Argenix 2015 nieuwe parel?

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Onder dank van de redactie een draadje over nieuwkomer ArgenX, opgezet en geleid door oud MT-ers van Ablynx, die op basis van de nanobodies (VHH-only) van lama's simpele humane antibodies maken die beter zijn of worden dan de competiters. Recent bericht:
Mar 4, 2015: arGEN-X Expands Preclinical Pipeline with ARGX-115: A Novel Simple Antibody™ for Cancer Immunotherapy
ARGX-115 re-activates immunity to cancer
First-in-class therapeutic antibody targeting GARP, a novel immune checkpoint
First candidate to be licensed under Company’s Innovative Access Program
Breda, the Netherlands/Ghent, Belgium - arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it has exercised its option to exclusively license a first-in-class, preclinical therapeutic antibody candidate, now ARGX-115, to target GARP, a novel immune checkpoint with potential in cancer immunotherapy. ARGX-115 was discovered under arGEN-X’ Innovative Access Program with de Duve Institute / Université Catholique de Louvain (UCL) / WELBIO (BE).

“Cancer immunotherapy continues to be one of the most exciting approaches to treating cancer, but also one that is rapidly evolving. Application of immune checkpoint inhibitors have come more into focus, specifically in combination regimens in order to achieve the best possible patient outcomes. Preclinical results illustrate the exciting potential of ARGX-115 as a first-in-class antibody targeting GARP, a novel immune checkpoint and a target we believe to play a key role in the ability of tumors to escape the patient’s immune system,” commented Tim Van Hauwermeiren, CEO of arGEN-X. “Combining the expertise of the de Duve Institute/UCL/WELBIO in cancer immunology with arGEN-X’s proprietary SIMPLE AntibodyTM platform and antibody know-how creates a powerful partnership that is ideally positioned to lead the discovery of differentiated antibodies in immune oncology. We expect to initiate further preclinical studies of ARGX-115 in the near-term to illustrate its potential as future cancer immunotherapy.”

ARGX-115 RE-ACTIVATES IMMUNITY TO CANCER
In cancer patients, tumors grow as they escape from immune surveillance. Tumors can suppress the immune system by co-opting different immunosuppressive cells such as regulatory T-cells (Tregs), which exert contact-dependent inhibition of immune cells through the production of active TGF-ß. On Treg cell surface, the membrane protein GARP regulates the production of active TGF-ß. Preclinical studies completed at de Duve Institute/UCL/WELBIO show ARGX-115 can inhibit the immunosuppressive activity of human Tregs by binding to GARP-inactive TGF-ß complex and preventing release of active TGF-ß.

EXCLUSIVE LICENSE FOR GARP PROGRAM
ARGX-115 results from a collaboration between arGEN-X and de Duve Institute/UCL/WELBIO, initiated in November 2013, leveraging the SIMPLE AntibodyTM platform and the experience of de Duve Institute/UCL/WELBIO in cancer immunology, in order to create and validate functional leads and druggable targets in oncology. Under the collaboration, arGEN-X has exercised its option to exclusively in-license the GARP program for further development and commercialization as part of arGEN-X’ proprietary product pipeline.

ABOUT THE INNOVATIVE ACCESS PROGRAM
arGEN-X’ Innovative Access Program leverages the proven power of the SIMPLE Antibody™ platform in creating highly differentiated antibodies across multiple therapeutic areas. Through collaboration with academic centers of excellence and emerging biotech companies, arGEN-X will provide access to its antibody discovery technologies and offer technical support and proprietary know-how where needed. Deal structures are designed to be flexible.
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Proost op je nieuwe forum Fly

KBC koersdoel 2015 / 10 euro inmiddels bereikt .

Even afwachten op verdere ontwikkelingen .
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Mar 18, 2015: arGEN-X Reports Fourth Quarter Business Update And Full Year 2014 Financial Results
Management to host conference call today at 6 pm CET / 1 pm EDT

Breda, the Netherlands / Ghent, Belgium arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced its fourth quarter business update and the consolidated full year results for 2014, which have been prepared in accordance with IFRS as adopted by the European Union.

The FY results will be discussed during a conference call and webcast presentation today at 6 pm CET / 1 pm EDT. To participate in the conference call, please select your phone number here, and use the confirmation code 92395735. The webcast may be accessed on the homepage of the arGEN-X website at www.argen-x.com or by clicking here.

OPERATIONAL HIGHLIGHTS

Advancement of ARGX-110 into expansion cohorts as part of its Phase 1b study in CD70-positive cancer patients with either hematological or solid tumors to further evaluate safety and efficacy and to select indications for study in Phase 2 clinical development.
Enrolment completed of first cohort of 15 patients with CD70-positive hematological malignancies and 15 patients with CD70-positive solid tumors into a Phase 1b expansion trial.
Initiation of clinical efficacy evaluation of ARGX-110 in dedicated expansion cohort of patients with relapsed/refractory CD70-positive T-cell lymphomas, as part of broader Phase 1b study.
Acceptance of Investigational New Drug (IND) Application to evaluate ARGX-110 in Waldenström’s macroglobulinemia (a rare, incurable B-cell lymphoma).
Partnership with the Leukemia Lymphoma Society on the development of ARGX-110 for the treatment of Waldenström’s macroglobulinemia
Presentation of positive preclinical data on ARGX-110 in a chronic myelogenous leukemia (CML) model demonstrating potential of ARGX-110 in reversing resistance to tyrosine kinase inhibitors. Data were presented in December 2014 at ASH (American Society of Hematology).
Positive preclinical data for ARGX-113 supporting its use as a potential breakthrough concept for the treatment of severe autoimmune diseases.
Collaboration with Bayer, leveraging arGEN-X’ SIMPLE Antibody™ technology for the discovery and development of first-in-class antibodies addressing complex targets across multiple therapeutic areas.
Long-term strategic alliance with Shire Pharmaceuticals where arGEN-X focus its suite of human antibody discovery technologies on multiple targets aligned with Shire’s therapeutic focus.
Key patents relating to ARGX-110 and ARGX-111 granted in the US, providing patent protection for both until 2031-2032 and allowing up to five additional years of patent term extension.
FINANCIAL HIGHLIGHTS

Successful Initial Public Offering (“IPO”) on Euronext Brussels raising total gross proceeds of EUR 41.8 million.
Received two preclinical milestone payments under collaboration with Shire.
Operating loss totaled EUR 10.7 million in 2014 compared with EUR 6.2 million in 2013.
Net loss for 2014 increased to EUR 10.3 million compared with EUR 6.1 million in 2013, due to the costs of advancing the Group’s clinical pipeline.
On December 31, 2014 the Group’s cash, cash equivalents and financial assets amounted to EUR 56 million compared with EUR 23.2 million on December 31, 2013.
POST-PERIOD HIGHLIGHTS

Launch of Innovative Access Program (“IAP”), providing SIMPLE Antibody™ platform to academic centers of excellence and emerging biotech companies. First collaborations in cancer immunotherapy and dyslipidemia.
First program in-licensed from IAP for further development: ARGX-115, a first-in-class antibody targeting GARP for cancer immunotherapy.
Multi-product commercial license agreement with Lonza for the production of arGEN-X’ therapeutic antibodies.
Commenting on the 2014 results, Tim Van Hauwermeiren, CEO of arGEN-X, said: “2014 has been a transformational year for arGEN-X. We made significant progress within our clinical pipeline progressing ARGX-110 towards clinical proof-of-concept in important solid and hematological tumor indications including T-cell lymphoma and Waldenström’s macroglobulinemia. We also advanced and expanded our preclinical pipeline adding more depth to our development plan. Our business development activities were further validated the expected utility of our SIMPLE AntibodyTM platform with the deepening of partnerships as with Shire and the initiation of new ones as with Bayer and completed a successful IPO on Euronext Brussels,” comments Tim Van Hauwermeiren.

“With a well-balanced pipeline of wholly-owned and partnered clinical assets and several innovative early stage programs in oncology and auto-immune diseases, we feel we have positioned the Company for future success. We are entering a period of significant growth during which we intend to remain focused on our initial business strategy, on the execution of our pipeline programs, and on delivering added value to all our stakeholders.”
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Apr 9, 2015: arGEN-X Opens Expansion Cohort in Phase 1b Study of ARGX-111 in Patients with MET Amplified Cancers
Breda, the Netherlands / Ghent, Belgium – arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it has advanced ARGX-111, a best-in-class highly differentiated SIMPLE Antibody™ targeting c-MET driven malignancies, into the safety and efficacy expansion part of its Phase 1b study. The objective of the expansion cohort is to further characterize the safety of ARGX-111 in cancer patients with MET amplified tumors, and to evaluate efficacy signals in order to select the indications to be studied in Phase 2 clinical development.

“We are pleased to have selected the dose of ARGX-111 to move forward into safety expansion cohort of the study. We based the selection on the results of the dose escalation portion of the study conducted in patients pre-screened for cancers with over-expression of c-Met,” commented Alain Thibault, M.D., Chief Medical Officer at arGEN-X. “Biological activity was illustrated especially in the context of MET amplification. We will recruit these types of patients for the upcoming expansion cohort and we expect to report interim data in the second half of 2016.”

The full data from the dose escalation part of the Phase 1b study will be presented at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, 29 May – 2 June, in Chicago, IL, USA.
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Apr 23, 2015: arGEN-X Announces Publication on Therapeutic Potential of ARGX-115 in Cancer Immunotherapy
Results on ARGX-115 published in Science Translational Medicine indicating inhibition of immune checkpoint GARP in in vivo mouse model

Breda, the Netherlands/Ghent, Belgium - arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, and de Duve Institute / Université Catholique de Louvain (UCL) / WELBIO (BE) today announced the publication of new data showing that the preclinical therapeutic antibody ARGX-115 blocks the activity of GARP, a novel immune checkpoint. These findings were published in the leading journal Science Translational Medicine and suggest potential for the antibody candidate in cancer immunotherapy.

“Combining the expertise of the de Duve Institute/UCL/WELBIO in cancer immunology with arGEN-X’s proprietary SIMPLE AntibodyTM platform led to the discovery of ARGX-115, a highly differentiated monoclonal antibody that inhibits the novel immune checkpoint GARP,” commented Hans de Haard, Chief Scientific Officer of arGEN-X.

“We believe there is potential for ARGX-115 as a future cancer immunotherapy as it inhibits specific downstream effects of regulatory T-cells (Tregs), a known contributor to cancer progression through the inhibition of anti-tumor immune responses. Additionally, there may be possibilities to use ARGX-115 in combination with tumor vaccines or other therapeutic antibodies in order to improve the efficiency of cancer immunotherapy regimens.”

Sophie Lucas, leading the research group at de Duve Institute working on ARGX-115, emphasizes: “This monoclonal antibody is the first therapeutic agent to show an inhibitory activity on the immunosuppressive function of human Tregs. The relevance of GARP in converting inactive TGF-beta into its active form on Tregs was now convincingly demonstrated in in vitro and in vivo models by the neutralizing antibody. ARGX-115 highlights the importance of active TGF-beta production in immunosuppression by human Tregs, and provides means to inhibit this immunosuppression in vivo.”

ARGX-115 Re-activates Immunity to Cancer

In cancer patients, tumors grow as they escape from immune surveillance. Tumors can suppress the immune system by co-opting different immunosuppressive cells such as Tregs, which exert contact-dependent inhibition of immune cells through the production of active TGF-beta. On the Treg cell surface, membrane protein GARP regulates the production of active TGF-beta. Preclinical studies completed at de Duve Institute/UCL/WELBIO show ARGX-115 can inhibit the immunosuppressive activity of human Tregs by binding to GARP in complex with inactive TGF-beta and preventing release of active TGF-beta.

Science Translational Medicine Publication

Cuende J. et al., Science Translational Medicine, 2015 April 22, Vol 7, Issue 284
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Zo even naar mijn eigen forumpje; heb aandelen bijgekocht want met dit MT, hun simple body platform, 50M euro in kas en de lopende deals moet dit ei wel een keer gaan uitkomen
voda
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Nettoverlies biotech arGEN-X verdubbelt

Cashpositie blijft solide


Biotechbedrijf arGEN-X, dat middelen ontwikkelt tegen kanker en auto-immuniteitsziekten, verdubbelde het eerste kwartaal zijn inkomsten, maar zag ook zijn verlies oplopen.

Het Gentse arGEN-X boekte over de eerste drie maanden van dit jaar 1,83 miljoen euro inkomsten tegenover 0,84 miljoen een jaar eerder. Het nettoverlies liep verder op van 1,86 tot 2,98 miljoen euro. Tijdens die periode joeg de biotechonderneming er 3,8 miljoen cash door, waardoor er op 31 maart nog wel een comfortabele 52,16 miljoen liquiditeiten op de bankrekening stonden.

Tijdens het kwartaal sloot arGEN-X een commerciële licentie voor verschillende producten met Lonza voor de productie van therapeutische antilichaampjes van arGEN-X. Op de algemene vergadering van vorige woensdag werd J. Donald deBethizy aangesteld als onafhankelijk bestuurder. Bruno Montanari en Harrold van Berlingen verlaten de raad van bestuur. Pam Klein wordt adviseur bij die raad van bestuur.

Bron: DeTijd
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voda dank en met nog steeds een solide bankrekening kunnen zijn hun platform verder uitbouwen en zullen ze zeker een breder pallet aan co-developing pharma en biotech partners gaan krijgen. Overweeg nog verder in te stappen want met waardering van 130M en 50M in kas nog niet al te hoge waardering voor platform en potentie antibodies
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Beste Hoebeet,

Dank en interessant. Zoals eerder gezegd, moet dit nog lang rijpen, maar heb een absoluut vertrouwen in dit MT en hun slimme simple body platform. Dat de CD-70 target for waldstrom lymphoma nu niet de meest handige route is door een zojuist concurrerende antistof die wordt voorgeschreven, is wel jammer maar met een andere indicatie kan dit zeker verder. Daarbij zitten er veel meer simple bodies in de pijplijn.
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May 19, 2015: arGEN-X awarded €1.5 million IWT grant to advance the application of NHance® Fc modifications in therapeutic antibodies
Breda, The Netherlands / Ghent, Belgium, – arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it has received a € 1.5 million grant from the Institute for the Promotion of Innovation by Sciences and Technology in Flanders (IWT). This grant will be used to advance and commercialize the application of the NHance® Fc modifications in therapeutic antibodies.
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May 21, 2015: arGEN-X and LEO Pharma Enter into Alliance to Develop Antibody-based Treatments for Skin Conditions
Breda, the Netherlands/Ghent, Belgium and Ballerup, Denmark – arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, and LEO Pharma A/S, a global healthcare company dedicated to helping people achieve healthy skin, today announced an alliance in which they will collaborate to develop innovative antibody-based solutions for the treatment of chronic inflammation underlying many skin conditions.

Under the terms of the agreement, LEO Pharma receives exclusive access to an existing arGEN-X antibody currently in preclinical development for inflammation-related skin diseases. arGEN-X receives pre-IND payments of EUR 4.5 million, including an upfront payment. arGEN-X will also receive clinical, regulatory, and sales milestone payments that may total upward of EUR 100 million, as well as tiered, potentially double digit royalties on resulting products. The companies will co-fund product development costs up to clinical trial application (CTA) filing. Additional terms and financial details of the collaboration were not disclosed.

“We see huge potential in this new partnership in harnessing the complementary expertise of both companies: arGEN-X’ advanced knowledge and capabilities in therapeutic antibody development and LEO Pharma’s global expertise in bringing products to market that meets the needs of dermatology patients,” said Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X. “We see LEO Pharma’s selection of our program and approach to antibody creation as an important validation of our position in the therapeutic antibody space. This collaboration is central to arGEN-X’ strategy to be the preferred antibody partner of global leaders in specific disease areas beyond our own focus.”
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Brussels - Op 2015-05-21 (her)starten de analisten van Petercam met het volgen van arGEN-X (ISIN: NL0010832176 / Mnemo: ARGX) met een koopadvies. Het 12-maands koersdoel is vastgesteld op 13.0 EUR

In 2014 bedroeg de koerswinstverhouding (berekend met de ultimo slotkoers van het aandeel in 2014) -5.56.
De forward PE (de slotkoers van 20 May 2015 gedeeld door de winst per aandeel over 2014) bedraagt -6.92.
Over 2014 rapporteerde het bedrijf een omzet van 3.75 miljoen EUR.
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May 29, 2015: arGEN-X presents preliminary efficacy and expanded safety data from Phase I trial of ARGX-111 at ASCO
Safe dose established for next stage studies
Biological activity observed in MET-amplified cancer patient
Breda, the Netherlands/Ghent, Belgium – arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, will present the results of a Phase I, first-in-human dose escalation study of ARGX-111, a monoclonal antibody targeting c-Met in patients with solid tumors, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The company will present an abstract of the data on Saturday, May 30th, from 08:00am – 11:30am as part of the poster session on Development Therapeutics.

ARGX-111 is a c-Met-targeting human monoclonal SIMPLE Antibody™ that modulates all known mechanisms of action of the receptor. As well as the blocking of both ligand-dependent and -independent signaling through c-MET, ARGX-111 benefits from POTELLIGENT®-enhanced Antibody Dependent Cellular Cytotoxicity (ADCC), which drives the immune system to destroy c-MET positive cells of the primary tumor and the circulating tumor cells that are responsible for metastasis; and from NHance®, which drives tissue penetration in the hunt for tumor metastasis. This unique combination results in a potentially best-in-class drug candidate for
c-Met therapies.

ARGX-111 was investigated in a Phase I dose escalation study in 18 patients with advanced solid tumors over-expressing c-Met. The study yielded the initial safety profile and the dosing regimen for the next stage of clinical investigation. The maximum tolerated dose (MTD) was determined at 3 mg/kg every 3 weeks. Biological activity was clearly illustrated in a patient with gastric MET amplified cancer.

“What is exciting about these ARGX-111 results is that the Phase I clinical data are a nice translation of the preclinical observations including successful depletion of circulation tumor cells and a marked impact on metastatic lesions in bone and lymph compartments ,” said Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X. “Together with the established safety profile, we have strong support for the further development of ARGX-111 in MET amplified malignancies.”

Recruitment of MET amplified patients for the safety expansion cohort is ongoing. arGEN-X expects to report interim data on this safety expansion cohort in the second half of 2016.
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nee. blijf rustig zitten; ik zie dit platform veel en veel kansijker als bijv gala waar ik ook inzit die eigenlijk alleen (wel nu succesvol) een slimmere manier hebben door small molecules te screenen op patieten materiaal en primaire cellen ipv tumorcel lijnen..
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Jun 18, 2015: Preliminary Phase I results of ARGX-110 in patients with T-cell lymphomas presented at ICML
Breda, the Netherlands/Ghent, Belgium – arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies to treat cancer and severe autoimmune diseases, today presented preliminary results from an ongoing Phase I study of ARGX-110 in patients with T-cell lymphoma at the 13th International Conference on Malignant Lymphoma (Lugano, Switzerland; 17-20 June, 2015) in the ‘Novel Agents’ session.

ARGX-110 has been investigated in a Phase I patient cohort with advanced lymphomas expressing CD70. Of eight patients with relapsed/refractory T-cell lymphomas in this cohort, a biologic response was observed in three patients: in two patients with cutaneous T-cell lymphoma (Sézary syndrome), one of which had stable disease for more than six months; and in one patient with angioimmunoblastic T-cell lymphoma.

“Our strategy is to use this Phase I study to identify orphan cancer indications where ARGX-110 shows clinical benefit and then to enrich our study population with these patients to establish clinical proof of efficacy,” said Tim Van Hauwermeiren, Chief Executive Officer of arGEN-X. “The results we have seen to-date with ARGX-110 in relapsed/refractory CD70+ T-cell lymphoma patients provides compelling evidence to support its further development in these indications.”

An oral presentation of the results entitled “ARGX-110, a novel monoclonal antibody targeting CD70, is associated with biological activity in patients with relapsed/refractory T-cell lymphomas” was presented by Dr Marie Maerevoet from the Institut Jules Bordet (Brussels, Belgium).

About ARGX-110

ARGX-110 is a first-in-class monoclonal antibody that potently blocks CD70-induced tumor proliferation and tumor escape from immune surveillance. In addition, the POTELLIGENT®-enhanced antibody-dependent cellular cytotoxicity (ADCC) of ARGX-110 enables selective destruction of CD70-positive tumor cells. CD70 is overexpressed in the majority of cancer patients tested to date. In the initial dose-escalation of the Phase I study, ARGX-110 demonstrated a favorable safety profile with no dose-limiting toxicities seen in the 26 patients treated. ARGX-110 was well tolerated at doses between 0.1 to 10 mg/kg administered intravenously once every three weeks, and the maximum tolerated dose was not reached.
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Jul 30, 2015: arGEN-X and University of Bern enter into license agreement to develop ARGX-110-based combination therapies for treatment-resistant cancers
Collaboration demonstrates potential of ARGX-110 in overcoming treatment resistance
in chronic myelogenous leukemia (CML)
Preclinical results published in Science Translational Medicine
Breda, the Netherlands/Ghent, Belgium - arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases and the Clinical Research Department of the University of Bern announce an exclusive license agreement enabling arGEN-X to develop and commercialize ARGX-110-based therapies to overcome treatment resistance mechanisms in hematologic tumors.

The license agreement has arisen from a highly productive collaboration between the two groups, jointly announced in December 2014 at the annual ASH (American Society of Hematology) conference. Ongoing preclinical work has demonstrated the potential use of ARGX-110 to overcome imatinib resistance in chronic myelogenous leukemia (CML), data which are published today in the leading journal Science Translational Medicine.

“The multi-faceted clinical potential of ARGX-110 in CD70 positive tumors is unfolding rapidly as we progress through preclinical and clinical development. Together with our collaborators in Bern, our discovery that CD70 blockade overcomes resistance to tyrosine kinase inhibitor treatment in CML patients offers an exciting in-road into combination therapy with ARGX-110. Through this collaboration, we have built a deeper understanding of the role of leukemia stem cells (LSCs) in CML and how CD70 plays a role in establishment of resistance to standard of care therapies,” commented Hans de Haard, Chief Scientific Officer of arGEN-X.

“LSCs are responsible for the development of imatinib resistance. This resistance is caused by imatinib-dependent increase of CD70 expression which signals through its known receptor, CD27, resulting in the alternative activation of the Wnt signaling pathway. Combination therapy of imatinib and CD70 blockade has been shown to eliminate LSCs both in a murine CML model and in CML tumor xenografts,” emphasize Carsten Riether and Adrian Ochsenbein, who are leading the research project at the University of Bern.
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