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Aandeel VALERIO TX PSE:ALVIO.FR, FR0010095596

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Onxeo 2018

129 Posts
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  1. sp1946 18 oktober 2018 14:35
    Staat wel mooi tussen die grote jongens. Onxeo als ""leading player"".

    Global Thymic Carcinoma Treatment Market 2018 Merck & Co., Inc., Novartis AG, Onxeo SA, Sumitomo Dainippon Pharma Co.

    Shivaji October 18, 2018

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    Leading Thymic Carcinoma Treatment Industry Players Included In The Report Are: Merck & Co., Inc., Novartis AG, Onxeo SA, Sumitomo Dainippon Pharma Co., Ltd., Taiwan Liposome Company, Ltd., Tiziana Life Sciences Plc
    nt

  2. sp1946 18 oktober 2018 20:21
    Onxeo to Present Overview of AsiDNA™ for Treatment of Solid Tumors at DNA Damage Response Therapeutics Summit 2019

    Paris, October 18, 2018 – 6:30 pm CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology, targeting tumor DNA Damage Response (DDR) to fight resistant cancers, today announced that the Company was invited to present an overview of AsiDNA™ for the treatment of solid tumors at the 2nd DNA Damage Response Therapeutics Summit (DDRTS) to be held January 29-31, 2019, in Boston, MA.
    This leading industry summit provides the opportunity to gain exclusive insights on the latest innovations in the field of tumor DNA Damage Response. The presence of prominent pharmaceutical groups and research institutions testifies to the attractiveness of this rapidly growing field.
    Onxeo will present an overview of AsiDNA™, the Company’s first-in-class compound targeting tumor DNA break repair pathways, during a session entitled, “New Developments in PARP Inhibitors & Novel DDR Pathway Targets.”
    Françoise Bono, Chief Scientific Officer of Onxeo, said: “AsiDNA™ has shown unique properties in translational research, notably its ability to prevent resistance to PARP inhibitors and to potentiate their activity in cancer cells, regardless of genetic mutation status. Its strong synergy with DNA-damaging agents, such as chemotherapies and PARP inhibitors, could also open new therapeutic options in difficultto-treat cancers. We are pleased to have been selected to present at this benchmark event among the world’s most recognized stakeholders in DNA Damage Response. This is the ideal forum to update the industry, scientific and clinical experts on the recent clinical development progress achieved with AsiDNA™, a highly-differentiated molecule acting upstream of multiple DNA damage response pathways.”

    Session: New Developments in PARP Inhibitors & Novel DDR Pathway Targets Date: Wednesday, January 30, 2019 Time: 2:00 pm Location: Revere Hotel Boston Common, 200 Stuart St., Boston, MA 02116 Onxeo’s presentation: AsiDNA™, A First-in-Class Decoy Oligonucleotide Targeting DNA Repair to Kill Tumor Cells • AsiDNA™ is an innovative global DNA damage response inhibitor preventing recruitment of enzymes involved in DSB and SSB repair at the damage site • AsiDNA™ is synergistic with PARP inhibitors, prevents and reverses PARPi-acquired resistance • Recent outcomes from the phase 1 clinical study of AsiDNA™


    For further information, please visit the DNA Damage Response Therapeutics Summit website.



    PRESS RELEASE

    2 / 2
    About Onxeo
    Onxeo (Euronext Paris, NASDAQ Copenhagen: ONXEO) is a clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR). The Company is focused on bringing early-stage first-in-class or disruptive compounds (proprietary, acquired or in-licensed) from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners. Onxeo is developing AsiDNA™, a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a unique decoy & agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. AsiDNA™ is currently being evaluated for systemic (IV) administration in advanced solid tumors in the DRIIV-1 phase I study (DNA Repair Inhibitor administered IntraVenously). AsiDNA™ is the first compound generated from platON™, the Company’s proprietary chemistry platform of decoy oligonucleotides dedicated to generate new innovative leads and broaden Onxeo’s pipeline. Onxeo’s portfolio also includes belinostat, an HDAC inhibitor (epigenetics). Belinostat is already conditionally FDAapproved in the US as a 2nd line treatment for patients with peripheral T cell lymphoma and marketed in the US by Onxeo’s partner, Spectrum Pharmaceuticals, under the name Beleodaq® (belinostat IV form). For further information, please visit www.onxeo.com
  3. [verwijderd] 19 oktober 2018 10:26
    Dank sp1946 voor al je Onxeo bijdragen.

    Gisteren en vandaag aandelen Onxeo gekocht.
    Mijn portefeuille beslaat voor 85% uit Galapagos LT.

    Volg Onxeo al langer en vind het nu aantrekkelijk om positie weer op te bouwen.

    AsiDNA™ is the first compound generated from platON™ en dit oncologie programma zal het op korte termijn moeten bewijzen in studie met max. 36 patiënten waarbij vaste tumoren zijn vastgesteld.

    Het komt er nu op aan. Marktwaarde Onxeo €50 miljoen en geldmiddelen t/m ... 2020.

    Een zeer aantrekkelijke markt ligt open voor AsiDNA programma en dit willen ze ook breed toepassen.

    Onxeo is developing AsiDNA™, a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a unique decoy & agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. AsiDNA™ is currently being evaluated for systemic (IV) administration in advanced solid tumors in the DRIIV-1 phase I study (DNA Repair Inhibitor administered IntraVenously).

    Persbericht van gisteren is heel belangrijk.
    Daarbij heb ik veel vertrouwen in Françoise Bono als Directeur scientifique Onxeo.

    www.linkedin.com/in/fran%C3%A7oise-bo...

  4. Bioteg71 19 oktober 2018 10:39
    quote:

    pe26 schreef op 19 oktober 2018 10:26:

    Dank sp1946 voor al je Onxeo bijdragen.

    Gisteren en vandaag aandelen Onxeo gekocht.
    Mijn portefeuille beslaat voor 85% uit Galapagos LT.

    Volg Onxeo al langer en vind het nu aantrekkelijk om positie weer op te bouwen.

    AsiDNA™ is the first compound generated from platON™ en dit oncologie programma zal het op korte termijn moeten bewijzen in studie met max. 36 patiënten waarbij vaste tumoren zijn vastgesteld.

    Het komt er nu op aan. Marktwaarde Onxeo €50 miljoen en geldmiddelen t/m ... 2020.

    Een zeer aantrekkelijke markt ligt open voor AsiDNA programma en dit willen ze ook breed toepassen.

    Onxeo is developing AsiDNA™, a first-in-class, highly differentiated DNA Damage Response (DDR) inhibitor based on a unique decoy & agonist mechanism acting upstream of multiple DDR pathways. Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors. AsiDNA™ is currently being evaluated for systemic (IV) administration in advanced solid tumors in the DRIIV-1 phase I study (DNA Repair Inhibitor administered IntraVenously).

    Persbericht van gisteren is heel belangrijk.
    Daarbij heb ik veel vertrouwen in Françoise Bono als Directeur scientifique Onxeo.

    www.linkedin.com/in/fran%C3%A7oise-bo...

    Hoi Pe26,

    Ik had ze ook al langer op de radar staan en nu jij ingestapt bent heb ik ook een pluk gekocht. We gaan het zien.
  5. sp1946 19 oktober 2018 10:49
    Als je niets te vertellen hebt ga je daar niet tussen zitten

    14.00 AsiDNA, A First-in-Class Decoy Oligonucleotide Targeting DNA Repair to Kill Tumor Cells
    Françoise Bono
    Chief Scientific Officer
    Onxeo

    Maulik Patel
    Senior Clinical Scientist
    AbbVie

    J. Carl Barrett
    Vice President of Translational Science in Oncology
    AstraZeneca

    Geoffrey Shapiro
    Director, Early Drug Development Center
    Dana Farber Cancer Institute

    Alan D’Andrea
    Professor of Radiation Oncology
    Harvard Medical School

    Lee Zou
    Professor Pathology
    Harvard Medical School

    Joo Sang lee
    Research Fellow Cancer Data Science Lab National Cancer Institute
    National Institute of Health

    Ross Stewart
    Director, Early Development & Translational Oncology
    Pfizer

    Jianfang Ning
    Assistant Professor, Neurosurgery
    University of Minnesota Medical Schoo

  6. [verwijderd] 19 oktober 2018 16:58
    quote:

    sp1946 schreef op 19 oktober 2018 10:49:

    Als je niets te vertellen hebt ga je daar niet tussen zitten

    14.00 AsiDNA, A First-in-Class Decoy Oligonucleotide Targeting DNA Repair to Kill Tumor Cells
    Françoise Bono
    Chief Scientific Officer
    Onxeo

    Maulik Patel
    Senior Clinical Scientist
    AbbVie

    J. Carl Barrett
    Vice President of Translational Science in Oncology
    AstraZeneca

    Geoffrey Shapiro
    Director, Early Drug Development Center
    Dana Farber Cancer Institute

    Alan D’Andrea
    Professor of Radiation Oncology
    Harvard Medical School

    Lee Zou
    Professor Pathology
    Harvard Medical School

    Joo Sang lee
    Research Fellow Cancer Data Science Lab National Cancer Institute
    National Institute of Health

    Ross Stewart
    Director, Early Development & Translational Oncology
    Pfizer

    Jianfang Ning
    Assistant Professor, Neurosurgery
    University of Minnesota Medical Schoo

    Mooi gezelschap met Big pharma, zoals: Pfizer, AbbVie en AstraZeneca.

    Françoise Bono, Chief Scientific Officer (CSO) of Onxeo, said: “We are pleased to have been selected to present at this benchmark event among the world’s most recognized stakeholders in DNA Damage Response. This is the ideal forum to update the industry, scientific and clinical experts on the recent clinical development progress achieved with AsiDNA™, a highly-differentiated molecule acting upstream of multiple DNA damage response pathways.”

    Mogelijk is CSO Onxeo Françoise Bono al op de hoogte van preliminary data (?).
    Dan is het uitstekend om eind januari 2019 de vorderingen te presenteren.

    Clinical development of Onxeo’s lead product candidate AsiDNA™ progressing to plan:

    > Preliminary safety and activity results of DRIIV-1 study are expected in Q4 2018 > confirm AsiDNA™ IV infusion safety, PK and bioactivity in man

    clinicaltrials.gov/ct2/show/NCT035796...

    Na mindere vorderingen van de andere projecten (Livatag) kan AsiDNA™ zeer veelbelovend zijn voor toekomst Onxeo en haar platform. Bij succes DRIIV-1 studie zijn er partneringsmogelijkheden voor versnellen van toekomstige AsiDNA™ studies.
  7. [verwijderd] 21 oktober 2018 21:04
    Onxeo en haar programma AsiDNA™ vraagt om verdere verdieping PARP-inhibitors:

    "Translational research has highlighted the unique properties of AsiDNA™, notably its ability to oppose and even reverse tumor resistance to PARP inhibitors regardless of the genetic mutation status, and its strong synergy with other tumor DNA-damaging agents such as chemotherapy and PARP inhibitors."

    5 PARP-inhibitors uitgelicht:

    1) AstraZeneca’s olaparib is goedgekeurd als medicijn sedert 2014 en genaamd LYNPARZA. Voor terugkerende eierstokkanker (2014) en specifiek type borstkanker (2018).

    2) Pfizer’s talazoparib » goedgekeurd als medicijn voor specifiek type borstkanker sedert 2018.

    3) AbbVie’s veliparib heeft in meerdere fase 2 en 3 sudies niet voldoende werking gegeven.

    4) Tesaro’s niraparib goedgekeurd in (2017)

    5) Clovis Oncology’s rucaparibgoedgekeurd in (2016)

    www.investagainstcancer.com/can-we-co...

    www.prnewswire.com/news-releases/parp...

    www.astrazeneca.com/media-centre/pres...

    "Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells."

    De meeting van 30-1-2019 waar Onxeo ia vertegenwoordigd met AstraZeneca, Pfizer en AbbVie e.d. is zeer betekenisvol.

    Zeker AstraZeneca is voorloper op DNA-repair moleculen.

    Onxeo zal moeten aantonen hoe goed AsiDNA™ technologie is. Cruciale maanden op komst.
  8. sp1946 25 oktober 2018 18:59
    Onxeo Reports Third Quarter Financial Information and Provides Business Update

    AsiDNA™ clinical development progressing to plan ? First safety and activity results of the phase I DRIIV-1 study expected in Q4 2018 ? Phase Ib/IIa combination studies of AsiDNA™ to be initiated as early as H1 2019 New first-in-class compound from PlatON™, expected before end 2018, will enter preclinical testing in 2019 Cash position of €13 million at September 30, 2018, supports the Company’s development in the attractive field of DNA Damage Response into 2020

    Paris, October 25, 2018 – 6:30 pm CEST - Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a clinical-stage biotechnology company specializing in the development of innovative drugs in oncology targeting tumor DNA Damage Response (DDR) to fight resistant cancers, today reported its consolidated revenues and cash position at September 30, 2018, and provided a business update.
    Judith Greciet, Chief Executive Officer of Onxeo, said: “The development of AsiDNA™, our strongly differentiated lead product in the compelling field of DNA Damage Response (DDR), has considerably accelerated in the third quarter of 2018, especially on the clinical side with the DRIIV -1 study running at full speed. Given the favorable recruitment pace, we are on track to publish the preliminary activity results before the end of this year. These activity data will be of paramount importance as they should confirm that AsiDNA™ enters tumoral cells and engages with its biological targets. This demonstration that AsiDNA™ is active in man via intravenous administration will represent a significant catalyst in the value of this product. This will open the way to the initiation of phase Ib/IIa combination studies to confirm the interest of combining AsiDNA™ with PARP inhibitors or other tumor-DNA damaging agent, and Onxeo plans to start a first combination study as soon as H1 2019. The optimization of new leads from PlatON™ is also moving forward. We maintain our objective to announce a new drug candidate, with different targets from those of AsiDNA™, by the end of 2018 in order to proceed with preclinical tests in 2019. ”

    Q3 2018 financial information
    Revenues for the third quarter of 2018 reached €3.3 million and consisted of: • €0.6 million in recurring revenues, in line with 2017 figure, corresponding to product sales from the European named patient program (NPP) and royalties on sales of partner Spectrum Pharmaceuticals. The latter has no cash impact as a result of the royalty monetization implemented in June 2018 with SWK Holdings Corporation.

    • €2.7 million in non-recurring revenues mostly including milestone payments from licensing agreements on historical products divested to Vectans Pharma in July 2017. Indeed, Onxeo has retained the right to most milestones payments attached to the products sold to Vectans.

    PRESS RELEASE

    2 / 3
    At September 30, 2018, the Company had a consolidated cash position of €13 million compared with €11 million at June 30, 2018. This cash position includes €2.4 million in gross proceeds from drawdowns of the equity line implemented on June 15, 2018, with Nice & Green SA. Provided full utilization of this financing reserve, cash runway will extend into 2020, allowing the Company to reach planned short-term value-creating milestones resulting from current preclinical and clinical programs.
    9-month 2018 corporate highlights, recent events & outlook • AsiDNA™ - New ‘composition of matter’ patent granted in January 2018 providing European protection until 2031 with a potential extension to 2036. Together with previously granted patents, Onxeo’s DNA-targeting technologies, products and combinations are now protected by 10 patent families worldwide. - Additional preclinical results of AsiDNA™ in combination with PARP inhibitors (PARPi), published in July 2018, demonstrated a strong synergistic effect and a reversion of tumor resistance. - The DRIIV-1 study of AsiDNA™, conducted at leading oncology centers in France and Belgium since April 2018, is progressing according to plan. The favorable pace of recruitment confirms the Company’s expectations of publishing preliminary activity results in Q4 2018 and completing the study in Q1 2019. The positive preclinical data of AsiDNA™ in combination with PARPi, together with the expected activity results of the DRIIV-1 study, will support the initiation of phase Ib/IIa studies of AsiDNA™ in combination in H1 2019. • platON™ - Onxeo’s proprietary chemistry platform enables the Company to generate additional innovative drug candidates with the common feature of targeting tumor DNA functions through a decoy mechanism. - Onxeo has made significant progress in the optimization of a new compound and expects to announce, by the end of the year, a new first-in-class drug candidate, targeting different tumor cell DNA-binding functions than AsiDNA™. - The Company intends to initiate preclinical studies and CMC activities for this new compound in 2019. • Beleodaq® - Onxeo1 and Spectrum Pharmaceuticals received a Paragraph IV Notice Letter stating that Fresenius Kabi USA, LLC has submitted to the FDA an Abbreviated New Drug Application seeking approval from the FDA to manufacture and market a generic version of Beleodaq® (belinostat) for injection, 500 mg, in the United States. - Onxeo and Spectrum jointly filed a patent infringement lawsuit2 against Fresenius which triggered a stay of FDA approval of Fresenius’ ANDA that expires on January 3, 2022. Onxeo and Spectrum have confidence in the validity of the patents covering Beleodaq® in the US. In addition, Beleodaq® is protected from competition in the United States by Orphan Drug Exclusivity until July 3, 2021.
    UPCOMING EVENTS • BIO-Europe: November 5-7, 2018, Copenhagen (Denmark) • Boursocap / Les Echos – Investir Event: November 21, 2018, Paris (France) • Investor meetings during the JP Morgan Healthcare Conference 2019: January 7-10, 2019, San Francisco (US) • BioMed Event: January 22, 2019, Paris (France)
  9. [verwijderd] 25 oktober 2018 21:58
    Prima update.

    DRIIV-1 studie verloopt volgens planning met voorlopige data in Q4 2018.

    Quote:
    Judith Greciet, Chief Executive Officer of Onxeo, said: “The development of AsiDNA™, our strongly differentiated lead product in the compelling field of DNA Damage Response (DDR), has considerably accelerated in the third quarter of 2018, especially on the clinical side with the DRIIV -1 study running at full speed. Given the favorable recruitment pace, we are on track to publish the preliminary activity results before the end of this year. These activity data will be of paramount importance as they should confirm that AsiDNA™ enters tumoral cells and engages with its biological targets. This demonstration that AsiDNA™ is active in man via intravenous administration will represent a significant catalyst in the value of this product.
  10. forum rang 4 RW1963 27 oktober 2018 18:14
    quote:

    sp1946 schreef op 26 oktober 2018 14:18:

    Deze reactie kan niet waar op dit mooie en spannende bericht. Verdere berichten zijn in aantocht. Daar past geen koersje van nog geen € 0,90 bij.
    Welk(e) koers(je) past daar volgens jou wel bij dan?
    Ooit aandelen Onxeo aandelen verkocht met verlies.
    Heb nog wel een deel gehouden, maar deze moeten eerst weer flink stijgen om eerst dat verlies weer goed te maken.
  11. sp1946 28 oktober 2018 11:50
    Koersvoorspellingen, daar waag ik mij niet aan. Beleggers zijn teleurgesteld geweest in de ontwikkelingen van Livatag en ook in de verloren rechtszaak tegen SpeBio { € 8,6 mln. } en hebben daarna het aandeel de rug toegekeerd. Maar de ontwikkelingen zijn doorgegaan.

    De uitspraken zijn duidelijk o.a.: “”allowing the Company to reach planned short-term value-creating milestones resulting from current preclinical and clinical programs”” en “”The development of AsiDNA™, our strongly differentiated lead product in the compelling field of DNA Damage Response (DDR), has considerably accelerated in the third quarter of 2018, especially on the clinical side with the DRIIV -1 study running at full speed. Given the favorable recruitment pace, we are on track to publish the preliminary activity results before the end of this year. These activity data will be of paramount importance as they should confirm that AsiDNA™ enters tumoral cells and engages with its biological targets””.

    Dit jaar nog de uitslag van: AsiDNA™ clinical development progressing to plan First safety and activity results of the phase I DRIIV-1 study expected in Q4 2018.

    M.i. wordt januari 2019 de belangrijkste periode:
    Session: New Developments in PARP Inhibitors & Novel DDR Pathway Targets
    Date: Wednesday, January 30, 2019
    UPCOMING EVENTS •
    BIO-Europe: November 5-7, 2018, Copenhagen (Denmark) •
    Boursocap / Les Echos – Investir Event: November 21, 2018, Paris (France) •
    Investor meetings during the JP Morgan Healthcare Conference 2019: January 7-10, 2019, San Francisco (US) •
    BioMed Event: January 22, 2019, Paris (France)

    En dan toch even de koers. Ruim een jaar geleden schommelde die rond de € 1,- met een rally in januari 2018 naar € 2,30 in een paar weken tijd. Daarna in een constant dalende trend tot het huidige niveau. Zet daarnaast de huidige positieve ontwikkelingen die volledig in strijd zijn met de koersontwikkeling dan zal daar op een gegeven moment een aanpassing moeten komen. Op dit moment is het algemene beursklimaat ook niet al te best. Koersen van boven de € 10 zoals die in 2014 voorkwamen lijken op dit moment nog een utopie. Maar ik heb met mijn Amerikaanse biobeleggingen wel gekkere dingen meegemaakt. Misschien ken jij het Nederlandse bedrijf Uniqure die voordien als AMT aan de Nederlandse beurs verhandeld werd en met een paar dubbeltjes als koers na een splitdown van 1 op 5 naar de Amerikaanse beurs verhuisde. Koers is gestegen tot boven de 43 dollar, recent 26. Kijk even naar Synergy {SGYP} die afgelopen vrijdag bijna 70% daalde met analistenadviezen die hun weerga niet kennen. Maar elke belegging kent risico's. Ik wens je wijsheid toe.

  12. forum rang 4 RW1963 28 oktober 2018 18:01
    quote:

    sp1946 schreef op 28 oktober 2018 11:50:

    Misschien ken jij het Nederlandse bedrijf Uniqure die voordien als AMT aan de Nederlandse beurs verhandeld werd en met een paar dubbeltjes als koers na een splitdown van 1 op 5 naar de Amerikaanse beurs verhuisde. Koers is gestegen tot boven de 43 dollar, recent 26.
    .................
    .................
    Ik wens je wijsheid toe.
    Ook met Uniqure heb ik slechte ervaringen. Te hoog gekocht. Na flinke tegenvallers te vroeg verkocht. Tja, achteraf is het altijd gemakkelijk.
    ....
    ....
    Voor de eerste Onxeo's betaalde ik € 3,97. Na een korte opleving midden 2017 is het toen in september bijna gehalveerd en de klap nooit meer te boven gekomen. Maar gaat het dan nu alsnog gebeuren?
    Bedankt. Jij ook veel succes en dat Onxeo ons nog veel mag opleveren :-)
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