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Morphosys-Galapagos, Therapeutic Antibodies

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harvester 10 januari 2017 14:34

Johnson + Johnson fool artikel noemt niet Morphosys maar wel haar product dat zij aan JnJ in licentie heeft gegeven: - citaat - All indications point to guselkumab being J&J's next blockbuster drug. -

The 2 Critical Cogs That Pushed Johnson & Johnson 12% Higher in 2016
Hint: It's all about the pharmaceutical segment!
Sean Williams
(TMFUltraLong)
Jan 9, 2017 at 12:41PM
TopicsJohnson & JohnsonAlex GorskyBiosimilar

The other major catalyst for J&J was the release of pivotal phase 3 data on guselkumab, a next-generation experimental drug designed to treat moderate-to-severe plaque psoriasis. It was no surprise that guselkumab mopped the floor with the placebo given that it targets a protein known as interleukein-23, which is known to have a higher specificity when it comes to immune response disorders of the skin. At the 16-week mark, guselkumab led 73% of patients to near-complete skin clearance compared to just 2.9% of patients taking the placebo. The real shock was that it left the best-selling drug in the world, AbbVie's Humira, in the dust at both the 16-week mark for near-clearance (73% vs. nearly 50% for Humira), and at the 48-week mark (81% for guselkumab vs. 55% for Humira). All indications point to guselkumab being J&J's next blockbuster drug.

Investors should also keep an eye on whether J&J decides to go shopping in 2017. CEO Alex Gorsky has made it clear that J&J is looking to supplement its organic growth with mergers and acquisitions (M&A), and in recent weeks it's been courting Swiss-based Actelion and its portfolio of lung disease drugs. I'm personally not a fan of a potential deal between the two companies, but something tells me this may not be J&J's only foray into M&A this year.

r.search.yahoo.com/_ylt=A0LEV0Lv4XRY7...

harvester 12 januari 2017 12:52

MorphoSys Partner to Start Phase 2 Trial with Bimagrumab in Obese Patients with Type 2 Diabetes

January 12, 2017 / 9:09 am, CET

Planegg/Munich, Germany, January 12, 2017

MorphoSys Partner = Novartis) to Start Phase 2 Trial with Bimagrumab in Obese Patients with Type 2 Diabetes

According to information published on clinicaltrials.gov, the randomized, subject- and investigator-blinded study will enroll 60 obese adult patients with type 2 diabetes to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab compared to placebo. The study is not yet open for enrollment.

The study's primary outcome measures comprise the change in fat body mass at weeks 24 and 48. Secondary outcome measures include mean change from baseline in HbA1c, insulin resistance as measured by the homeostatic model assessment (HOMA-IR), fasting insulin and glucose.

Further detailed information about the trial can be found at clinicaltrials.gov.

harvester 12 januari 2017 12:58

vandaag overigens bij JPM conferentie Morphosys CEO present.

Er wordt een webcast van gemaakt. Daar zal het Novartis obesitas verhaal ook aangestipt worden maar de status van marktaanvraag door JNG van een voor hen door Morphosys ontwikkeld product is voor Morphosys van belang voor hun 2017 prognose.
Wellicht is de webcast ook interessant voor degenen die alleen Galapagos volgen i.v.m. samenwerking met Galapagos.

harvester 12 januari 2017 18:22

Morphosys o.a. 38 Clinical Data Points Expected in 2017 - incl. Mor106

www.morphosys.com/sites/default/files...

Verder willen zij ook commerciële organisatie in 1 land optuigen.
Wellicht in de verkoop ook samenwerken met Galapagos?

harvester 21 februari 2017 11:43

MorphoSys CHX:MOR, DE0006632003 stijgend 51,860 +1,590 (+3,16%) na nieuws

February 21, 2017 / 7:30 am, CET

Planegg/Munich, Germany, February 21, 2017

MorphoSys's Subsidiary Lanthio Pharma Initiates First-in-Human Clinical Study with Lanthipeptide MOR107

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its fully owned subsidiary Lanthio Pharma B.V., Groningen, Netherlands, has initiated a phase 1 clinical study with MOR107. MOR107, a selective agonist of the angiotensin II receptor type 2, is a lanthipeptide based on Lanthio Pharma's proprietary technology platform and the first lanthipeptide in MorphoSys's clinical pipeline.

Dit dus in aanvulling op Leerink presentatie:
www.morphosys.com/sites/default/files...

harvester 21 februari 2017 16:46

quote:
harvester schreef op 21 februari 2017 11:43:
MorphoSys CHX:MOR, DE0006632003 stijgend 51,860 +1,590 (+3,16%) na nieuws

February 21, 2017 / 7:30 am, CET

Planegg/Munich, Germany, February 21, 2017

MorphoSys's Subsidiary Lanthio Pharma Initiates First-in-Human Clinical Study with Lanthipeptide MOR107

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its fully owned subsidiary Lanthio Pharma B.V., Groningen, Netherlands, has initiated a phase 1 clinical study with MOR107. MOR107, a selective agonist of the angiotensin II receptor type 2, is a lanthipeptide based on Lanthio Pharma's proprietary technology platform and the first lanthipeptide in MorphoSys's clinical pipeline.

Dit dus in aanvulling op Leerink presentatie:
www.morphosys.com/sites/default/files...

NU EUR 52,420 +2,150 (+4,28% loopt nu aardig op.
Galapagos daarentegen vandaag nog niet echt uit de startblokken maar het is nog geen vrijdag.

flosz 27 september 2017 15:16

Ook hier even plakken...
www.morphosys.com/media-investors/med...

Bijlage:

nelis h 23 oktober 2017 22:47

MorphoSys Receives FDA Breakthrough Therapy Designation for Its Antibody MOR208 in Relapsed/Refractory DLBCL (news with additional features)

nelis h 23 oktober 2017 22:49

MorphoSys Receives FDA Breakthrough Therapy Designation for Its Antibody MOR208 in Relapsed/Refractory DLBCL

Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in combination with cancer drug lenalidomide

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to MOR208, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation. MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19 which is currently in clinical development in blood cancer indications.

FDA Breakthrough Therapy designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease.

DLBCL is the most frequent type of malignant lymphoma worldwide and accounts for approximately 30% of all non-Hodgkin lymphomas. Between 30% and 40% of all patients with DLBCL either fail to respond to or show a relapse to initial therapy.

"DLBCL is a very aggressive lymphoma. In particular, those patients who fail standard treatments are in need of more therapeutic options. We look forward to working closely with the FDA and to develop MOR208 as a potential new treatment option for these patients as quickly as possible," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

FDA's Breakthrough Therapy designation is based on preliminary data from the ongoing phase 2 L-MIND study (NCT02399085), which is evaluating the safety and efficacy of MOR208 in combination with lenalidomide in patients with R/R DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation. Preliminary data based on 34 eligible patients presented at ASCO 2017, showed an objective response rate (ORR) of 56% and a complete response rate of 32%.

"For MorphoSys, relapsed/refractory DLBCL is a key development focus. We expect to report further data from our ongoing phase 2 L-MIND trial with MOR208 plus lenalidomide at this year's American Society of Hematology conference in December. In addition, we are currently evaluating MOR208 in combination with bendamustine in our phase 3 B-MIND trial. MorphoSys intends to speed up and potentially broaden the development of MOR208 in other indications of unmet need," Dr. Peters continued.

harvester 23 oktober 2017 23:13

Beste Nelis
Bedankt voor het plaatsen!

Ik had het nog niet gezien. Ongetwijfeld zal de belangstelling voor Morphosys verder toenemen.
De laatste tijd was het vrij stil.
Begin nov. Komen de 3e kwartaal cijfers met dan hopelijk ook nieuws over de eerste royalities van JNJ voor een product die dochter Jansen van Morpho in licentie heeft.

harvester 24 oktober 2017 10:06

quote:
nelis h schreef op 23 oktober 2017 22:47:
MorphoSys Receives FDA Breakthrough Therapy Designation for Its Antibody MOR208 in Relapsed/Refractory DLBCL (news with additional features)

EUR 5,50 gestegen naar EUR 79 op xetra beurs bij een volume van nu 166,000 stuks n.a.v. dit bericht.

harvester 24 oktober 2017 14:28

quote:
harvester schreef op 24 oktober 2017 10:06:
[...]

EUR 5,50 gestegen naar EUR 79 op xetra beurs bij een volume van nu 166,000 stuks n.a.v. dit bericht.

Nu dus EUR 6.12 gestegen naar bijna EUR 80 op een omzet van ruim 400,000 stuks op xetra beurs omzet 2x normale dagomzet.

holenbeer 24 oktober 2017 17:49

Heb de helft eruit gedaan op 79,5, hoop die weer op te pakken op 77. Loopt vaak weer iets terug na enige tijd. En zo niet, dan niet.
Zie de kiadissen, pharming, ablynxen van deze wereld.

harvester 3 november 2017 12:39

Morphosys AG (MOR.DE)stijgt weer:XETRA - 78.90+1.45 (+1.87%)

komt natuurlijk door het bericht van gisteren wat hieronder staat.
Dit MOR208 is volledig eigendom en (nog niet) gepartnered.

Ik denk dat de stijging nu gaat doorzetten. Over een paar dagen 3e kwartaalcijfers met de eerste royalties van een ander product.

November 02, 2017 / 7:30 am, CET

Planegg/Munich, Germany, November 2, 2017

MorphoSys Announces Presentation of Clinical Data on Proprietary Blood Cancer Compound MOR208 at Upcoming American Society of Hematology Annual Meeting 2017

- Abstract on preliminary data from ongoing phase 2 trial with antibody MOR208 in combination with lenalidomide in relapsed/refractory DLBCL accepted for poster presentation at ASH 2017

- Poster presentation will take place on December 11, 2017, 6:00-8:00pm EST (December 12, 0:00-2:00am CET)

- Conference call by MorphoSys scheduled for December 12, 2017, 11:00am EST (5:00pm CET)

nelis h 3 november 2017 13:40

op het duitse forum begrijp ik met mijn slechte duits dat MOR106 in licentie is van Xencor

"Für Xencor entscheidend ist zunächst einmal, dass MOR208 zugelssen wird, weil dann 187 Mio. USD an Xencor fließen werden. Und in dieser Hinsicht sieht es gut aus."

www.wallstreet-online.de/diskussion/1...

een post van : 02.11.17 09:17:53

harvester 3 november 2017 14:29

quote:
nelis h schreef op 3 november 2017 13:40:
op het duitse forum begrijp ik met mijn slechte duits dat MOR106 in licentie is van Xencor

"Für Xencor entscheidend ist zunächst einmal, dass MOR208 zugelssen wird, weil dann 187 Mio. USD an Xencor fließen werden. Und in dieser Hinsicht sieht es gut aus."

www.wallstreet-online.de/diskussion/1...

een post van : 02.11.17 09:17:53

Interessante Duitse site. Daar ga ik wat meer in verdiepen.

Die Eur 187 miljoen te betalen aan xencor als Mor208 op de markt komt is fors, maar ongetwijfeld gaat Morphosys een partner contracteren die er aan Morphosys veel meer voor gaat betalen.
Eerlijk gezegd wist ik niet dat voor MOr208 nog licentieverplichtingen bestonden.

Mor106 is volgens mij niet in licentie verkregen maar zelf ontwikkeld door Gala en Morphosys samen.

harvester 5 november 2017 16:54

Op 7 november komt Morpho met de 3 kwartaalcijfers.
Deze worden interessant omdat dan.iets zichtbaar kan worden over royalties over door JnJ verkochte medicijnen.
Ook zal dan wel iets gemeld worden over MOR106 en MOR 208.

wellicht melden Morpho en Gala gezamenlijk iets over MOR 106 voorafgaand aan die q3 cijfers.

harvester 5 november 2017 17:03

quote:
harvester schreef op 5 november 2017 16:54:
Op 7 november komt Morpho met de 3 kwartaalcijfers.
Deze worden interessant omdat dan.iets zichtbaar kan worden over royalties over door JnJ verkochte medicijnen.
Ook zal dan wel iets gemeld worden over MOR106 en MOR 208.

Overigens nadert de morpho koers die van Gala. Wellicht tijd voor een overname door Gala als white knight of door een partij als Novartis. Kan ook een partner deal worden inzake MOR208.
Genoeg leven in de brouwerij mogelijk.

harvester 7 november 2017 12:22

3e kwartaal resultaten Morphosys, vanmiddag conference call.

www.morphosys.com/media-investors/med...

Het gaat nog steeds goed met deze partner van Galapagos.
cash position of EUR 319.5 million
Eerste royalties van Johnsonand Johnson over het 3e kwartaal zitten er nog niet in omdat de gegevens nog niet door JnJ zijn gegeven, maat wat in het vat zit komt er wel uit.

"As first royalty reporting from Janssen has not been received yet, royalties on net sales for TremfyaTM (guselkumab) cannot be accurately projected at this point in time. Hence the guidance for the financial year 2017 does not include any assumptions on royalty income for sales on TremfyaTM (guselkumab)."

Opvallend genoeg geen woord over MOR106, maar daar heeft Galapagos het voortouw in de opzet van de vervolgstudie na het gezamenlijke persbericht van eind september.
Nadruk ligt meer op MOR208, met positieve resultaten op kankergebied.

Wellicht wordt in de conference call vanmiddag bij de outlook bespreking meer gezegd bijvoorbeeld wanneer er naar verwachting nieuws over MOR106 komt, naast de andere zaken die komende tijd voor Morphosys spelen.

MorphoSys will hold its conference call and webcast today to present the third quarter 2017 and first nine months 2017 financial results and the further outlook for 2017.

Dial-in number for the analyst conference call (in English) at 2:00 pm CET; 1:00 pm GMT; 8:00 am EST (listen-only):
Germany: +49 (0) 89 2444 32975
For UK residents: +44 (0) 20 3003 2666
For US residents: +1 202 204 1514

harvester 8 november 2017 23:05

finance.yahoo.com/news/edited-transcr...

Stukje hieruit waar MOR106 en "our friends at Galapagos" worden genoemd:

Simon E. Moroney, Morphosys AG - Chairman of Management Board and CEO [21]

--------------------------------------------------------------------------------

So the planning for that Phase II trial is ongoing at the moment with our friends at Galapagos. And it's simply too early to say what dose we're going to go with at this stage.

Thomas J. Schießle, EQUI.TS GmbH - Research Analyst [22]

--------------------------------------------------------------------------------

Do you have any clue concerning the competition, which dose might be appropriate?

--------------------------------------------------------------------------------

Simon E. Moroney, Morphosys AG - Chairman of Management Board and CEO [23]

--------------------------------------------------------------------------------

This is the only IL-17C antibody in the clinic. In fact, the only program as far as we're aware against IL-17C at all in clinical trials right now. So we've got nothing to go off other than that -- our own Phase I study, which will, of course, be a guide for us. So trying to read across from other drugs with other mechanisms doesn't really help us there. So it's really a case of looking at the data we have from Phase I, and the modeling data and designing the Phase II trial accordingly.

--------------------------------------------------------------------------------

Thomas J. Schießle, EQUI.TS GmbH - Research Analyst [24]

--------------------------------------------------------------------------------

And commentary to the time frame.

--------------------------------------------------------------------------------

Simon E. Moroney, Morphosys AG - Chairman of Management Board and CEO [25]

--------------------------------------------------------------------------------

As I said, we're currently planning the Phase II trial with Galapagos right at the moment. We're confident that, that will get going next year. I can't give you color on precisely when that will get going. But it is based on the encouraging data we've seen, which we're very happy about the Phase I data. But it's a priority for both companies. And so we're looking to push it forward as quickly as possible.

--------------------------------------------------------------------------------

eindstukje Ook weer Mor106

imon E. Moroney, Morphosys AG - Chairman of Management Board and CEO [27]

--------------------------------------------------------------------------------

Thank you. And to conclude the call, I'd just like to remind you of the main points to takeaway. First, MOR208. We'll use the momentum from the FDA's Breakthrough Therapy designation to focus on developing 208 plus lenalidomide in relapsed/refractory to approval as fast as possible. I'd like to remind you that data from the ongoing L-MIND trial will be presented at ASH in Atlanta on December 11 from 6:00 p.m. to 8:00 p.m. Eastern Standard Time as well as in our conference call for investors and analysts one day later, December 12, at 11:00 a.m. Eastern Standard Time. Further details on that will follow. MOR202, we're happy with progress on 202, both clinically and in terms of the work we're doing to secure the program's future.

106, we're excited about the potential of this compound based on the promising data we've seen so far. I look forward to working with our partners from Galapagos on further development.

Guselkumab, Tremfya, will soon have insight into the U.S. launch, and look forward to approval in Europe. Altogether, it will be busy last few weeks of the year, and we look forward to keeping you informed of progress.

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