Galapagos - GLPG
Re: Galapagos - GLPG
Galapagos to showcase CAR-T point-of-care manufacturing and initial Phase 1/2 CLL data with CD19 CAR-T candidate, GLPG5201, at the EHA 2023 congress
Galapagos NV
Mon, June 5, 2023 at 10:01 PM GMT+2·8 min read
All 7 out of 7 eligible patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter’s Transformation (RT), responded to treatment (Objective Response Rate of 100%)1
GLPG5201 showed no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS)2
A functionally closed, automated manufacturing platform for cell therapies at the point-of-care will be shown at the Galapagos booth A.103 at the EHA 2023 congress
Mechelen, Belgium; 5 June 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will feature the CAR-T point-of-care manufacturing platform and will present previously disclosed initial Phase 1/2 data with CD19 CAR-T candidate, GLPG5201, at the European Hematology Association (EHA) 2023 congress, taking place from 8 June to 11 June 2023 in Frankfurt, Germany.
“Patients who develop rrCLL and become resistant to new agents have a very poor prognosis and a significant high unmet medical need for novel therapeutic options such as CAR-T cell therapy. The previously disclosed initial efficacy, safety and feasibility data from the ongoing EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, manufactured at point-of-care, are encouraging, and we are on track to provide Phase 1 topline results around mid this year,” said Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. “Our innovative approach in CAR-T cell therapy development and manufacturing underscores our commitment to accelerating transformational innovation to address the unmet needs of patients with advanced cancers, and we very much look forward to meeting and connecting with you at our booth.”
Details of the abstract P1399:
Title
Authors
Presentation date/time
Initial Clinical Results of Euplagia-1, a Phase I/II Trial of Point-of-Care
Manufactured GLPG5201 in R/R CLL/SLL with or without Richter's transformation
Nuria Martinez-Cibrian, Sergi Betriu, Valentin Ortiz-Maldonado, Daniel Estban, Leticia Alserawan, Mercedes Montoro, Anna DD van Muyden, Maike Spoon, Margot J. Pont, Christian Jacques, Julio Delgado
Abstract
Poster presentation on
9 June 2023, 18:00 - 19:00 CET
At the safety and efficacy analysis cut-off date of 9 January 2023, 7 patients diagnosed with rrCLL (including 4 patients with RT) were enrolled in the EUPLAGIA-1 study (n=4 at dose level 1 (DL1); n=3 at dose level 2 (DL2)). All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (DL3)) CAR+ viable T cells.
The initial results from these 7 patients that were eligible for efficacy analysis (cut-off date: 9 January 2023) indicated that a 7-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. Moreover, the initial efficacy results are encouraging with an objective response rate (ORR) of 100% observed. 6 out of 7 patients (86%) reached a complete response (CR) and all Richter’s patients achieved a CR. A duration of response of up to 7.9 months has been reported and follow-up is ongoing. Only 1 patient (DL1) progressed (progressive disease, (PD) after partial response (PR)) and had a CD19-negative relapse with confirmed RT.
In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. None of the patients experienced a CRS higher than grade 2 at both dose levels and no ICANS was reported. No dose limiting toxicities (DLTs) were reported and the majority of grade ≥3 adverse events were hematological. Only one serious adverse event was reported at DL2 with a patient experiencing a CRS grade 2, but the event was resolved after 7 days. Patient recruitment of the study is ongoing.
About point-of-care manufacturing
CellPoint (a Galapagos company) has developed, in a strategic collaboration with Lonza, a novel point-of-care supply model, which is designed to enable clinicians to administer fresh CAR-T cells within 7 days of leukapheresis, without complex logistics or cryopreservation, thereby aiming to address important limitations of current CAR-T treatments. The proprietary platform consists of CellPoint’s end-to-end xCellit workflow management and monitoring software, and Lonza’s Cocoon® Platform, a functionally closed, automated manufacturing platform for cell therapies. This novel point-of-care model is compliant with the EMA and FDA guidance for clinical trials.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5201 in patients with rrCLL and small cell lymphocytic lymphoma (rrSLL), with or without RT. GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as intravenous infusion of a fresh product candidate in a single fixed dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to assess the ORR and the secondary objectives include the analysis of the complete response rate (CRR), duration of response, progression free survival, overall survival, safety pharmacokinetic profile, and feasibility of point-of-care manufacturing.
The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (DL3) CAR+ viable T cells. The study uses a Bayesian Optimal Interval (BOIN) design (n=15 patients) for Phase 1. Following screening and enrolment, patients will receive ibrutinib daily until leukapheresis of mononuclear cells. During GLPG5201 manufacturing, patients receive cyclophosphamide (300 mg/m2/day)/fludarabine (30 mg/m2/day) for 3 days. After a resting period of at least 2 days, GLPG5201 is administered via intravenous infusion. All patients remain hospitalized for at least 7 days and the end-of-study visit is at Week 14 post CAR-T infusion. Phase 1 patient recruitment is ongoing to establish a recommended dose for Phase 2.
About chronic lymphocytic leukemia and small cell lymphocytic lymphoma
Chronic lymphocytic leukemia (CLL) is one of the chronic lymphoproliferative disorders (lymphoid neoplasms). It is characterized by a progressive accumulation of functionally incompetent lymphocytes, which are usually monoclonal in origin. CLL and small cell lymphocytic lymphoma (SLL) are essentially the same type of B-cell non-Hodgkin lymphoma (NHL), with the only difference the location where the primary cancer occurs. CLL affects B-cells in the blood and bone marrow and SLL cancer cells are located in lymph nodes and/or the spleen3. RT is an uncommon clinicopathological condition observed in patients with CLL. It is characterized by the sudden transformation of the CLL into a significantly more aggressive form of large cell lymphoma and occurs in approximately 2-10% of all CLL patients. CLL/SLL usually follows an indolent course and is an incurable disease. Patients who develop relapsed and refractory disease and become resistant to new agents have a dismal prognosis and a high unmet medical need for new therapeutic options such as CAR-T cells. With estimated incidence of 4.7 new cases per 100,000 individuals, CLL/SLL are the most prevalent lymphoid malignancies and are the most common adult leukemias in the US and in Europe 4.
About Galapagos
Galapagos is a fully integrated biotechnology company united around a single purpose: to transform patient outcomes through life-changing science and innovation for more years of life and quality of life. We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs and our first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.
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Galapagos NV
Mon, June 5, 2023 at 10:01 PM GMT+2·8 min read
All 7 out of 7 eligible patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter’s Transformation (RT), responded to treatment (Objective Response Rate of 100%)1
GLPG5201 showed no cytokine release syndrome (CRS) higher than grade 2, or immune effector cell-associated neurotoxicity syndrome (ICANS)2
A functionally closed, automated manufacturing platform for cell therapies at the point-of-care will be shown at the Galapagos booth A.103 at the EHA 2023 congress
Mechelen, Belgium; 5 June 2023, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will feature the CAR-T point-of-care manufacturing platform and will present previously disclosed initial Phase 1/2 data with CD19 CAR-T candidate, GLPG5201, at the European Hematology Association (EHA) 2023 congress, taking place from 8 June to 11 June 2023 in Frankfurt, Germany.
“Patients who develop rrCLL and become resistant to new agents have a very poor prognosis and a significant high unmet medical need for novel therapeutic options such as CAR-T cell therapy. The previously disclosed initial efficacy, safety and feasibility data from the ongoing EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, manufactured at point-of-care, are encouraging, and we are on track to provide Phase 1 topline results around mid this year,” said Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. “Our innovative approach in CAR-T cell therapy development and manufacturing underscores our commitment to accelerating transformational innovation to address the unmet needs of patients with advanced cancers, and we very much look forward to meeting and connecting with you at our booth.”
Details of the abstract P1399:
Title
Authors
Presentation date/time
Initial Clinical Results of Euplagia-1, a Phase I/II Trial of Point-of-Care
Manufactured GLPG5201 in R/R CLL/SLL with or without Richter's transformation
Nuria Martinez-Cibrian, Sergi Betriu, Valentin Ortiz-Maldonado, Daniel Estban, Leticia Alserawan, Mercedes Montoro, Anna DD van Muyden, Maike Spoon, Margot J. Pont, Christian Jacques, Julio Delgado
Abstract
Poster presentation on
9 June 2023, 18:00 - 19:00 CET
At the safety and efficacy analysis cut-off date of 9 January 2023, 7 patients diagnosed with rrCLL (including 4 patients with RT) were enrolled in the EUPLAGIA-1 study (n=4 at dose level 1 (DL1); n=3 at dose level 2 (DL2)). All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (DL3)) CAR+ viable T cells.
The initial results from these 7 patients that were eligible for efficacy analysis (cut-off date: 9 January 2023) indicated that a 7-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. Moreover, the initial efficacy results are encouraging with an objective response rate (ORR) of 100% observed. 6 out of 7 patients (86%) reached a complete response (CR) and all Richter’s patients achieved a CR. A duration of response of up to 7.9 months has been reported and follow-up is ongoing. Only 1 patient (DL1) progressed (progressive disease, (PD) after partial response (PR)) and had a CD19-negative relapse with confirmed RT.
In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. None of the patients experienced a CRS higher than grade 2 at both dose levels and no ICANS was reported. No dose limiting toxicities (DLTs) were reported and the majority of grade ≥3 adverse events were hematological. Only one serious adverse event was reported at DL2 with a patient experiencing a CRS grade 2, but the event was resolved after 7 days. Patient recruitment of the study is ongoing.
About point-of-care manufacturing
CellPoint (a Galapagos company) has developed, in a strategic collaboration with Lonza, a novel point-of-care supply model, which is designed to enable clinicians to administer fresh CAR-T cells within 7 days of leukapheresis, without complex logistics or cryopreservation, thereby aiming to address important limitations of current CAR-T treatments. The proprietary platform consists of CellPoint’s end-to-end xCellit workflow management and monitoring software, and Lonza’s Cocoon® Platform, a functionally closed, automated manufacturing platform for cell therapies. This novel point-of-care model is compliant with the EMA and FDA guidance for clinical trials.
About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5201 in patients with rrCLL and small cell lymphocytic lymphoma (rrSLL), with or without RT. GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as intravenous infusion of a fresh product candidate in a single fixed dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to assess the ORR and the secondary objectives include the analysis of the complete response rate (CRR), duration of response, progression free survival, overall survival, safety pharmacokinetic profile, and feasibility of point-of-care manufacturing.
The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (DL3) CAR+ viable T cells. The study uses a Bayesian Optimal Interval (BOIN) design (n=15 patients) for Phase 1. Following screening and enrolment, patients will receive ibrutinib daily until leukapheresis of mononuclear cells. During GLPG5201 manufacturing, patients receive cyclophosphamide (300 mg/m2/day)/fludarabine (30 mg/m2/day) for 3 days. After a resting period of at least 2 days, GLPG5201 is administered via intravenous infusion. All patients remain hospitalized for at least 7 days and the end-of-study visit is at Week 14 post CAR-T infusion. Phase 1 patient recruitment is ongoing to establish a recommended dose for Phase 2.
About chronic lymphocytic leukemia and small cell lymphocytic lymphoma
Chronic lymphocytic leukemia (CLL) is one of the chronic lymphoproliferative disorders (lymphoid neoplasms). It is characterized by a progressive accumulation of functionally incompetent lymphocytes, which are usually monoclonal in origin. CLL and small cell lymphocytic lymphoma (SLL) are essentially the same type of B-cell non-Hodgkin lymphoma (NHL), with the only difference the location where the primary cancer occurs. CLL affects B-cells in the blood and bone marrow and SLL cancer cells are located in lymph nodes and/or the spleen3. RT is an uncommon clinicopathological condition observed in patients with CLL. It is characterized by the sudden transformation of the CLL into a significantly more aggressive form of large cell lymphoma and occurs in approximately 2-10% of all CLL patients. CLL/SLL usually follows an indolent course and is an incurable disease. Patients who develop relapsed and refractory disease and become resistant to new agents have a dismal prognosis and a high unmet medical need for new therapeutic options such as CAR-T cells. With estimated incidence of 4.7 new cases per 100,000 individuals, CLL/SLL are the most prevalent lymphoid malignancies and are the most common adult leukemias in the US and in Europe 4.
About Galapagos
Galapagos is a fully integrated biotechnology company united around a single purpose: to transform patient outcomes through life-changing science and innovation for more years of life and quality of life. We focus on the key therapeutic areas of immunology and oncology, where we have developed a deep scientific expertise in multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs and our first medicine for rheumatoid arthritis and ulcerative colitis is available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.
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Re: Galapagos - GLPG
Galapagos toont CAR-T data op EHA-congres
Door ABM Financial News op 5 juni 2023 22:23
ABM FN-Dow Jones) Galapagos zal het CAR-T point-of-care productieplatform en de eerder bekendgemaakte eerste fase 1/2-data met CD19 CAR-T-kandidaat, GLPG5201 presenteren op het European Hematology Association (EHA) 2023 congres, dat plaatsvindt van 8 tot 11 juni 2023 in Frankfurt in Duitsland. Dit meldde het biotechbedrijf maandagavond.
"Patiënten die rrCLL ontwikkelen en resistent worden tegen nieuwe middelen, hebben een zeer slechte prognose en een grote onvervulde medische behoefte aan nieuwe therapeutische opties zoals CAR-T-celtherapie. De eerder bekendgemaakte eerste data over de werkzaamheid, veiligheid en haalbaarheid van de lopende EUPLAGIA-1 studie met onze CD19 CAR-T-kandidaat, GLPG5201, point-of-care vervaardigd, zijn bemoedigend, en we zitten op schema om rond het midden van dit jaar fase 1-topline resultaten mee te delen", aldus Jeevan Shetty, Head of Clinical Development Oncology bij Galapagos.
Galapagos nam 7 patiënten op in de studie. De eerste werkzaamheidsresultaten zijn "bemoedigend met een objectief responspercentage (ORR) van 100 procent", aldus Galapagos. Van de 7 patiënten bereikten er 6 "een complete respons", volgens het bedrijf.
Bron: ABM Financial News
Door ABM Financial News op 5 juni 2023 22:23
ABM FN-Dow Jones) Galapagos zal het CAR-T point-of-care productieplatform en de eerder bekendgemaakte eerste fase 1/2-data met CD19 CAR-T-kandidaat, GLPG5201 presenteren op het European Hematology Association (EHA) 2023 congres, dat plaatsvindt van 8 tot 11 juni 2023 in Frankfurt in Duitsland. Dit meldde het biotechbedrijf maandagavond.
"Patiënten die rrCLL ontwikkelen en resistent worden tegen nieuwe middelen, hebben een zeer slechte prognose en een grote onvervulde medische behoefte aan nieuwe therapeutische opties zoals CAR-T-celtherapie. De eerder bekendgemaakte eerste data over de werkzaamheid, veiligheid en haalbaarheid van de lopende EUPLAGIA-1 studie met onze CD19 CAR-T-kandidaat, GLPG5201, point-of-care vervaardigd, zijn bemoedigend, en we zitten op schema om rond het midden van dit jaar fase 1-topline resultaten mee te delen", aldus Jeevan Shetty, Head of Clinical Development Oncology bij Galapagos.
Galapagos nam 7 patiënten op in de studie. De eerste werkzaamheidsresultaten zijn "bemoedigend met een objectief responspercentage (ORR) van 100 procent", aldus Galapagos. Van de 7 patiënten bereikten er 6 "een complete respons", volgens het bedrijf.
Bron: ABM Financial News
Re: Galapagos - GLPG
Galapagos toont CAR-T point-of-care productie en eerste fase 1/2 CLL-data met CD19 CAR-T kandidaat, GLPG5201, op het EHA 2023 congres
05 JUN 2023 22:01 CEST
https://live.euronext.com/nl/product/eq ... e-12114531
05 JUN 2023 22:01 CEST
https://live.euronext.com/nl/product/eq ... e-12114531
Re: Galapagos - GLPG
EcoR1 Capital, LLC ownership in GLPG / Galapagos NV - ADR
2023-06-07 - EcoR1 Capital, LLC has filed an SC 13G form with the Securities and Exchange Commission (SEC) disclosing ownership of 6,505,890 shares of Galapagos NV - ADR (US:GLPG). This represents 9.9 percent ownership of the company. In their previous filing dated 2023-02-14 , EcoR1 Capital, LLC had reported owning 4,442,352 shares, indicating an increase of 46.45 percent.
Institutional Ownership: 13D/G Filings
2023-06-07 2023-06-07 13G 4,442,352 6,505,890 46.45 9.90 47.76
2023-02-14 2023-02-14 13G/A 3,407,246 4,442,352 30.38 6.70 28.85
2022-02-03 2022-02-03 13G 3,407,246 5.20
EcoR1 bezit nu ook al 9.90%, samen met Gilead (25.35%), Van Herk Investments (7.03%) en FMR (5.92%) bezitten de 4 grootste al 48.2%
BVF INC/IL 03/31/2023 2,165,109
STONEPINE CAPITAL MANAGEMENT, LLC 03/31/2023 782,289
POINT72 ASSET MANAGEMENT, L.P. 03/31/2023 715,600
PRIMECAP MANAGEMENT CO/CA/ 03/31/2023 657,377
BLACKROCK INC. 03/31/2023 479,373
CITADEL ADVISORS LLC 03/31/2023 453,118
FINEPOINT CAPITAL LP 03/31/2023 444,659
WELLINGTON MANAGEMENT GROUP LLP 03/31/2023 415,615
PROSIGHT MANAGEMENT, LP 03/31/2023 375,500
RENAISSANCE TECHNOLOGIES LLC 03/31/2023 358,400
LOGOS GLOBAL MANAGEMENT LP 03/31/2023 350,000
MILLENNIUM MANAGEMENT LLC 03/31/2023 349,695
HUDSON BAY CAPITAL MANAGEMENT LP 03/31/2023 332,500
SEGALL BRYANT & HAMILL, LLC 03/31/2023 299,391
DEUTSCHE BANK AG\ 03/31/2023 294,207
NEWTYN MANAGEMENT, LLC 03/31/2023 268,282
GREENLIGHT CAPITAL INC 03/31/2023 151,368
NORGES BANK 12/31/2022 120,000
MORGAN STANLEY 03/31/2023 106,991
683 CAPITAL MANAGEMENT, LLC 03/31/2023 93,971
ALPHACENTRIC ADVISORS LLC 03/31/2023 92,000
TANG CAPITAL MANAGEMENT LLC 03/31/2023 89,650
DAFNA CAPITAL MANAGEMENT LLC 03/31/2023 52,675
SUVRETTA CAPITAL MANAGEMENT, LLC 03/31/2023 47,200
ALPS ADVISORS INC 03/31/2023 43,055
GOLDMAN SACHS GROUP INC 03/31/2023 42,445
UBS OCONNOR LLC 03/31/2023 41,250
SUSQUEHANNA INTERNATIONAL GROUP, LLP 03/31/2023 40,474
2023-06-07 - EcoR1 Capital, LLC has filed an SC 13G form with the Securities and Exchange Commission (SEC) disclosing ownership of 6,505,890 shares of Galapagos NV - ADR (US:GLPG). This represents 9.9 percent ownership of the company. In their previous filing dated 2023-02-14 , EcoR1 Capital, LLC had reported owning 4,442,352 shares, indicating an increase of 46.45 percent.
Institutional Ownership: 13D/G Filings
2023-06-07 2023-06-07 13G 4,442,352 6,505,890 46.45 9.90 47.76
2023-02-14 2023-02-14 13G/A 3,407,246 4,442,352 30.38 6.70 28.85
2022-02-03 2022-02-03 13G 3,407,246 5.20
EcoR1 bezit nu ook al 9.90%, samen met Gilead (25.35%), Van Herk Investments (7.03%) en FMR (5.92%) bezitten de 4 grootste al 48.2%
BVF INC/IL 03/31/2023 2,165,109
STONEPINE CAPITAL MANAGEMENT, LLC 03/31/2023 782,289
POINT72 ASSET MANAGEMENT, L.P. 03/31/2023 715,600
PRIMECAP MANAGEMENT CO/CA/ 03/31/2023 657,377
BLACKROCK INC. 03/31/2023 479,373
CITADEL ADVISORS LLC 03/31/2023 453,118
FINEPOINT CAPITAL LP 03/31/2023 444,659
WELLINGTON MANAGEMENT GROUP LLP 03/31/2023 415,615
PROSIGHT MANAGEMENT, LP 03/31/2023 375,500
RENAISSANCE TECHNOLOGIES LLC 03/31/2023 358,400
LOGOS GLOBAL MANAGEMENT LP 03/31/2023 350,000
MILLENNIUM MANAGEMENT LLC 03/31/2023 349,695
HUDSON BAY CAPITAL MANAGEMENT LP 03/31/2023 332,500
SEGALL BRYANT & HAMILL, LLC 03/31/2023 299,391
DEUTSCHE BANK AG\ 03/31/2023 294,207
NEWTYN MANAGEMENT, LLC 03/31/2023 268,282
GREENLIGHT CAPITAL INC 03/31/2023 151,368
NORGES BANK 12/31/2022 120,000
MORGAN STANLEY 03/31/2023 106,991
683 CAPITAL MANAGEMENT, LLC 03/31/2023 93,971
ALPHACENTRIC ADVISORS LLC 03/31/2023 92,000
TANG CAPITAL MANAGEMENT LLC 03/31/2023 89,650
DAFNA CAPITAL MANAGEMENT LLC 03/31/2023 52,675
SUVRETTA CAPITAL MANAGEMENT, LLC 03/31/2023 47,200
ALPS ADVISORS INC 03/31/2023 43,055
GOLDMAN SACHS GROUP INC 03/31/2023 42,445
UBS OCONNOR LLC 03/31/2023 41,250
SUSQUEHANNA INTERNATIONAL GROUP, LLP 03/31/2023 40,474
-
Blackadder
- Premiummember
- Berichten: 5160
- Lid geworden op: 04 mei 2012 17:19
- waarderingen: 2604
Re: Galapagos - GLPG
KBC Securities schreef een rapport bij elkaar. De biotechgroep betrad de CAR-T-markt met
een alternatief point of care productiemodel met de Cocoon, dat schaal- en leveringsuitdagingen van
autologe CAR-Ts moet oplossen. En dat is voor KBCS een goede strategie is voor snelle proof of concept
en vroege fase 1/2-data in NHL en CLL. Ook de immunologiefranchise heeft nog altijd waarde, maar dan
met iets bescheidener verwachtingen. Een herwerking van het model levert een koersdoelverlaging op
van 60 naar 55 euro, maar omdat de CAR-T-inspanningen zinvol zijn stijgt het advies van “Houden” naar
“Opbouwen”
Bron: Bolero
een alternatief point of care productiemodel met de Cocoon, dat schaal- en leveringsuitdagingen van
autologe CAR-Ts moet oplossen. En dat is voor KBCS een goede strategie is voor snelle proof of concept
en vroege fase 1/2-data in NHL en CLL. Ook de immunologiefranchise heeft nog altijd waarde, maar dan
met iets bescheidener verwachtingen. Een herwerking van het model levert een koersdoelverlaging op
van 60 naar 55 euro, maar omdat de CAR-T-inspanningen zinvol zijn stijgt het advies van “Houden” naar
“Opbouwen”
Bron: Bolero
-
Blackadder
- Premiummember
- Berichten: 5160
- Lid geworden op: 04 mei 2012 17:19
- waarderingen: 2604
Re: Galapagos - GLPG
Galapagos: De biotechgroep zal dit jaar mogelijk zo’n 450 miljoen euro cash verstoken, terwijl de groep
zelf gisteren de lat op 380 Ă 420 miljoen euro behield. De verstook lag in de eerste jaarhelft dan ook
boven de lat en er werden recent meerdere Fase II/III studies opgestart. De groep verlaagde de
omzetverwachting voor Jyseleca van 140 Ă 160 miljoen euro naar 100 Ă 120 miljoen euro, nog altijd 9%
onder de analistenverwachting. Hoewel de piekverkoopprognose van 400 miljoen (nog) niet werd
verlaagd, verwacht KBCS dat dit op een later tijdstip zal gebeuren. Onze analist kijkt vooruit naar
bijkomende data van de fase 1/2 CAR-T studies, ergens rond het jaareinde. Geen impact op
“Opbouwen”-advies en 55 euro koersdoel.
zelf gisteren de lat op 380 Ă 420 miljoen euro behield. De verstook lag in de eerste jaarhelft dan ook
boven de lat en er werden recent meerdere Fase II/III studies opgestart. De groep verlaagde de
omzetverwachting voor Jyseleca van 140 Ă 160 miljoen euro naar 100 Ă 120 miljoen euro, nog altijd 9%
onder de analistenverwachting. Hoewel de piekverkoopprognose van 400 miljoen (nog) niet werd
verlaagd, verwacht KBCS dat dit op een later tijdstip zal gebeuren. Onze analist kijkt vooruit naar
bijkomende data van de fase 1/2 CAR-T studies, ergens rond het jaareinde. Geen impact op
“Opbouwen”-advies en 55 euro koersdoel.
Re: Galapagos - GLPG
https://www.tijd.be/ondernemen/farma-bi ... 84694.html
De enorme cashberg leverde in het eerste halfjaar 33 miljoen euro intresten op. Dat is niet veel minder dan de 54 miljoen halfjaaromzet euro die Jyseleca opleverde. Opmerkelijk is dat Galapagos winstgevend was en in de eerste zes maanden 28 miljoen euro winst draaide, grotendeels het gevolg van de boekhoudkundige afwikkeling van de miljardendeal met Gilead enkele jaren terug.
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De enorme cashberg leverde in het eerste halfjaar 33 miljoen euro intresten op. Dat is niet veel minder dan de 54 miljoen halfjaaromzet euro die Jyseleca opleverde. Opmerkelijk is dat Galapagos winstgevend was en in de eerste zes maanden 28 miljoen euro winst draaide, grotendeels het gevolg van de boekhoudkundige afwikkeling van de miljardendeal met Gilead enkele jaren terug.Re: Galapagos - GLPG
Galapagos kondigt de start aan van een fase 2-studie met de selectieve TYK2-remmer GLPG3667 bij patiënten met actieve systemische lupus erythematodes
28 AUG 2023 22:01 CEST
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28 AUG 2023 22:01 CEST
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Re: Galapagos - GLPG
Citi ziet evaluatie Galapagos-middel Jyseleca resulteren in verkoop
Op de Citi Biopharma Conference had analist Peter Verdult een gesprek met Thad Hudson, de nieuwe CFO/COO van Galapagos. Hij vertelde dat het bedrijf een zeer grondige evaluatie aan het doorvoeren is en dat daarbij alle opties worden bekeken.
Verdult verwacht dat Galapagos zich volledig zal gaan toeleggen op celtherapie in hematologische en auto-immuunaandoeningen. Daarbij kan zowel worden samengewerkt met Gilead als onderzoek worden verricht op eigen kracht.
Hij denkt dat de begin augustus aangekondigde evaluatie van het reumamiddel Jyseleca en het commercieel apparaat in de EU in het vierde kwartaal of het eerste van 2024 in een desinvestering zal resulteren. Daarbij zou ook het fase 2-onderzoek in dermatomysositis de deur kunnen uitgaan. Hij gaat ervan uit dat R&D-inspanningen buiten celtherapie zullen worden stopgezet.
De bedoeling van dat alles is de cash burn fors te verminderen, terwijl dankzij de omgeving van stijgende rentetarieven de financiële positie van Galapagos - dat 4 miljard euro in kas heeft - zal worden versterkt.
De Citi-analist hanteert een 'neutral'-rating (houden) en een koersdoel van 41 euro voor Galapagos.
Bron: De Tijd
Op de Citi Biopharma Conference had analist Peter Verdult een gesprek met Thad Hudson, de nieuwe CFO/COO van Galapagos. Hij vertelde dat het bedrijf een zeer grondige evaluatie aan het doorvoeren is en dat daarbij alle opties worden bekeken.
Verdult verwacht dat Galapagos zich volledig zal gaan toeleggen op celtherapie in hematologische en auto-immuunaandoeningen. Daarbij kan zowel worden samengewerkt met Gilead als onderzoek worden verricht op eigen kracht.
Hij denkt dat de begin augustus aangekondigde evaluatie van het reumamiddel Jyseleca en het commercieel apparaat in de EU in het vierde kwartaal of het eerste van 2024 in een desinvestering zal resulteren. Daarbij zou ook het fase 2-onderzoek in dermatomysositis de deur kunnen uitgaan. Hij gaat ervan uit dat R&D-inspanningen buiten celtherapie zullen worden stopgezet.
De bedoeling van dat alles is de cash burn fors te verminderen, terwijl dankzij de omgeving van stijgende rentetarieven de financiële positie van Galapagos - dat 4 miljard euro in kas heeft - zal worden versterkt.
De Citi-analist hanteert een 'neutral'-rating (houden) en een koersdoel van 41 euro voor Galapagos.
Bron: De Tijd
Re: Galapagos - GLPG
Galapagos heeft Simon Sturge benoemd als niet-uitvoerend bestuurder. Dat maakte het bedrijf dinsdag bekend.
Sturge vervang Mary Kerr, die maandag terugtrad.
Sturge was CEO van biotechbedrijven Kymab en Celltech Biologics en bekleedde leidinggevende posities van Merck KGaA en Boehringer Ingelheim.
Sturge vervang Mary Kerr, die maandag terugtrad.
Sturge was CEO van biotechbedrijven Kymab en Celltech Biologics en bekleedde leidinggevende posities van Merck KGaA en Boehringer Ingelheim.
