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MOR103 (PerC6 inside) PHASE I
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Tsjongejonge, wat een prachtig jaarrapport. Zo volledig en open. Dat kunnen die Duitsers toch wel!
PSmink schreef:
Tsjongejonge, wat een prachtig jaarrapport. Zo volledig en open. Dat kunnen die Duitsers toch wel!
Het is ook het land met de meest complexe belastingwetgeving ter wereld.
Webcast vandaag op Morphosys.com Sterke focus op antibodies met name op human cells. Uitbreiding eigen programma's > mogelijk additionele licenties voor Crucell. Grootste deel eigen investeringen op MOR103, wat minder op MOR202 en verder opstart nieuwe eigen ontwikkeling programma. Met huidige prognose (+10 a 20 % omzetgroei in 2009 en hele grote groei in 2011 en verder) geen rekening gehouden met effecten van Obama plannen. Van Obama wordt verwacht dat meer geld naar research gaat en met name naar de NIH > meer geld voor programma die NIH financiert > goed voor Morphosys (maar dus ook voor Crucell). Bruto marge ongeveer 60%. Goede presentatie. Prima vragen. Gespreid aandelenbezit. Met name extra belangstelling uit US (willen niet te laat instappen). Richt zich op ontwikkeling targets tot proof of cncept waarna een partner erbij. Novartis heeft7% en levert veel omzet. Omzet vrij zeker door gesloten contracten. EUR 137 miljoen cash eidn 2008 + winstgevend. Geen fiscale verliezen maar gewoon ongeveer 30% belasting (in 2008 en volgende jaren). Winst pa 2008 EUR 0.59 In 2009 door vedubbeling research uitgaven wel winst maar mogelijk wat lager. Hangt een beetje af van tempo uitvoering ontwikkeling Mor103 en andere projecten + milestones van projecten van partners. Geen verkeerde aankoop denk ik, maar gaat pas echt lopen denk ik als in 2e kwartaal Mor103 fase 1 resultaten worden gepubliceerd.
MorphoSys Strengthens Patent Position on its Core HuCAL Technology in Europe 03/13/2009 at 07:30 AM MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that the European Patent Office has granted a European divisional patent stemming from MorphoSys's base HuCAL (Human Combinatorial Antibody Library) patent family, providing extended protection for the Company's core technology. The new patent (EP1143006) captures HuCAL's modular design at the DNA level, providing solid product claim protection in Europe. MorphoSys's HuCAL libraries comprise highly diverse, fully human synthetic antibodies that are highly engineerable through their modular CDR design. Its most advanced marketed version, HuCAL PLATINUM, provides rapid access to fully human antibodies as research tools, diagnostics and therapeutics. A first European HuCAL patent, which is now complemented by the new patent, was issued by the European Patent Office in 2002. HuCAL patents have been granted in the United States, Australia and at the European Patent Office. In total, the Company is prosecuting about thirty different proprietary patent families worldwide, which comes in addition to approximately thirty patent families the Company is pursuing in cooperation with its partners. "This new patent is a further example of the pioneering nature of our proprietary core technology, HuCAL, and provides us with another solid layer of protection in Europe. We will carry on with this process, continuing to build a strong intellectual property portfolio around HuCAL and our other antibody-related technologies," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.www.morphosys.com/en/news_investors/p...
MorphoSys AG Reports Strong Results for First Quarter 2009 The Company’s most advanced compound MOR103 is expected to enter a phase 1b/2a clinical trial in the second half of 2009. MOR103 The phase 1 clinical trial for MOR103 in healthy volunteers has been completed and is currently in the analysis stage. The final data will be reported in Q2 2009. Additional preclinical investigations of MOR103 in animal models for other inflammatory diseases are currently being conducted. MOR202 The preclinical development and manufacturing of MOR202 continues as planned. Start of clinical development is expected in 2010.212.14.81.205/uploads/MOR_Q1-2009_e_f...
MorphoSys Achieves Clinical Milestone and Payment in Antibody Alliance 05/05/2009 at 07:30 AM MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it has received a milestone payment from its collaboration with Novartis. The payment was triggered by Novartis filing of the necessary documentation to initiate a Phase 1 clinical trial with a HuCAL-derived fully human antibody. This is the second HuCAL antibody to enter clinical trials within MorphoSys's alliance with Novartis. "Our partnered pipeline is a core asset that is a key driver of the Company's value," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Our alliance with Novartis is developing well and we are delighted to see this second program advance into Phase 1 clinical trials. These two programs in the clinic illustrate the progress we've made, but are only the tip of the iceberg in terms of the value that the Novartis alliance brings to MorphoSys." In December 2007, MorphoSys and Novartis forged one of the industry's most comprehensive strategic alliances in the discovery and development of biopharmaceuticals. Financial terms include committed payments in excess of US$600 million over the lifetime of the agreement. This is the sixth HuCAL-based antibody to advance into clinical development. MorphoSys anticipates that in 2009, between two and four partnered programs will enter clinical trials. With regard to its proprietary pipeline, the Company expects to commence a Phase 1b/2a trial of its proprietary program MOR103 in the second half of this year. By the end of 2009 the Company expects its partnered and proprietary pipeline to comprise up to eight compounds in clinical trials, thereof at least three antibodies in phase 2 studies.www.morphosys.com/en/news_investors/p...
Daiichi Sankyo and MorphoSys Expand Collaboration with two new Cancer-Related Antibody Programs 05/18/2009 at 07:30 AM MorphoSys AG (Frankfurt Stock Exchange: MOR; Prime Standard Segment, TecDAX) announced today the start of a further two oncology-focused therapeutic antibody programs within its collaboration with DAIICHI SANKYO COMPANY, LIMITED (TSE: 4568, hereinafter Daiichi Sankyo). By exercising two options available under the parties' existing agreement, Daiichi Sankyo has selected two new target molecules against which MorphoSys will generate antibodies using its proprietary HuCAL technology. Daiichi Sankyo will carry out pre-clinical and clinical development and has worldwide marketing rights for all resulting products. MorphoSys receives exclusive license fees and stands to receive milestones and royalties for the therapeutic antibody programs, as per the terms of the companies' existing agreement. Further financial details were not disclosed. "The addition of these new oncology programs promises to strengthen still further our partnered antibody pipeline", commented Dr. Simon Moroney, CEO of MorphoSys. "We look forward to working with Daiichi Sankyo on the programs, and making progress towards our declared goal of establishing a broad therapeutic pipeline of HuCAL-based antibody drugs." The two companies have been engaged in joint application of MorphoSys's advanced phage display and human antibody library technologies since March 2006. In March 2008, Daiichi Sankyo exercised its option to extend the contracting period until March 2011. Today, the collaboration encompasses four active therapeutic antibody programs. In May 2008, Daiichi Sankyo further strengthened its pipeline of novel targeted therapeutics in oncology by acquiring the German biotechnology company U3 Pharma AG. The cancer-related target molecules, which build the basis for the HuCAL-based programs, were part of U3 Pharma's portfolio.www.morphosys.com/en/news_investors/p...
June 9, 2009 BioEquity, Munich, Germany MOR103Proprietary Inflammation Program HuCAL IgG1 antibody targeting GM-CSF Primary indication: Rheumatoid arthritisPotential in asthma, COPD, multiple sclerosis… Clinical DevelopmentPh 1: 7 cohorts @ 9 volunteers in a randomized, double-blind, placebo-controlled, single-ascending dose trial Safety, tolerability, pharmacokinetics Q2 2009: Report Ph 1 results H2 2009: File for Ph 1b/2a trial MOR103 AdvantagesFemtomolaraffinity: potential CoGSadvantage Strong IP PositionExclusive license to US patent covering inhibitors of GM-CSF in inflammatory conditions Patent applications on the MOR103 antibody family Nearing clinical proof of concept MorphoSys MOR103 RAwww.morphosys.com/uploads/090609_MOR_... Uit de post van sammie: Morphosys , alle antibodies op PerC6, In Europa , 1 is filing for approval.www.iex.nl/forum/topic.asp?forum=228&...
Uit April: MOR103 IP and Outlook 2009 Outlook 2009: Final results from phase 1 in healthy volunteers in Q2/2009 Start of phase 1b/2a study in RA patients in H2 2009 Decision on second indication, based on efficacy in disease models in © MorphoSys AG 2009 MOR202 Proprietary Cancer Program MOR202, a fully human HuCAL antibody, targeting CD38, a 45 kDa ectoenzyme heavily over-expressed in 95% of MM celllines and some leukemia lines Function: Induces cell-killing by ADCC, CDC & apoptosis Primary indication: Multiple myeloma (MM) Commercial opportunity 10 % of hematological cancers / 1% of all cancers / 2% of cancer deaths No curative therapies Median survival 24 – 30 months, all patients eventually relapse Outlook 2009: Further evaluation in animal models of multiple myeloma Start of non-clinical safety study to support clinical testing Start of preclinical efficacy studies in second indication Production and release of mAb material for animal safety testing © MorphoSys AG and in preparation for phase 1/2a clinical testing in 2010www.morphosys.com/uploads/090428_MOR_...
MorphoSys Announces Extension of Antibody Alliance with Schering-Plough 06/16/2009 at 07:30 AM MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Schering-Plough Corporation has triggered its pre-existing option to extend the current collaboration between the two companies for another year. The partnership, which was initiated in May 2006, may be extended by Schering-Plough annually until 2011. The agreement grants Schering-Plough continued access to MorphoSys's proprietary antibody library HuCAL GOLD at its research site, Schering-Plough Biopharma, in Palo Alto, Calif., and contains options for therapeutic licenses. For therapeutic antibody projects undertaken by Schering-Plough, MorphoSys is eligible to receive license fees, plus milestone payments relating to the successful advancement of projects in clinical development, and royalties on HuCAL antibodies developed under the agreement. Under the extended agreement, MorphoSys continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed. "We are pleased with Schering-Plough's decision to extend the current collaboration," comments Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "Today's news demonstrates once more the continued commitment of leading pharmaceutical companies worldwide to our HuCAL technology for their antibody-based drug development programs."www.morphosys.com/en/news_investors/p... ************ @callhans: www.youtube.com/watch?v=vd_oMdLlnZo lol.
Graag gedaan! Zijn wel "Hollandse" zo.
MorphoSys Strengthens Patent Position on its Core Technologies in Japan 06/18/2009 at 07:30 AM First Granted HuCAL-Related Patent in Japan MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that the Japanese Patent Office has granted a new patent covering its CysDisplay® technology. CysDisplay® is a proprietary screening technology, which is an important component of MorphoSys's proprietary HuCAL platform. The new patent (JP 4312403) entitled "Novel Methods for Displaying (Poly)Peptides/Proteins on Bacteriophage Particles" describes a selection technology based on phage display for selecting high affinity antibodies. The claims are not limited to the use of a HuCAL library with this selection technology. Additional applications, including continuation applications, are currently pending in different countries. "This new patent expands the protection of our proprietary core technology HuCAL in Asia. Over the last few years we have built a strong intellectual property portfolio around our proprietary technology HuCAL, which lies at the heart of our successful partnership-based business model. We expect to continue to strengthen still further our IP position in this important market for antibody-based products and services," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. MorphoSys's HuCAL libraries are collections of highly diverse, fully human synthetic antibodies, whose modular CDR designs facilitate systematic engineering of antibody properties. The company's most advanced marketed version, HuCAL PLATINUM, provides rapid access to fully human antibodies as research tools, diagnostics and therapeutics. HuCAL patents have been granted in the United States, Australia, and at the European Patent Office. In total, the Company is prosecuting about thirty different proprietary patent families worldwide, which comes in addition to approximately thirty patent families the Company is pursuing in cooperation with its partners.www.morphosys.com/en/news_investors/p...
MorphoSys beantragt Phase 1b/2a-Studie für sein Leitprogramm MOR103 zur Behandlung der Rheumatoiden Arthritis 24.06.2009 / 07.30 Uhr Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute bekannt, dass sie einen Antrag für die Durchführung einer klinischen Studie der Phase 1b/2a an Patienten mit aktiver Rheumatoider Arthritis (RA) für den am weitesten fortgeschrittenen firmeneigenen Medikamenten-Kandidaten MOR103 eingereicht hat. Bei MOR103 handelt es sich um einen vollständig menschlichen HuCAL-basierten therapeutischen Antikörper, der gegen das krankheitsrelevante Zielmolekül GM-CSF (Granulozyten-Makrophagen-Kolonie-stimulierender Faktor) gerichtet ist. Die Studie, die in mehreren klinischen Zentren in verschiedenen europäischen Ländern durchgeführt werden soll, wird voraussichtlich insgesamt rund 135 Patienten einschließen und in der zweiten Jahreshälfte 2009 beginnen. Zusätzlich berichtete das Unternehmen heute positive Ergebnisse der mit gesunden Probanden abgeschlossenen klinischen Phase-1-Studie zu MOR103. Die Ergebnisse der Studie lassen darauf schließen, dass MOR103 bei allen verabreichten Dosen als generell sicher und gut verträglich gelten kann. "Wir sind sehr erfreut, die klinische Entwicklung unseres viel versprechenden Wirkstoffs MOR103 in einer Studie der Phase 1b/2a fortsetzen zu können, um die Sicherheit und Verträglichkeit weiter zu evaluieren sowie klinische Aktivität in RA-Patienten demonstrieren zu können", kommentiert Dr. Arndt Schottelius, Entwicklungsvorstand der MorphoSys AG. "In Verbindung mit den attraktiven präklinischen Daten unterstützen die Ergebnisse, die wir in der Phase-1-Studie gewonnen haben, unserer Pläne, mit MOR103 eine sichere und wirksame Behandlungsoption für entzündliche Erkrankungen zu entwickeln. Neben den außergewöhnlichen Eigenschaften, die unser Antikörper in Hinblick auf Bindungsstärke, Spezifität und Stabilität gezeigt hat, konnten wir nun zusätzlich eine robuste Halbwertszeit im humanen Serum belegen." Die abgeschlossene Phase-1-Studie war als eine randomisierte, placebo-kontrollierte, doppelt-verblindet durchgeführte Studie mit einer von Probandengruppe zu Probandengruppe steigenden Dosis des Antikörpers MOR103 angelegt. Das Ziel der Studie war es, die Sicherheit und Verträglichkeit sowie die Pharmakokinetik von MOR103 in gesunden Probanden zu untersuchen. Insgesamt erhielten 63 Probanden in sieben Dosisgruppen den Wirkstoff MOR103 in ansteigenden Konzentrationen bis zu 3 mg/kg oder ein Placebo intravenös verabreicht. Eine maximal tolerierte Dosis (MTD) wurde nicht erreicht. Die Betrachtung der pharmakokinetischen Eigenschaften des Wirkstoffs MOR103 ergab eine für vollständig menschliche Antikörper typische Halbwertszeit im Serum, die ein wettbewerbsfähiges Dosierungsschema ermöglichen könnte. Die insgesamt gezeigten Eigenschaften von MOR103 in Bezug auf Sicherheit, Verträglichkeit und Pharmakokinetik bieten eine solide Ausgangsbasis für die Entwicklungspläne des Unternehmens inklusive der bevorstehenden Phase 1b/2a-Studie in Patienten. MorphoSys' Vorstandsvorsitzender Dr. Simon Moroney präsentiert heute auf der 4. Annual Piper Jaffray Europe Conference um 09:30 MESZ. Die Präsentationsfolien sowie ein Webcast der Präsentation werden auf der Unternehmenswebseite www.morphosys.de bereit gestellt.www.morphosys.com/de/presse_investore...
Mooi go, prima berichtgeving vandaag ik ga me wat vaker verslapen.... Eng. versie: MorphoSys Reports Filing for Phase 1b/2a Trial for its Lead Program MOR103 in Rheumatoid Arthritis 06/24/2009 at 07:30 AM MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that the Company has submitted an application for the authorization of a phase 1b/2a clinical study in patients with active rheumatoid arthritis (RA) for its lead drug MOR103, a fully human HuCAL-derived monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor. The trial, which will be conducted in multiple centers in several European countries, is expected to enroll 135 patients in total beginning in the second half of 2009. Additionally, the Company today reported positive results from the phase 1 clinical study for MOR103 in healthy volunteers. The results of this study indicate that MOR103 is generally safe and well tolerated at all doses administered. "We are pleased to advance the clinical development of this promising compound into a phase 1b/2a clinical trial to further evaluate safety and tolerability as well as clinical activity in RA patients," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys. "In combination with the attractive preclinical profile the results we have seen in the phase 1 trial support our plans to develop MOR103 as a safe and efficacious drug for the treatment of inflammatory disorders. In addition to the excellent characteristics the antibody has shown so far with regard to affinity, specificity and stability, we have been able to demonstrate a robust serum half-life in humans." The completed phase 1 trial was designed as a randomized, double-blind, placebo controlled single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of MOR103 in healthy volunteers. In total, 63 volunteers received ascending doses of MOR103 up to a concentration of 3 mg/kg or placebo in seven dose cohorts via intravenous infusion. No maximum tolerated dose (MTD) was reached in the study. Analysis of the pharmacokinetic properties of MOR103 showed a serum half-life typical of a fully human antibody which could translate into a competitive dosing regimen. The overall safety, tolerability and pharmacokinetic properties of MOR103 provide a solid foundation for the Company's development plans, including the forthcoming Phase 1b/2a study in patients.www.morphosys.com/en/news_investors/p...
Piper Jaffray Europe Conference June 24, 2009 MOR103 Phase I Study PrimaryObjectives:Safety&Tolerability Single i.v. infusion at doses ranging up to 3 mg/kg were generally safe and well tolerated SecondaryObjectives:PKandImmunogenicity Pharmacokinetics were generally consistent between subjects and throughout the dose range studied No anti-MOR103 IgGantibodies were observed in doses up to 3 mg/kg Changes in general IgA, IgG, and IgMconcentrations, if any, were similar in all groups, including the placebo PhaseIb/IIaTrialDesign More than 130 Rheumatoid Arthritis patients Multiple centers in several European countries to ensure robust patient recruitment212.14.81.205/uploads/090624_MOR_Pipe... Deutsche Bank German & Austrian Corporate Conference Frankfurt – June 23, 2009 MOR103 Proprietary Inflammation Program MOR103, a fully human HuCAL antibody targeting GM-CSF GM-CSF plays a central role in inflammation and auto-immunity MOR103 blocks binding of GM-CSF to its receptor with sub-pM affinity Primary indication: Rheumatoid arthritis Commercial opportunity: Anti-TNF therapies Enbrel, Remicade, Humira are successful biologic products for treating RA, but still under 25% of RA patients are adequately treated Promising scientific and preclinical data Successful completion of phase 1 in healthy volunteers (favorable safety profile after 5 cohorts led to trial-extension; in total, 7 cohorts with 9 volunteers each, were treated) Data support development of GM-CSF mAb therapy in different inflammatory diseases (rheumatoid arthritis, multiple sclerosis) and lung diseases (COPD, asthma) MOR103 IP and Outlook 2009 Broad patent protection for MOR103 in the US, the largest RA market: ANTIBODY Patent applications covering key features of the MOR103 program Exclusive License US patent covering key uses of antibodies against GM-CSF WO 2006122797 U.S. 7,455,836 Final results from phase 1 in healthy volunteers in Q2/2009 Start of phase 1b/2a study in RA patients in H2 2009 Decision on second indication, based on efficacy in disease models in 2009 MOR202 Proprietary Cancer Program MOR202, a fully human HuCAL antibody, targeting CD38, a 45 kDa ectoenzyme heavily over-expressed in 95% of MM cell-lines and some leukemia lines Function: Induces cell-killing by ADCC, CDC & apoptosis Primary indication: Multiple myeloma (MM) Commercial opportunity 10 % of hematological cancers / 1% of all cancers / 2% of cancer deaths No curative therapies Median survival 24 – 30 months, all patients eventually relapse Outlook 2009: Further evaluation in animal models of multiple myeloma Start of non-clinical safety study to support clinical testing Start of preclinical efficacy studies in second indication Production and release of mAb material for animal safety testing and in preparation for phase 1/2a clinical testing in 2010 212.14.81.205/uploads/090623_MOR_GACC...
MorphoSys gibt klinischen Meilenstein in therapeutischem Antikörperprogramm bekannt 29.06.2009 / 07.30 Uhr Seventh HuCAL Antibody to Enter Clinical Trials Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute das Erreichen eines klinischen Meilensteins und den Erhalt einer entsprechenden Meilensteinzahlung von seinem Partner Centocor Ortho Biotech Inc. (ehemals: Centocor, Inc.) bekannt. Ausgelöst wurde die Meilensteinzahlung durch einen Antrag zum Beginn einer klinischen Phase-1-Studie mit einem vollständig menschlichen HuCAL-basierten Antikörper zur Behandlung von Entzündungskrankheiten durch Centocor Ortho Biotech. "Der Eintritt eines neuen HuCAL-Antikörpers in die klinische Entwicklung bedeutet ein weiteres entscheidendes Ereignis für MorphoSys", erklärt Dr. Simon Moroney, Vorstandsvorsitzender der MorphoSys AG. "Die durch unsere Partner erzielten Fortschritte in der Entwicklung innovativer Biopharmazeutika sind ein zentraler Werttreiber für unsere Gesellschaft." Mit der heutigen Meldung erreicht bereits der zweite HuCAL-Antikörper innerhalb der Zusammenarbeit mit Centocor Ortho Biotech die Phase der klinischen Erprobung. Im Jahr 2007 hatte Centocor Ortho Biotech eine Phase-1-Studie mit einem HuCAL-Antikörper an Krebspatienten begonnen. Im Jahr 2008 folgte der Beginn einer Phase-2-Studie mit dem gleichen Antikörper in einer immunologischen Indikation. Damit wurde der erste auf der Kerntechnologie von MorphoSys basierende Antikörper von einem Kooperationspartner in klinischen Studien in zwei Krankheitsbereichen getestet. Die nun begonnene neue Studie eingeschlossen, verfolgt Centocor Ortho Biotech derzeit drei HuCAL-Antikörper in der klinischen Entwicklung. Für das Jahr 2009 erwartet MorphoSys, dass zwei bis vier Partnerprogramme die klinische Entwicklung erreichen werden. Insgesamt geht das Unternehmen davon aus, dass sich am Jahresende 2009 bis zu acht mit Partnern verfolgte sowie firmeneigene therapeutische Programme in der klinischen Entwicklung befinden könnten, darunter mindestens drei Antikörper in klinischen Phase-2-Studien.www.morphosys.com/de/presse_investore...
MorphoSys und die Universität von Melbourne beantragen neuen Patentschutz für das MOR103-Programm 02.07.2009 / 07.30 Uhr Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) und die Universität von Melbourne gaben heute eine Forschungskooperation bekannt, um neue Krankheitsbereiche für MorphoSys' firmeneigenes MOR103-Programm zu erschließen. Bei MOR103 handelt es sich um einen vollständig menschlichen HuCAL-basierten therapeutischen Antikörper, der gegen das krankheitsrelevante Zielmolekül GM-CSF (Granulozyten-Makrophagen-Kolonie-stimulierender Faktor) gerichtet ist und sich derzeit in der klinischen Entwicklung zur Therapie der Rheumatoiden Arthritis befindet. Die heute bekanntgegebene Zusammenarbeit wird sich auf die Untersuchung neuer Krankheitsprozesse fokussieren, in denen das Zielmolekül GM-CSF nach jüngsten, bislang unveröffentlichten Forschungsergebnissen der Universität von Melbourne eine Rolle einnimmt. Als Teil der hiermit erweiterten Kooperation haben beide Parteien neue Patentanmeldungen eingereicht, um die Patentposition des gegen GM-CSF gerichteten Therapieansatzes weiter auszubauen. Im Rahmen der Vereinbarung wird MorphoSys Forschungsarbeiten in mehreren neuen Indikationen an der Universität von Melbourne finanzieren. Die Universität von Melbourne erhält eine Einmalzahlung und kann weitere Forschungsmittel, entwicklungsabhängige Meilensteinzahlungen sowie Tantiemen erhalten. Weitere finanzielle Details wurden nicht bekannt gegeben. "Die Universität von Melbourne und insbesondere die Forschungsgruppe von Professor John Hamilton forschen seit langem an vorderster Front in Hinblick auf das Krankheitsmolekül GM-CSF. Wir sind sehr erfreut, die Kooperation mit MorphoSys weiter vertiefen zu können, um die Umsetzung unserer Forschungsergebnisse in klinischen Anwendungen zum Nutzen von Patienten voranzutreiben", kommentiert Dr. Charlie Day, CEO von Melbourne Ventures, der Technologietransferstelle der Universität Melbourne. "Wissenschaftler von der Universität Melbourne haben erste Anhaltspunkte gewonnen, die eine Bedeutung von GM-CSF in anderen Krankheitsbereichen als den uns bislang bekannten nahelegt", erklärt Dr. Arndt Schottelius, Entwicklungsvorstand der MorphoSys AG. "Wir werden eng zusammenarbeiten, um das Potenzial dieses Wirkmechanismus in zusätzlichen Krankheitsbereichen zu untersuchen und unsere Patentposition um Hemmstoffe gegen GM-CSF weiter auszubauen. Parallel dazu verfolgen wir die Entwicklung unseres anti-GM-CSF Antikörpers MOR103 in der Indikation Rheumatoide Arthritis wie geplant weiter." Im Jahr 2007 unterzeichnete MorphoSys eine Vereinbarung mit der Universität Melbourne, durch die sich das Unternehmen exklusiven Zugang zu einem US-Patent und deren Nachfolgern sichert, die den therapeutischen Einsatz von Hemmstoffen gegen das krankheitsrelevante Zielmolekül GM-CSF schützt. Das Patent schützt den Einsatz eines Antikörpers gegen das krankheitsrelevante Zielmolekül GM-CSF mit dem Ziel, die Auswirkungen von Entzündungsreaktionen zu lindern. Im November 2008 erteilte das US-amerikanische Patent- und Markenamt das Patent US 7,455,836, welches den Einsatz von Antikörpern gegen das krankheitsrelevante Zielmolekül GM-CSF schützt. Die Rolle des Zielmoleküls GM-CSF ist bereits in zahlreichen Krankheitsprozessen am Menschen belegt.www.morphosys.com/de/presse_investore...
MorphoSys sichert volle Vertragslaufzeit seiner umfangreichsten therapeutischen Allianz 06.07.2009 / 07.30 Uhr Die MorphoSys AG (Frankfurt: MOR, Prime Standard Segment, TecDAX) gab heute bekannt, dass ihr Partner Novartis die strategische Allianz, die im Dezember 2007 geschlossen wurde, nun verbindlich für eine Gesamtdauer von zehn Jahren zugesagt hat. Entscheidend hierfür war die erfolgreiche Umsetzung bestimmter, vorher festgelegter Fortschritte von MorphoSys' firmeneigenen Technologien. Die Zusammenarbeit wird nun bis ins Jahr 2017 bestehen bleiben und kann anschließend von Novartis zu unveränderten Konditionen um weitere zwei Jahre verlängert werden. Die Option für Novartis, die Allianz nach sieben Jahren vorzeitig zu beenden, ist damit aufgehoben. "Die heutige Nachricht erhöht nochmals den gesicherten Wert, der MorphoSys durch seine bisher größte therapeutische Partnerschaft zufließt. Unsere Allianz mit Novartis entwickelt sich bestens und wir freuen uns sehr, mit der heutigen Zusage das volle Potenzial dieser Zusammenarbeit ausschöpfen zu können", kommentierte Dr. Simon Moroney, Vorstandsvorsitzender der MorphoSys AG. "Die jüngsten technologischen Fortschritte unserer Antikörperplattform, der Kerntechnologie von MorphoSys, haben maßgeblich dazu beigetragen, dass die Kooperation jetzt vorzeitig verlängert werden konnte." Im Dezember 2007 haben die MorphoSys AG und Novartis eine der umfassendsten strategischen Allianzen der Branche zur Erforschung und Entwicklung von Biopharmazeutika geschmiedet. Die finanziellen Vereinbarungen beinhalten vertraglich zugesicherte Zahlungen an MorphoSys in Höhe von mehr als 600 Mio. US$ über den Zeitraum von zehn Jahren. Im Rahmen der Zusammenarbeit befinden sich derzeit zwei Antikörperprogramme in der klinischen Entwicklung. www.morphosys.com/de/presse_investore...
MorphoSys AG Reports Six Months 2009 Results 07/29/2009 at 07:00 AM Pipeline Expansion Continues as Planned - Financial Guidance Confirmed MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results for the first six months ended June 30, 2009 according to International Financial Reporting Standards (IFRS). Group revenues increased by 14 % to EUR 37.9 million (H1 2008: EUR 33.3 million) and operating profit amounted to EUR 6.6 million (H1 2008: EUR 8.0 million). Net profit decreased to EUR 5.0 million (H1 2008: EUR 6.3 million). The main reason for the decline in profits was, as previously announced, increased investment in proprietary drug development. At June 30, 2009 MorphoSys's cash position was EUR 144.1 million (December 31, 2008: EUR 137.9 million). Highlights of the Second Quarter of 2009: • MorphoSys reported a positive outcome to the phase 1 study of its lead compound MOR103 and submitted an application for the authorization of a phase 1b/2a clinical study in patients with rheumatoid arthritis (RA). • MorphoSys and the University of Melbourne signed an agreement to cooperate on investigating new therapeutic applications for the MOR103 program. As part of the expanded relationship, new patent applications have been filed, which are intended to broaden the scope of protection of the anti-GM-CSF approach. • MorphoSys's proprietary pipeline increased to five compounds in total. During the second quarter, work on MOR205 started as planned, and a disease-related target molecule for a new inflammation program, MOR104, was selected. Pre-clinical development of MOR202 and lead identification for MOR203 continued as planned. • Novartis committed to the full ten-year term of the strategic alliance originally signed in December 2007. The decision was based on the successful achievement by MorphoSys of certain predefined improvements in its proprietary technologies. • MorphoSys's partnered pipeline increased to 62 therapeutic antibody programs in total (compared to 55 at the beginning of the year), of which six are currently in clinical development, 31 are in preclinical development and 25 are in the discovery phase. • Two partners, namely Centocor Ortho Biotech Inc. and Novartis, commenced Phase 1 clinical trials using HuCAL-derived, fully human antibodies. • Daiichi Sankyo initiated a further two oncology-focused therapeutic antibody programs within its collaboration with MorphoSys. • Schering-Plough triggered its option to extend the current collaboration between the two companies for another year. • MorphoSys's AbD Serotec unit and Spinreact S.A. signed a supply agreement. Spinreact will incorporate antibodies from AbD Serotec in a series of clinical diagnostic kits. • The Japanese Patent Office has granted a new patent covering MorphoSys's CysDisplay technology. • The Company introduced more detailed financial reporting, by moving from two operating segments to three - the existing Therapeutic Antibodies segment was sub-divided into Partnered Discovery and Proprietary Development. "The expansion of our proprietary antibody pipeline continues as planned with our lead compound on track to enter a phase 1b/2a study in patients in the second half of the year," commented Dave Lemus, Chief Financial Officer of MorphoSys AG. "Moreover, our partnered discovery business continues to deliver dependable cash flow, while AbD Serotec continues its upswing into sustained profitability. These two pillars of our business will allow our continued investment in proprietary antibody therapeutics, whilst maintaining overall Company profitability."www.morphosys.com/en/news_investors/p... Proprietary Development MOR103 In June 2009, MorphoSys reported positive results from the phase 1 clinical study for its lead drug MOR103, a fully human HuCAL-derived monoclonal antibody directed against Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), in healthy volunteers. The results of this study indicate that MOR103 is generally safe and well tolerated at all doses administered. The completed phase 1 trial was designed as a randomized, double-blind, placebo controlled, single ascending dose study to assess the safety, tolerability and pharmacokinetic parameters of MOR103 in healthy volunteers. In total, 63 volunteers received ascending doses of MOR103 up to a concentration of 3 mg/kg or placebo in seven dose cohorts via intravenous infusion. No maximum tolerated dose (MTD) was reached in the study. Analysis of the pharmacokinetic properties of MOR103 showed a serum halflife typical of a fully human antibody which could translate into a competitive dosing regimen. The overall safety, tolerability and pharmacokinetic properties of MOR103 provide a solid foundation for the Company's development plans, including the forthcoming phase 1b/2a study in patients. In conjunction with the presentation of final phase 1 data MorphoSys announced that the Company has submitted an application for the authorization of a subsequent phase 1b/2a clinical study in patients with active rheumatoid arthritis. The trial, which will be conducted in multiple centers in several European countries, is expected to enroll 135 patients in total, beginning in the second half of 2009. In July 2009, MorphoSys and the University of Melbourne initiated a research collaboration to investigate new therapeutic applications for MorphoSys's MOR103 program. The collaboration will focus on new therapeutic areas in which GM-CSF has recently been implicated in as yet unpublished work of researchers at the University of Melbourne. Under the terms of the agreement, MorphoSys will fund research activities at the University of Melbourne in multiple new indications. The University of Melbourne will receive an upfront payment and will be entitled to research funding, clinical milestone and royalty payments. MOR202 The preclinical development and manufacturing of MOR202 continues as planned. Start of clinical development is expected in 2010. Early-stage pipeline Work on MOR205, an early-stage cancer program, was initiated in the second quarter of 2009, and MOR203 continues as planned. Additionally, MorphoSys selected a new disease-related target molecule in inflammation, MOR104.www.morphosys.com/uploads/MOR_Q2-2009...
Nog niet geplaatst ? (met dank aan parelduiker) Persbericht 26 november 2008 Galapagos en MorphoSys gaan gezamenlijk antilichaam-medicijnen ontwikkelen voor bot- en gewrichtsziekten Combinatie van nieuwe medicijn targets en unieke technologieën om pijplijn van nieuwe antilichaam-medicijnen te creëren Klik hier om toegang te krijgen tot de audio-webcast presentatie om 14:00 uur, inbelnummer +32.2.401.53.06 Mechelen, België en München, Duitsland; 26 november 2008 – Galapagos NV (Euronext: GLPG) en MorphoSys AG (FSE: MOR) kondigen vandaag een langdurige alliantie aan om gezamenlijk medicijnen te ontwikkelen gebaseerd op antilichamen met een nieuw werkingsmechanisme tegen bot- en gewrichtsziekten, met name reuma, botontkalking en artrose. De alliantie omvat het hele traject vanaf target discovery tot aan klinisch proof of concept voor de nieuwe therapeutische antilichamen. De twee bedrijven brengen beide hun kerntechnologie en expertise in bij de alliantie. Galapagos levert targets voor antilichamen bij bot- en gewrichtsziekten, plus haar target discovery platform om additionele targets voor antilichamen te identificeren. MorphoSys gebruikt haar HuCAL technologie om volledig humane antilichamen tegen de targets van Galapagos te ontwikkelen. In de alliantie zullen de targets worden gevalideerd, zowel door in vitro als in vivo testen met de antilichamen; vervolgens zullen deze antilichamen in preklinisch en klinisch onderzoek verder worden ontwikkeld. Bij het bereiken van klinisch proof of concept in patiënten, zullen er voor de programma’s partners gezocht worden die de verdere ontwikkeling, registratie en marktintroductie zullen verzorgen. Op basis van de overeenkomst zullen Galapagos en MorphoSys zowel de R&D kosten als de toekomstige inkomsten gelijk delen. Een Joint Steering Committee met leden uit beide bedrijven zal de alliantie leiden. De bedrijven hebben een eerste set van drie targets in bot- en gewrichtsziekten geselecteerd voor de samenwerking en Galapagos is al gestart met de productie van deze target eiwitten Het ontwikkelen van antilichamen tegen deze targets zal starten in 2009. Met de technologie van Galapagos zullen in de komende jaren nog meer targets voor de alliantie geselecteerd worden. Als de alliantie succesvol verloopt, kunnen de eerste antilichamen op basis van deze nieuwe targets binnen vier à vijf jaar in de kliniek getest worden. “Met deze alliantie voegen we een antilichaam-strategie toe aan onze ontwikkeling van geneesmiddelen op basis van chemische moleculen. Galapagos is wereldleider op gebied van het ontdekken van nieuwe targets en door deze samenwerking met MorphoSys kunnen we deze nu ook voor de ontwikkeling van antilichamen inzetten. Antilichamen hebben hun sporen al verdiend bij de ontwikkeling van nieuwe medicijnen tegen ernstige ziekten waaronder ook reuma. Door beide benaderingen te gebruiken - zowel antilichamen als chemische moleculen - breiden we onze product pijplijn in bot- en gewrichtsziekten verder uit en versterken daarmee onze leidende positie op dit gebied,” aldus Onno van de Stolpe, Chief Executive Officer van Galapagos. “Door onze kaspositie en inkomstenstroom uit zowel BioFocus DPI als onze farma allianties, verkeren we in een goede positie om deze alliantie aan te gaan en waarde voor onze aandeelhouders te creëren.” “Deze alliantie is voor ons een grote stap met de toegang tot nieuwe targets voor geneesmiddelontwikkeling in ziektes waarvoor nog weinig medicijnen beschikbaar zijn. De samenwerking met Galapagos brengt twee zowel wetenschappelijk als financieel sterke partijen samen,” zet Simon Moroney, Chief Executive Officer van MorphoSys. “We zijn blij dat we onze brede ervaring op gebied van antilichamen in deze alliantie kunnen combineren met de target discovery en kennis van botziekten van Galapagos. De toegang tot nieuwe ziekte-gerelateerde targets van een dergelijk gerenommeerde partner accelereert de uitbreiding van onze eigen pijplijn van antilichamen. Deze alliantie sluit mooi aan bij onze onderzoek op gebied van ontstekingen en reuma, inclusief ons belangrijkste programma MOR103.” Met deze strategische alliantie krijgt MorphoSys toegang tot zowel een bewezen target discovery technologie, als tot de ervaring van Galapagos op het gebied van bot- en gewrichtsziekten en draagt het bij aan de uitbreiding van de pijplijn van eigen therapeutische antilichamen. De drie belangrijkste bot- en gewrichtsziekten – reuma, botontkalking en artrose – vertegenwoordigen elk een significante markt met enkele miljoenen patiënten wereldwijd. Het totale verkoopcijfer voor behandelingen van deze ziekten bedroeg in 2006 meer dan $15 miljard. Door de alliantie met MorphoSys begeeft Galapagos zich op de snel groeiende markt voor medicijnen op basis van antilichamen. In 2007 bedroeg het totale verkoopcijfer voor de 20 therapeutische antilichamen die op de markt zijn meer dan $25 miljard; dit zal naar verwachting oplopen tot ongeveer $50 miljard in 2013. Volledig humane antilichamen worden beschouwd als de volgende generatie; de meeste antilichamen die op dit moment worden ontwikkeld zijn van humane oorsprong. De gemiddelde tijd die nodig is vanaf ontdekking tot preklinische ontwikkeling voor een antilichaam is slechts twee tot drie jaar, aanmerkelijk korter dan de gemiddelde zes jaar voor kandidaat medicijnen uit chemische moleculen. Antilichamen hebben ook een grotere kans op succes in het ontwikkelingstraject naar geneesmiddel.www.glpg.com/press/2008/35%27.pdf "Het ontwikkelen van antilichamen tegen deze targets zal starten in 2009. " eens kijken of daar nog wat over gemeld wordt bij de H1-cijfers volgende week vrijdag.
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