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Home  /  Forum  /  BioPharma  /  Genmab, de Deense parel

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Genmab, de Deense parel

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3.499 Posts
Pagina: «« 1 ... 170 171 172 173 174 175 | Laatste | Omlaag ↓
  2. Biotech1982 25 mei 2024 17:53
    Hoi Catch22,
    Ik begin het eerlijk gezegd ook beu te worden, de afgelopen 4 jaar is Genmab meerdere keren onder de 2000DKK gedoken.
    Ze zijn gigantisch aan het uitbreiden, nemen een bedrijf over met een groot deel van de cash ~40% en zijn nog steeds aan het uitbreiden wat de operationele kosten alleen maar meer zal opdrijven.

    Ik weet ook niet hoeveel geduld we nog moeten hebben maar het feit is dat het aandeel giganisch achterblijft op veel andere aandelen.

    Het is wachten op mooie resultaten van
    Epcoritamab: Co-ontwikkeld met AbbVie, dit medicijn richt zich op CD3 en CD20 voor de behandeling van B-cel maligniteiten. De inkomsten en kosten worden 50:50 gedeeld tussen Genmab en AbbVie.

    Tisotumab Vedotin: Ontwikkeld in samenwerking met Seagen, deze antilichaam-geneesmiddel conjugaat richt zich op weefselfactor in solide tumoren. De winst en kosten worden gelijk verdeeld.

    DuoBody-PD-L1x4-1BB (GEN1046) en DuoBody-CD40x4-1BB (GEN1042): Deze zijn onderdeel van een samenwerking met BioNTech, gericht op verschillende solide tumoren. De winst en kosten worden gelijk verdeeld.

    GEN3014 (HexaBody-CD38): Gelicentieerd aan Janssen Biotech, die de ontwikkeling en commercialisatie verzorgt. Genmab ontvangt mijlpaalbetalingen en royalties van Janssen.

    Ik blijf nog wel zitten gezien ik nog steeds hoge verwachtingen heb. Echter ga ik de operationele kosten goed in te gate houden. De royalties van Dara gaan rond 2030 stoppen, dan moet Genmab andere inkomsten bronnen hebben.

    Inmiddels heeft Genmab (2015-2023) voor ~5.8 miljard USD aan royalties van J&J gekregen en dit bedrag loopt nog stevig op, alleen dit jaar waarschijnlijk al rond de 1.9 miljard USD, het is dus de komende jaren echt nog een goudmijn maar dit wordt allemaal teruggepompt in het Genmab vehikel op het inkopen van wat aandelen na dan.

    De operationele kosten in 2023 waren ~1.6 miljard USD en zullen dit jaar al boven de 1.9 miljard USD uitkomen en dat zijn dan de inkomsten over Dara.

    Ik zou liever hebben gezien dat ze veel meer aandelen waren gaan terugkopen en de OpEx kosten wat gingen temperen.

  3. sheriff Grover 25 mei 2024 21:28
    Hi Biotech 1982 , Dank voor je duidelijke overzicht en waarschijnlijk ten overvloede het geduld van mij raakt ook aardig op .... om niet te zeggen dat ik er doodmoe van word ;o)

    Kleine voetnoot betreffende Hexabody cd 38 ; zover ik het heb begrepen zijn alle kosten vooralsnog voor Genmab , pas na de eventuele opt -in gaat JnJ mee betalen aan de ontwikkeling etc. Ik geloof dat er iets van rond de $325 miljoen aan milestones aan vast zit na een positief besluit .
    Maar wat ik al zei daar ben ik niet zo bang voor die opt-in dat zie ik echt wel gebeuren , maar wat dan ?? Weer minimaal tot 2027 wachten tot dat er een product op de markt is en onderwijl weer jaren schommelen tussen de DKR 3000 & DKR 1800 ??

    Ik kan het niet meer opbrengen. Het mooiste scenario en tevens oudste ;o)) is dat ze de opt-in overslaan en eindelijk eens een bod gaan doen op Genmab ... zijn ze helemaal alleen de baas en meteen verlost van die alsmaar oplopende royalties !
  6. catch22 1 juni 2024 20:00
    Voor wat het waard is. GENMAB mailt een positieve ontwikkeling samen met biontech over een fase 2 onderzoek inzake immuun tech. Product longkanker. Zie site. ! Mail
    GENMAB bericht over een positief fase 2 onderzoek samen met Biontech inzake een imuuncombinatie voor longkanker. Zie genmab mail / site.
    Kan impact niet beoordelen .bericht uitgegaan op 1 juni
  7. Sleutel1 1 juni 2024 21:33
    Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)
    Media Release

    COPENHAGEN, Denmark, and MAINZ, Germany; June 1, 2024

    Initial data from the ongoing Phase 2 trial showed a 12-month overall survival (OS) rate of 69% and median overall survival (mOS) of 17.5 months in patients with previously treated PD-L1-positive mNSCLC treated with combination of acasunlimab with pembrolizumab every six weeks
    Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024
    Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) today announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PDL(1)-positive mNSCLC who had disease progression following one or more prior lines of anti-PD(L)1 containing treatment. The results showed a 12-month overall survival (OS) rate of 69%, a median overall survival (mOS) of 17.5 months, and a 30% overall response rate (ORR); (confirmed ORR 17%) at time of data cut-off in patients treated with the combination of acasunlimab and pembrolizumab every six weeks. The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 4, 2024.
  8. Sleutel1 3 juni 2024 13:49
    From Nordea's morning commentary: Genmab (team) - Over the weekend, at the ASCO24 conference in Chicago, Genmab and BioNTech presented updated phase II data for acasunlimab (GEN1046), a PD-L1x4-1BB bispecific antibody in patients with mNSCLC (metastatic non-small cell lung cancer). Novod participated in the poster session and had extensive discussions of the data with researchers behind the study. We are talking very solid overall survival data for acasunlimab (GEN1046) with 17.5 months median OS for acasun+pembro (Keytruda,
  14. Pokerface 27 juni 2024 11:42
    PB:

    EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)
    Company Announcement

    Approval based on results from Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL
    EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need
    EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy

    COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s).

    FL is the second most common form of non-Hodgkin’s lymphoma (NHL), accounting for 20-30 percent of all NHL cases.i About 15,000 people develop FL each year in the U.S.ii FL is considered incurable with current standard of care therapies and patients often relapse.iii,iv With each subsequent line of therapy, patients receiving currently available treatments may experience shorter durability of response.v

    “Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, especially in third-line settings where there is currently no clear standard of care treatment,” said Jeff Sharman, MD, Disease Chair, Hematology Research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon. “This approval and the durable responses observed in the follicular lymphoma cohort of the EPCORE NHL-1 clinical trial, which reflected a real-world patient population, including patients with difficult-to-treat follicular lymphoma, demonstrate the potential of EPKINLY for patients who face limited therapeutic options post-relapse.”

    The approval is based on results from the phase 1/2 EPCORE® NHL-1 clinical trial, which evaluated the safety and preliminary efficacy of EPKINLY in 127 adult patients with R/R FL who previously received a median of three lines of therapy and with 70% having double refractory disease. The results showed an overall response rate (ORR) of 82% and a complete response (CR) rate of 60%, including 67% of patients achieving minimal residual disease (MRD) negativity. Additionally, more than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., at a median follow-up of 14.8 months, median duration of response (DoR) was not reached). The study included prespecified subgroups representing patients with challenging-to-treat FL, including patients who were refractory to both anti-CD20 therapy and an alkylating agent, patients who were refractory to last prior treatment, and patients whose disease progressed within two years of first-line immunochemotherapy (POD24). These results were recently published in the Lancet Haematology.

    Common treatment-emergent adverse events (TEAEs) (=20%) from the FL cohort of the trial were injection site reaction, cytokine release syndrome (CRS), COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. For patients who received EPKINLY at the recommended 3 step-up dosage schedule, CRS was primarily low grade (40% Grade 1, 9% Grade 2). There were no grade 3 CRS events observed. The prescribing information has a Boxed Warning for serious or life-threatening CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity. Please see additional Important Safety Information below.

    “With this approval, patients whose follicular lymphoma has relapsed or is refractory to at least two or more lines of systemic therapy, now have the option to be treated with EPKINLY, which has demonstrated durable responses without mandatory hospitalization using a 3 step-up dosage regimen in this patient population in clinical trials,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “In just over a year, EPKINLY has received a second indication in the U.S., making it the first and only bispecific antibody approved to treat patients with diffuse large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy. The approved indications, along with the ongoing clinical development program, underscore the potential of epcoritamab to become a core therapy across B-cell malignancies.”

    “People living with follicular lymphoma are in need of additional options when their cancer returns,” said Lee Greenberger, Ph.D., Chief Scientific Officer at The Leukemia & Lymphoma Society. “Today’s approval is welcome news for patients, as it provides another tool in the physician arsenal for this difficult-to-treat form of cancer.”

    NCCN® Clinical Practice Guidelines
    The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for “B-Cell Lymphomas” were recently updated (Version 2.2024) to add EPKINLY as a Category 2A, preferred recommendation for third-line and subsequent therapy for patients with FL. This recommendation is based on uniform NCCN consensus that the intervention is appropriate.vi

    About the EPCORE® NHL-1 Trial
    EPCORE® NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate as assessed by an Independent Review Committee. Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of = Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.
  19. sheriff Grover 3 juli 2024 16:00
    Hi Merlijn , we moeten maar hopen dat de verkoper uit de markt is en we min of meer de bodem hebben gezien , dat is een beetje mijn gok . De tijd zal het leren of het de juiste move is geweest ... Maar nogmaals ik weet eigenlijk nog steeds niet waarom en zeker niet van harte ;o) gr SG
3.499 Posts
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