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Morphosys-Galapagos, Therapeutic Antibodies
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www.morphosys.com/media-investors/med... MorphoSys AG Reports Third Quarter 2019 Financial Results Conference call and webcast (in English) to be held on October 30, 2019 at 2:00pm CET (1:00pm GMT/9:00am EDT) - Dr. Jean-Paul Kress started as new CEO of MorphoSys, September 1, 2019 "The third quarter of 2019 has significantly advanced our preparations for seeking regulatory approval in the U.S. for our key asset tafasitamab," said Dr. Jean-Paul Kress, Chief Executive Officer of MorphoSys. "Today we announced compelling topline data of Re-MIND, our retrospective study in relapsed/refractory DLBCL. Re-MIND compares real-world data based effectiveness of lenalidomide monotherapy with the efficacy outcomes of the tafasitamab/ lenalidomide combination in our L-MIND trial. We are very pleased that the study met its primary endpoint, showing a superior best objective response rate (ORR) of the tafasitamab/ lenalidomide combination compared to lenalidomide monotherapy. The data complements the L-MIND primary analysis data we published in June this year and considerably supports the BLA submission, which we plan to complete by end of this year. Rolling submission was initiated and the pre-clinical data package was already submitted to the FDA.
Wat is dit voor een laffe koersstijging??? Ik had wel iets/veel meer verwacht!
Kan iemand het gebrek aan werkzaamheid van MOR106 in de huidige studies verklaren met de resultaten van het fase 1 onderzoek? Daar werd toch een duidelijke werkzaamheid gezien.About MOR106 results of a Phase 1 study in atopic dermatitis (AD) Clinical data of a MOR106 Phase 1 trial in AD patients were presented at the American Academy of Dermatology (AAD) conference in February 2018 in San Diego. After 4 infusions in weekly intervals, an improvement of at least 50% in the Eczema Area and Severity Index (EASI-50) was observed in 83% of patients (5 out of 6) at week 4 at the highest dose level of MOR106. The onset of activity occurred within two to four weeks, depending on the dose administered. Pooled data across all dose cohorts showed that AD patients treated with MOR106 achieved an EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at week 4, 8, 12, and 14, respectively. For patients receiving placebo, the EASI improvement was 32%, 40%, 38%, and 50%. MOR106 was generally well tolerated in this trial. Any adverse drug reactions observed in relation to MOR106 were mild-to-moderate and transient in nature. No serious adverse events or infusion-related reactions were recorded (Thaçi et al., 2018, AAD).
Pokerface schreef op 30 oktober 2019 14:48 :
Kan iemand het gebrek aan werkzaamheid van MOR106 in de huidige studies verklaren met de resultaten van het fase 1 onderzoek? Daar werd toch een duidelijke werkzaamheid gezien.
About MOR106 results of a Phase 1 study in atopic dermatitis (AD) Clinical data of a MOR106 Phase 1 trial in AD patients were presented at the American Academy of Dermatology (AAD) conference in February 2018 in San Diego. After 4 infusions in weekly intervals, an improvement of at least 50% in the Eczema Area and Severity Index (EASI-50) was observed in 83% of patients (5 out of 6) at week 4 at the highest dose level of MOR106. The onset of activity occurred within two to four weeks, depending on the dose administered. Pooled data across all dose cohorts showed that AD patients treated with MOR106 achieved an EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at week 4, 8, 12, and 14, respectively. For patients receiving placebo, the EASI improvement was 32%, 40%, 38%, and 50%. MOR106 was generally well tolerated in this trial. Any adverse drug reactions observed in relation to MOR106 were mild-to-moderate and transient in nature. No serious adverse events or infusion-related reactions were recorded (Thaçi et al., 2018, AAD). Misschien vertelden de laatste uitslagen dat dit product niet kan concurreren met andere medicatie?
Vreemd dat het pb niet nabeurs kwam.
www.reuters.com/article/us-morphosys-... Morphosys to boost size of tafasitamab drug trial on encouraging interim data
Kan iemand mij ff helpen met een toelichting over de rol van en belang voor GLPG. Thanks
Paniekvogel schreef op 20 november 2019 18:11 :
Kan iemand mij ff helpen met een toelichting over de rol van en belang voor GLPG.
Thanks
Een samenwerkings-project Gal met Mor is pas gesneuveld. Dus er is geen belang meer met/voor Galapagos. Maar ik heb wel wat aandelen Mor....heb goede ervaringen met Biotech met een bredere pipe-line.
de tuinman schreef op 20 november 2019 18:17 :
[...]
Een samenwerkings-project Gal met Mor is pas gesneuveld. Dus er is geen belang meer met/voor Galapagos.
Maar ik heb wel wat aandelen Mor....heb goede ervaringen met Biotech met een bredere pipe-line.
Dank je, ik was ook in de veronderstelling dat GLPG het onderzoek had beëindigd en dacht dat ik het niet goed had begrepen.
Het lijkt me dat volgens clinical trials de lopende mor106 zoeken netjes afgewerkt worden, zijn paar dagen geleden op active, not recruiting gezet. Einddatum is nu paar maanden vroeger.
Toert schreef op 20 november 2019 20:54 :
Het lijkt me dat volgens clinical trials de lopende mor106 zoeken netjes afgewerkt worden, zijn paar dagen geleden op active, not recruiting gezet. Einddatum is nu paar maanden vroeger.
Ik denk dat het te maken heeft met het verder verzamelen van info. Mor106 is niet geflopt wegens veiligheidsproblemen en Novartis gaat kijken wat er nog verder mogelijk is.
Doodstil hier. Jammer. Ook hier worden nieuwe records gezet.
de tuinman schreef op 9 januari 2020 14:46 :
Doodstil hier. Jammer. Ook hier worden nieuwe records gezet.
Time for me to break the silence...Bryan Garnier & Co Morphosys (Buy) PT € 140 Fair Value Under Review vs. EUR140 (13th January 2020)Highly anticipated MOR208 deal finally signed with… Incyte The perfect scenario for Tafasitamab (MOR208) Less than 6 months after the beginning of its term as CEO of MorphoSys, Jean-Paul Kress has delivered a much-anticipated agreement that lives up to high expectations for several reasons: 1/ Incyte has a well-established experience in haematology and oncology alongside an extended commercial footprint in key territories; 2/ Cocommercialization in the US with MorphoSys leading the strategy while Incyte has exclusive rights outside of the US; 3/ Strong financial terms with a USD 750m upfront payment, USD 1.1bn in potential milestones and an equity investment into MorphoSys of USD150m at a premium at signing of the agreement and 4/ this collaboration will go beyond DLBCL alone, with follicular lymphoma, marginal zone lymphoma and CLL.Incyte: a perfect match for Tafa With its strong capabilities in haematology and oncology, we believe that Incyte is the right partner to further develop tafasitamab, beginning with the combination of Tafa with Incyte’s PI3K-delta inhibitor parsaclisib in R/R B-cell malignancies. On top of that, Incyte will be responsible for any potential registration-enabling studies in CLL and a phase III trial in R/R FL/MZL.Strong financial terms for Morphosys As reported above, MorphoSys is entitled to an upfront payment of USD 750m alongside potential milestones (developmental, regulatory and commercial) of USD 1.1bn. Upon signing of the agreement, Incyte will make an equity investment into MorphoSys of USD 150m in new ADS at an unknown premium for now. For the US, the two companies will co-commercialize tafa and will share profits and losses on a 50:50 basis. Ex-US, Incyte will be paying MorphoSys tiered royalties in a mid-teens to mid-twenties percentage range of net sales. Finally, the companies will share development costs at a rate of 55% (Incyte) to 45% (MorphoSys), while Incyte will cover 100% of the future developments costs for specific EU-trials.Incyte will grow Tafa beyond DLBCL While MorphoSys has historically focused only on DLBCL, it is true that this compound has a significant potential in several other indications. First of all, Incyte will combine tafa with its proprietary PI3K-delta inhibitor parsaclisib in R/R B cell malignancies. On top of that, the company will be in charge of any potential registration-enabling studies in CLL and of a phase III in RR FL/MZL. In the meantime, MorphoSys will continue to be responsible for its ongoing clinical trials, including the recently announced frontline DLBCL trial.Next catalyst will be FDA acceptance of BLA filing At the very beginning of this year, MorphoSys announced the submission of the BLA for MOR208 in R/R DLBCL to the FDA. We are now anticipating the FDA to grant this application a Priority Review status by early March.
@wall street trader: Ik las ergens dat jefferies Incyte een slechte keuze vond. Vind je daar iets van terug ? Ik dacht eerst dat de vrije val daardoor kwam, maar blijkbazr is de beweging voor alle biotech. Komt wel goed.
Toert schreef op 13 januari 2020 22:44 :
@wall street trader:
Ik las ergens dat jefferies Incyte een slechte keuze vond. Vind je daar iets van terug ?
Ik dacht eerst dat de vrije val daardoor kwam, maar blijkbazr is de beweging voor alle biotech. Komt wel goed.
9% is wel erg veel.
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