalty revenue to Genmab of
    DKK 4,024 million
    • Genmab announced the resolution of its arbitration with Janssen Biotech, Inc. (Janssen)
    under its daratumumab license agreement and subsequently commenced a new
    arbitration under the daratumumab license agreement with Janssen
    • Genmab improves its 2022 financial guidance
    “Genmab’s innovation was on display during the second quarter of 2022 with data presentations at
    multiple prestigious conferences and the publication by Genmab, and our partner, AbbVie, of topline
    results for epcoritamab from the Phase 1/2 trial in patients with relapsed/refractory LBCL. Based on this
    data, we intend to submit a BLA to the U.S. FDA for epcoritamab in the second half of this year,” said Jan
    van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    Financial Performance First Half of 2022
    • Net sales of DARZALEX by Janssen were USD 3,842 million in the first six months of 2022
    compared to USD 2,798 million in the first six months of 2021, an increase of USD 1,044 million,
    or 37%.
    • Royalty revenue was DKK 4,727 million in the first six months of 2022 compared to DKK 2,595
    million in the first six months of 2021, an increase of DKK 2,132 million, or 82%. The increase in
    royalties was driven by higher net sales of DARZALEX, TEPEZZA ® and Kesimpta® and higher
    average exchange rate between the USD and DKK.
    • Revenue was DKK 5,281 million for the first six months of 2022 compared to DKK 3,553 million
    for the first six months of 2021. The increase of DKK 1,728 million, or 49%, was primarily driven
    by higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations with
    Janssen, Roche and Novartis Pharma AG (Novartis), respectively, partly offset by milestones
    achieved under our collaborations with Janssen and AbbVie in the first six months of 2021.
    • Operating expenses were DKK 3,520 million in the first six months of 2022 compared to DKK
    2,234 million in the first six months of 2021. The increase of DKK 1,286 million, or 58%, was
    driven by the continued advancement of epcoritamab and multiple pipeline projects, an increase
    in new employees to support Tivdak ® post launch and expansion of our product pipeline, and the
    continued development of Genmab’s commercialization and broader organizational capabilities
    and infrastructure.
    • Operating profit was DKK 1,761 million in the first six months of 2022 compared to DKK 1,319
3.291 Posts
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