Argen-X

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ancaoli
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Re: Argen-X

Berichtdoor ancaoli » 16 Mei 2019 18:26

starkeeper schreef:Zou me niet verwonderen om eerst nog even te dalen om dan op 22 mei te knallen.

Of krijgen we een sell on the news/ no news?
Vaste Portefeuille:Gala, Exmar, WRN, Accentis, Global G, SocGen, Roularta, Biocartis, Argenx, Enwave, Agfa, Accsys,Pure Gold Mining



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ancaoli
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Re: Argen-X

Berichtdoor ancaoli » 16 Mei 2019 22:21

Sterk Argenx! In U.S. afgesloten op HOD en dit ondanks een zakkende beursindex op het einde van de sessie. Hele week trouwens al sterk bezig, waarschijnlijk door de aankondiging van de agenda van 22 mei. U.S. heeft trouwens de lead bij deze stijging; België volgt duidelijk de U.S. trend .
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Vaste Portefeuille:Gala, Exmar, WRN, Accentis, Global G, SocGen, Roularta, Biocartis, Argenx, Enwave, Agfa, Accsys,Pure Gold Mining

Bussie
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Re: Argen-X

Berichtdoor Bussie » 21 Mei 2019 15:44

De Amerikanen hebben door dat het morgen R&D-day is

Gentse strop
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Re: Argen-X

Berichtdoor Gentse strop » 21 Mei 2019 22:30

Mooi stijging op Nasdaq! Eindigen op net niet intraday high, 133,8 dollar, omgerekend 119,87 euro. Morgen kunnen we verder omhoog kijken, en om 14u30 Belgische tijd start de R&D-dag.

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Re: Argen-X

Berichtdoor buffalo1 » 22 Mei 2019 04:39


Gentse strop
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Re: Argen-X

Berichtdoor Gentse strop » 22 Mei 2019 07:07

argenx announces pipeline expansion and “argenx 2021” vision to build integrated immunology company at 2019 R&D Day



Expands pipeline with ARGX-117 and ARGX-118; two new pipeline candidates from its Innovative Access Program addressing first-in-class targets
Highlights formation of two global therapeutic franchises in neuromuscular and hematology with targeted first commercial launch in 2021
Appoints Wim Parys, M.D. as Chief Medical Officer, formerly of Janssen
May 22, 2019

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, will be hosting its second R&D Day today, Wednesday, May 22, 2019, in New York starting at 8:30am ET. During the event, argenx will present data on two new pipeline candidates that emerged from its Innovative Access Program (IAP) and will provide updates on the development plan of cusatuzumab (ARGX-110) in collaboration with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson. Today, argenx will also bring forward its “argenx 2021” vision, providing clarity on its strategy to become a fully integrated immunology company.

“At argenx we are making comprehensive investments across the organization and planning for nothing less than building the next great integrated immunology company, which we will carry out through our “argenx 2021” vision. We are putting all the elements in place for a sophisticated U.S. launch of efgartigimod for generalized myasthenia gravis patients, if approved. We are also working closely with Janssen to advance cusatuzumab into a broad development plan, starting with a first Phase 2 registration-directed trial in acute myeloid leukemia (AML) that is expected to start in the second half of 2019,” commented Tim Van Hauwermeiren, Chief Executive Officer of argenx.

“Today we will unveil two new and exciting candidates from our Innovative Access Program that will further enrich our immunology pipeline and provide us with ambitious therapeutic opportunities. As we strive to become a commercial organization, it is this R&D engine that is a key success differentiator of argenx, having allowed us to repeatedly identify first-in-class targets from our academic collaborators and translate these important targets into significant and sustainable value for our company and for our stakeholders.”


argenx 2021 Vision

argenx today is announcing its plan to become a fully integrated, novel immunology company through its “argenx 2021” vision, which will include the building of two commercial franchises in neuromuscular and hematology. Within the two franchises are currently three expected pipeline candidates, including:

Efgartigimod (ARGX-113) with the potential to address generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy within neuromuscular, and immune thrombocytopenia within hematology;
Cusatuzumab with the potential to address acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) and other hematological malignancies within the hematology franchise;
Newly announced ARGX-117 with the potential to address multiple indications within both franchises.
By the end of 2021, argenx expects to launch efgartigimod in the U.S. in its first indication gMG, if approved. Through the building of commercial franchises, argenx plans to leverage capabilities and an organizational footprint for subsequent potential launches across its broad immunology pipeline.


Pipeline Expansion

argenx today announced the addition of two new therapeutic candidates, ARGX-117 and ARGX-118, to its proprietary antibody pipeline. Both emerged from argenx’s IAP, in which it collaborates closely with academic experts, bringing the argenx cutting-edge antibody discovery technologies to the heart of novel target research.

ARGX-117 Targeting C2

ARGX-117 is a next-generation complement-targeting antibody against C2, an important component of both the classical and lectin pathways in the complement cascade. ARGX-117 has the following differentiated features:

Unique design to precisely intervene at C2 in the complement cascade with the intention to balance optimal tolerability and activity
Expected attractive pharmacokinetic and pharmacodynamic properties derived from proprietary antibody engineering that could potentially translate to convenient dosing schedule
Pipeline-in-a-product opportunity with potential therapeutic applications in an array of complement-mediated diseases that fit within established franchises in neuromuscular and hematology, as well as in kidney indications
ARGX-117 was developed under a collaboration with the University Medical Center Utrecht/Broteio Pharma and was exclusively licensed by argenx in 2018. First-in-human clinical studies are expected to start in the first quarter of 2020.

argenx also announced that it has exercised its second exclusive license to Halozyme’s ENHANZE® technology for ARGX-117 target C2. Under the terms of the collaboration, argenx will access Halozyme’s well-established subcutaneous delivery technology for ARGX-117 to provide dosing optionality to patients. In exchange, argenx will pay Halozyme $10M for access to the second target in addition to potential future payments of up to $160 million, subject to achievement of specified milestones. Halozyme will also receive mid-single digit royalties on any future sales of commercialized products.

ARGX-118 Targeting Galectin-10

argenx is announcing today that it has exercised its option to exclusively acquire rights to ARGX-118, a highly differentiated antibody against Galectin-10, the protein of Charcot-Leyden crystals, which are implicated as a major contributor to severe asthma and to the persistence of mucus plugs. ARGX-118 has the following differentiated features:

Acts on novel target intended to address mucus plugging, a large unmet need in airway inflammation
Unique mechanism of action with observed crystal-dissolving properties
Broad potential in severe airway inflammation diseases where mucus plugging plays a key role, including lung attack or asthma exacerbation, allergic bronchopulmonary aspergillosis, and chronic rhinosinusitis with nasal polyps
ARGX-118 was developed under a collaboration with VIB, a life sciences research institute based in Flanders, Belgium. The molecule is in the final stages of lead optimization work.


Appointment of Chief Medical Officer

argenx announced today the appointment of Wim Parys M.D. as Chief Medical Officer effective July 1, 2019. Dr. Parys will succeed outgoing Chief Medical Officer Nicolas Leupin, M.D. who will be departing from the Company. In his role, Dr. Parys will lead argenx’s clinical development, clinical operations, regulatory affairs, pharmacovigilance and project management. Dr. Parys has served as an R&D consultant to argenx since February 2019.

Dr. Parys held several R&D leadership roles of increasing responsibility at Janssen, J&J and Tibotec, including Head of Development at Tibotec where he established and led Tibotec Inc. USA and Head of Development of Janssen’s Infectious Diseases and Vaccines therapeutic area. Through his career, he led the development and regulatory submission of seven now-approved drugs. Most recently, Dr. Parys served as Head of R&D of the Global Public Health group of Janssen.

“With over 25 years of experience leading successful clinical programs and sophisticated regulatory submissions, we are confident Wim is the right leader to advance our rich pipeline at this pivotal time of growth for argenx. We believe his strategic vision will strengthen our clinical development activities and provide us key guidance as we advance to filing for our first drug approval,” continued Mr. Van Hauwermeiren.

“We extend our deepest gratitude to Nicolas for his significant contributions and leadership to argenx over the last four years. He joined the Company as we were launching the first efgartigimod patient trials and his innovative thinking led to the successful late-stage results for this molecule as well as progress throughout our pipeline. We’re confident his talents will lead to continued accomplishments.”


Cusatuzumab Development Plan

argenx today announced that its partner Janssen intends to initiate in the second half of 2019 its first Phase 2 and registration-directed clinical trial of cusatuzumab under the companies’ strategic collaboration. Cusatuzumab is an anti-CD70 monoclonal antibody for AML, high-risk MDS and other hematological malignancies. Details of the trial are as follows:

Expected to enroll up to 150 patients with previously untreated AML who are not eligible for intensive chemotherapy
Two-part trial: a dose selection part followed by a safety and efficacy part at the selected go-forward dose
In the first part of the study, patients will be randomized to two dose levels of cusatuzumab (10mg/kg and 20mg/kg) in combination with azacytidine. The second part of the study is an expansion cohort at the selected dose to evaluate efficacy and safety of the combination

R&D Day Details

argenx will host its second R&D day today, Wednesday, May 22, 2019, in New York with presentations starting at 8:30am ET.

In addition to argenx management, guest speakers for the event will include:

Prof. Erik Hack, M.D., Ph.D., Professor of Immunology, University Medical Center Utrecht
Prof. Ludo van der Pol, M.D., Ph.D., Associate Professor, Utrecht University, Neurologist, University Medical Center Utrecht
Prof. Bart Lambrecht, M.D., Ph.D., Director, VIB Center for Inflammation Research at Ghent University
Dr. Rafael N. Villicana, M.D., Associate Professor, Medical Director, Kidney Transplantation, Loma Linda University Medical Center
Webcast information:

A live webcast of today’s presentation will be available on the Company’s website at http://www.argenx.com or via this link. A replay of the webcast will be available for 90 days following the presentation.
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jack.
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Re: Argen-X

Berichtdoor jack. » 22 Mei 2019 08:13

Uitbreiding pijplijn Argen-X
22 mei 2019 07:38 Redactie

(ABM FN) Argen-X gaat woensdag twee nieuwe behandelingen en zijn ‘Argen-X 2021’-visie presenteren tijdens haar tweede R&D dag in New York. Dit meldde het bedrijf woensdag voorbeurs.

“Vandaag onthullen we twee nieuwe en opwindende kandidaten van ons Innovative Access Program die onze immunologische pijplijn verder zal verrijken en ons ambitieuze therapeutische mogelijkheden zal bieden”, aldus CEO Tim Van Hauwermeiren in een toelichting.

De ARGX-117 en de ARGX-118 zijn twee therapeutische kandidaten die Argen-X aan zijn pijplijn toevoegt. ARGX-117 is een volgende generatie complementaire antilichamen tegen C2, een belangrijk onderdeel van zowel de klassieke als de lectinewegen in de complementcascade. Daarbij besloot Argen-X tot een tweede exclusieve licentie voor Enhanze-technologie van Halozyme. Daarvoor betaalt het in eerste instantie 10 miljoen dollar en bij het halen van bepaalde mijlpalen maximaal 160 miljoen dollar. Ook zal het royalties moeten afstaan.

ARGX-118 is een sterk gedifferentieerd antilichaam tegen Galectin-10 dat een belangrijke bijdrage levert aan ernstige astma en aan de persistentie van slijmpluggen.

Met de ‘Argen-X 2012’-visie wil de biopharmaceut zich ontwikkelen in een volledig geïntegreerd en nieuw immunologiebedrijf, die de bouw van twee commerciële franchises in neuromusculaire en hematologie zal omvatten. Binnen de twee franchises zijn er momenteel drie verwachte pijplijnkandidaten: Efgartigimod, Cusatuzumab en de ARGX-117.

Argen-X heeft ook Wim Pays als nieuwe Chief Medical Officer benoemd. Hij zal op 1 juli in dienst treden ter vervanging van Nicolas Leupin.

Lees meer op: https://beursig.com/beursnieuws/uitbrei ... n-argen-x/
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Re: Argen-X

Berichtdoor Pasti » 22 Mei 2019 08:55

Eigenlijk dus niet echt nieuwtjes wat de koers op KT nog zal doen verder stijgen, mijn bescheiden mening iedergeval. We zijn natuurlijk de laatste dagen al behoorlijk opgelopen, in het vooruit op deze R&D dag. Denk dat velen misschien toch wel iets groters hadden verwacht, mogelijk aankondiging van een nieuwe deal etc.

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jack.
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Re: Argen-X

Berichtdoor jack. » 22 Mei 2019 09:05

Argenx (advies KBC Securities: "Kopen" - koersdoel 130,00 EUR)
NIEUWS | Argenx informeert de markt over zijn langetermijnstrategie voor 2021, met het oog op verdere groei naar een volledig geïntegreerd immunologiebedrijf, in het kader van de R&D Day die het vandaag in New York organiseert. Tegen 2021 wil het bedrijf twee commerciële concessies (neuromusculaire, hematologie) creëren om de lancering van 3 antilichamenprogramma's te ondersteunen. Onder voorbehoud van goedkeuring zou efgartigimod tegen eind 2021 gelanceerd worden op de Amerikaanse markt, voor de behandeling van gegeneraliseerde Myasthenia Gravis (gMG).
Wat betreft de samenwerking met Janssen rond cusatuzumab zal in de tweede helft van 2019 een op registratie gerichte fase II-studie worden opgestart. 150 patiënten met onbehandelde AML die niet in aanmerking komen voor chemo zullen worden ingeschreven. Er zouden ook nog meer studies volgen in samenwerking met Janssen.
Twee activa worden aan de pijplijn toegevoegd: enerzijds ARGX-117 voor de neuromusculaire & hematologische franchise (incl. nierziekten), ontwikkeld door de samenwerking met Broteio, waarvoor in het eerste kwartaal van 2020 een First-In-Human-studie wordt opgestart; anderzijds ARGX-118 gericht op luchtwegontsteking veroorzaakt door slijmophoping.
Op organisatorisch vlak wordt Dr. Wim Parys vanaf 1 juli de nieuwe CMO, ter vervanging van Nicolas Leupin. Dr. Parys bekleedde verschillende functies bij Janssen, J&J, Tibotec (inclusief de oprichting van Amerikaanse afdelingen) en leidde de indiening van max. 7 productgoedkeuringen.
De visie van KBC Securities: Veel nieuws deze ochtend, ter ondersteuning van de verdere groei van het bedrijf naar een volledig immunologiebedrijf met een geïntegreerde commerciële structuur en een eerste productlancering op de Amerikaanse markt verwacht voor 2021. Analiste Sandra Cauwenberghs bevestigt het koersdoel en advies voor de aandelen.
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Re: Argen-X

Berichtdoor buffalo1 » 22 Mei 2019 09:07

Hoogste 52 w go go 120 nu


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