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Morphosys-Galapagos, Therapeutic Antibodies
Volgen
Toert schreef op 9 augustus 2019 21:29 :
[...]
veel van die aandelen hoeven enkel in de FA-excel gestopt worden, elk kwartaal, en dan kijk je er niet meer naar om. Dingen zoals Elia of Sofina zijn gewoon maak je slapend rijk aandeeltjes. Zullen geen sprongen maken zoals gala, maar de schildpad wint van de haas, is het niet ?
Welke zijn jouw favoriete aandelen? De Col tel ik niet mee.
Marcel H. schreef op 9 augustus 2019 21:44 :
[...]
Welke zijn jouw favoriete aandelen? De Col tel ik niet mee.
zie hoger, maar zoals Nielsje aangeeft, we zijn op verkeerde forum bezig. Gelijk heeft ie.(en nu graag op het andere forum jouw andere favorietjes dan ASML en pig oil shell)
Toert schreef op 9 augustus 2019 22:15 :
[...]
zie hoger, maar zoals Nielsje aangeeft, we zijn op verkeerde forum bezig. Gelijk heeft ie.
Op welk forum kan ik dan jouw antwoord lezen?
@Toert. Jouw belangrijkste aandeel is dus Galapagos? De rest is bijzaak?
NielsjeB schreef op 9 augustus 2019 21:51 :
www.iex.nl/Forum/Topic/1323605/Galapa... Hier, marcel h.
Marcel H. schreef op 9 augustus 2019 22:22 :
[...]
Op welk forum kan ik dan jouw antwoord lezen?
Het draadje "waar beleggen jullie nog meer in" op het gala-forum. Graag hier alleen info mbt tot morphosys aub!
RBC is ook wakker geworden tav MOR208 koersdoel van 65 naar 130 als analist geef je feitelijk toe dat je er eerst geen kijk op had december 2017 kwam Morphosys al met geweldige MOR208 data
Bryan Garnier & Co Morphosys (Buy) PT € 125 (11th September 2019)Next Catalyst: 29th October 2019 - Q3 results The right CEO to make MorphoSys a commercial-stage company Very positive first impression from meeting with new CEO. We had the opportunity to meet MorphoSys’ new CEO Jean-Paul Kress in London yesterday, just a few days after he took over the position. Coming from Syntimmune (sold for USD1.2bn to Alexion in Sept. 2018), JPK has a solid background in commercial operations as well as in immunology. Among his top priorities, he particularly highlighted 1/the launch of MOR208 in the US, 2/ ongoing partnership discussions and 3/ his willingness to create further value from the pipeline. We believe him to be a perfect fit to prepare MorphoSys’ transition to a biopharma company with commercial operations thanks to his extended experience from blue-chip pharma companies (Genzyme, Biogen, Gilead), as well as his expertise to hire and build teams which will be particularly helpful to structure the US subsidiary. Finally, we think that his dealmaking skills will be highly relevant to strike one or more partnerships.Several catalysts could drive the stock in coming months Among them are: the BLA filing for Tafa in the US and in the EU before the end of the year, leading to a decision before the end of Q2 2020 in the US; B-MIND futility analysis in Q4 which could be followed by results in Q1 2020 and finally, the announcement of a partnering deal for Europe. While the filings are quite anticipated now that the regulatory strategy has been disclosed (see our last report), we believe that B-MIND results could be a key catalyst for two reasons: 1/further expand Tafa’s potential in DLBCL and 2/trigger the anticipated partnering deal in Europe (if not signed before).B-MIND futility analysis could lead to final data in Q1 2020 As a reminder, B-MIND is a phase II/III study evaluating Tafa in combination with bendamustine vs rituximab + bendamustine. A futility analysis has been set for Q4 and will result in the study continuing in all comers or biomarker selected patients. While final data is expected in Q1 2020 if all-comers pass futility, an additional year will be needed if only subgroups pass futility. Given that a longer-than-expected duration of response in the overall patient population has been shown, suggesting better efficacy in the Tafa arm, we believe that the probability of a complete failure of B-MIND is now really low. If positive, these results could be a significant catalyst by further broadening combination potential with either Bendamustine or Rituximab.Could Astrazeneca be the right partner outside of the US? As reported in our OncoDay 2019 paper, AstraZeneca is seeking to become more ambitious in haematology following positive data sets obtained with Calquence in CLL. From a situation where Celgene used to be the partner in the field, AZ is now candidate to make acquisitions of phase II/early phase III assets to build up its own franchise around the Calquence backbone. For these reasons, we believe that ex-US rights of Tafa could be a perfect addition in order to strengthen AZ’s haematology portfolio given its potential in DLBCL as well as its later stage positioning in CLL.
Overige koersdoelverhogingen van deze week: ma. 09-09 Berenberg Bank Buy PT 150euro woe. 11-09 JPmorgan Overweight PT 130euro
Gaat ook al heel hard naar beneden... :(
de tuinman schreef op 3 oktober 2019 17:03 :
Gaat ook al heel hard naar beneden... :(
Vandaag niet want feestdag in Duitsland vanwege de eenwording. Dus vandaag geen handel in Duitsland.
New Head-to-Head Data Show Taltz® (ixekizumab) Superiority versus TREMFYA® (guselkumab) in People with Moderate to Severe Plaque Psoriasisseekingalpha.com/pr/17652103-new-head... Lijkt me relevant voor Morphosys.
Voor Galapagos en Morphosys, die in verhouding 50/50, het molecuul MOR106 hebben ontwikkeld en uit-gelicenseerd aan Novartis is weer relevant:CITI rapport van 2-10-2019 geplaatst door Avantiavanti "Other comments from the CEO (Galapagos) included potential data in 3Q20 on GLPG1972 in osteoarthritis, although they will have to conduct MRI scans on 850 patients, which could delay to 4Q20. Regarding MOR106 , currently in phase 2 for Atopic Dermatitis, Novartis is expected to shortly announce which other 2-3 indications they will be pursuing with this antibody". Dat is goed nieuws. Best kans dat naast eczeem (atopic dermatitis) er ook studies voor plaque psoriasis worden opgestart door Novartis en dan nog 1/2 indicaties. Positief nieuws dat Novartis vol doorgaat met MOR106.
Patent (12/09/19) voor Galapagos en Morphosys mbt MOR106: ANTIBODIES AND PHARMACEUTICAL COMPOSITIONS THEREOF FOR THE TREATMENT OF AUTOIMMUNE SKIN DISEASESpatentscope.wipo.int/search/docs2/pct... SUMMARY OF THE INVENTION [0008] The present invention provides antibody or antibody fragments specific for IL-17C, in particular MOR106, for use in the treatment of autoimmune skin diseases. In particular the antibody or antibody fragment is for use in the treatment of T-cell mediated autoimmune skin diseases, B-cell mediated autoimmune skin diseases, granulomatous autoimmune skin diseases or neutrophilic skin diseases.
Bryan Garnier & Co Morphosys (Buy) PT € 125 (7th October 2019)Too early to draw any conclusion from Taltz/Tremfya head-to-head trial Lilly claims victory over Tremfya, but still a long way to go Last Thursday, Eli Lilly announced that Taltz met its primary and all major secondary endpoints up to week 12 in the phase IV IXORA-R trial. This study is the first of its kind comparing an IL-17 inhibitor and an IL-23/p19 inhibitor using the Psoriasis Area Severity Index (PASI) 100 score as the primary endpoint. In detail, Taltz completely cleared moderate to severe plaque psoriasis in 41.3% of the patients at week 12 compared with 24.9% for Tremfya. While Taltz’s superiority seems meaningful at first sight, we must bear in mind that 12 weeks of follow-up is not relevant to capture Tremfya’s full efficacy as shown in its different studies as well as in the head-to-head trial against Cosentyx.Tremfya is characterised by a slower onset of action Back in December 2018, Janssen announced that Tremfya demonstrated superiority over Cosentyx (an IL-17 inhibitor from Novartis) in a head-to-head phase III trial (ECLIPSE) in patients with moderate to severe plaque psoriasis. While ultimately grabbing long-term superiority over Cosentyx at week 48, the proportion of patients who achieved a response in the Tremfya arm was numerically lower at week 12 compared to Cosentyx arm. Those findings were consistent with cross-study comparisons between Tremfya and Cosentyx and can be explained both by the respective dosing regimens and mechanisms of action. Tremfya was dosed every eight weeks with one additional dose at week 4 whereas Cosentyx was dosed every four weeks, with three additional doses at weeks 1, 2, and 3.IXORA-R’s design is by essence unfavourable to Tremfya Given its specific profile, Tremfya should show its true potential on a more extended follow-up (around 48 weeks as seen in ECLIPSE). However, IXORA-R will only compare the two drugs until week 24, downplaying Tremfya’s potential by design. All in all, the additional data at week 24 expected to be released by Lilly in 2020 should only confirm what we already know: IL-17 inhibitors have a more rapid onset of action that IL-23 inhibitors such as Tremfya. We doubt this is material from a clinical standpoint over the long run, since it relates to a chronic disease. So, in the end, we believe it is a non-event and each family of drugs will keep its respective marketing arguments. We do not believe it will impact the current dynamics in the pso market, considering moreover that they are all helping biologics take share from old topical drugs.
Woman in Chains32 schreef op 3 oktober 2019 19:07 :
Voor Galapagos en Morphosys, die in verhouding 50/50, het molecuul MOR106 hebben ontwikkeld en uit-gelicenseerd aan Novartis is weer relevant:
CITI rapport van 2-10-2019 geplaatst door Avantiavanti "Other comments from the CEO (Galapagos) included potential data in 3Q20 on GLPG1972 in osteoarthritis, although they will have to conduct MRI scans on 850 patients, which could delay to 4Q20. Regarding MOR106 , currently in phase 2 for Atopic Dermatitis, Novartis is expected to shortly announce which other 2-3 indications they will be pursuing with this antibody". Dat is goed nieuws. Best kans dat naast eczeem (atopic dermatitis) er ook studies voor plaque psoriasis worden opgestart door Novartis en dan nog 1/2 indicaties.
Positief nieuws dat Novartis vol doorgaat met MOR106.
Tja, en nu?
de tuinman schreef op 28 oktober 2019 22:55 :
[...]
Tja, en nu?
Alles wordt gestopt. MorphoSys bails on dermatitis candidate MOR106 Oct. 28, 2019 5:05 PM ET|About: MorphoSys AG (MOR)|By: Douglas W. House, SA News Editor MorphoSys AG (NASDAQ:MOR) and development partners Galapagos NV (NASDAQ:GLPG) and Novartis Pharma AG (NYSE:NVS) have decided to stop development of MOR106 for atopic dermatitis after an interim analysis of a Phase 2 study showed a low probability of success. All studies will be terminated. MOR and GLPG jointly discovered the IL-17C inhibitor while Novartis owned exclusive development and commercialization rights under a September 2018 agreement.
dit klinkt al beter MorphoSys AG / Key word(s): Study results 29.10.2019 / 19:40 The issuer is solely responsible for the content of this announcement. ________________________________________ Media Release Planegg/Munich, Germany, October 29, 2019 Primary Endpoint met in Real-World Data Study Demonstrating Clinical Superiority of the Combination of Tafasitamab and Lenalidomide compared to Lenalidomide alone - Primary endpoint met: Statistically significant superior best objective response rate seen in combination treatment of tafasitamab with lenalidomide (L-MIND) when compared to a real-world data matched control cohort of lenalidomide alone (Re-MIND) - Superiority consistently observed across all secondary endpoints and pre-specified statistical sensitivity analyses - Data support plan to submit BLA for tafasitamab in combination with lenalidomide based on L-MIND study results before end of 2019; rolling submission of BLA initiated MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today announced topline results from the primary analysis of the retrospective observational matched control cohort (Re-MIND). This study was designed to compare the effectiveness of lenalidomide monotherapy based on real-world patient data with the efficacy outcomes of the tafasitamab/lenalidomide combination, as investigated in MorphoSys's L-MIND trial. Re-MIND collected outcome data from 490 non-transplant eligible patients with relapsed/ refractory diffuse large B cell lymphoma (r/r DLBCL) who had received lenalidomide monotherapy in the U.S. and the EU in a real-world setting. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy. ORR was 67.1% (95% confidence interval (CI): 55.4-77.5) for the tafasitamab/ lenalidomide combination, compared to 34.2% (CI: 23.7-46.0) for the lenalidomide monotherapy (p<0.0001). Superiority was consistently observed across all secondary endpoints, including complete response (CR) rate (tafasitamab/lenalidomide combination 39.5%; CI: 28.4-51.4 versus lenalidomide monotherapy 11.8%; CI: 5.6-21.3; p<0.0001), as well as in pre-specified statistical sensitivity analyses. In addition, there was a significant difference observed in overall survival, which was not reached in the tafasitamab/lenalidomide combination as compared to 9.3 months in the lenalidomide monotherapy (hazard ratio 0.47; CI: 0.30-0.73; p<0.0008). "Encouraged by the results we achieved with the real-world data approach, we re-affirm our plans to pursue advancement of tafasitamab to market in combination with lenalidomide as a potential, chemo-free treatment option for patients with r/r DLBCL, subject to FDA approval. The data announced today complement the previously published data of the single-arm L-MIND study and MorphoSys has started the rolling submission of our BLA to the FDA, which we plan to complete by end of this year," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "I'm very excited about this real-world data approach of the Re-MIND trial to isolate a single-agent contribution of tafasitamab in combination with lenalidomide in a matched patient population in r/r DLBCL. This study further strengthens the synergistic effect of tafasitamab and lenalidomide, as already observed in the L-MIND trial," said Pier Luigi Zinzani, M.D., Ph.D., Professor of Hematology, Head of Lymphoma Group, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, Bologna, Italy, and one of the lead investigators in MorphoSys's Re-MIND study. Details of the L-MIND primary analysis were published on June 22, 2019, and can be found here.www.morphosys.com/media-investors/med... www.morphosys.com/media-investors/med...
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