Galapagos(GLPG)

Search documents
Galapagos(GLPG) - 2024 Q3 - Quarterly Report
2024-10-30 22:08
EXHIBIT 99.1 Galapagos Reports Third Quarter 2024 Financial Results and Provides Business Update We are advancing our pipeline and accelerating innovation through focused execution of our Forward, Faster strategy. We are committed to addressing the high unmet needs of patients through a growing cell therapy and small molecule pipeline with breakthrough potential. This includes more than 20 programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs in onco ...
Galapagos Reports Third Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-10-30 20:01
We are advancing our pipeline and accelerating innovation through focused execution of our Forward, Faster strategy. We are committed to addressing the high unmet needs of patients through a growing cell therapy and small molecule pipeline with breakthrough potential. This includes more than 20 programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs in oncology and immunology. We achieved a major regulatory milestone with the FDA clearance of the Inves ...
Galapagos welcomes Oleg Nodelman to its Board of Directors to support strategic growth
GlobeNewswire News Room· 2024-10-07 05:00
Board Appointment - Oleg Nodelman appointed as Non-Executive Non-Independent Director to Galapagos' Board of Directors, effective October 7, 2024 [1] - Mr Nodelman replaces Dan G Baker who stepped down on October 6, 2024 [2] - Mr Nodelman is the Founder and Portfolio Manager of EcoR1 Capital LLC, a biotech-focused investment advisory firm [3] - Mr Nodelman holds a Bachelor of Science in Foreign Service with a concentration in Science and Technology from Georgetown University [4] Strategic Impact - The addition of Mr Nodelman marks an important step in Galapagos' ongoing efforts to engage with shareholders and continue to execute on the Forward, Faster strategy to accelerate innovation and create near-and long-term value [2] - Mr Nodelman's deep expertise in biotech and shared goals of unlocking further value for Galapagos will be instrumental in helping the company execute its near- and long-term strategy and deliver superior results for patients, shareholders, employees, and customers [3] - Mr Nodelman brings a wealth of experience in driving shareholder value, strategic transformations, and long-term growth initiatives [3] Company Overview - Galapagos is a biotechnology company with operations in Europe and the US dedicated to transforming patient outcomes through life-changing science and innovation [6] - The company focuses on high unmet medical needs and synergizes compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology [6] - Galapagos has capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, and the financial strength to invest strategically for the long-term [6]
Galapagos receives transparency notification from EcoR1 Capital
GlobeNewswire News Room· 2024-09-16 20:01
Mechelen, Belgium; 16 September 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from EcoR1 Capital LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 13 September 2024 on behalf of Mr. Oleg Nodelman and EcoR1 Capital LLC, who notified that EcoR1 Capital LLC holds 6,713,553 of Galapagos' voting rights, consisting of 839,388 ordinary shares and 5,874,165 American Depository Receipts, further ...
Galapagos (GLPG) Up on FDA Nod to Begin Phase I/II Lymphoma Study
ZACKS· 2024-08-23 12:45
Shares of Galapagos NV (GLPG) , a clinical-stage company, are rising in the premarket hours on Aug 23, after the FDA cleared its investigational new drug application to begin an early to mid-stage study of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate, which is administered as a single, fixed, intravenous dose. It has been developed utilizing Galapagos' proprietary decentralized cell therapy manufacturing pla ...
Galapagos receives transparency notification from FMR LLC
GlobeNewswire News Room· 2024-08-20 20:01
Mechelen, Belgium; 20 August 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from FMR LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 16 August 2024 from FMR LLC, who notified that it holds 3,696,750 of Galapagos' voting rights, consisting of 3,693,550 ordinary shares and 3,200 equivalent financial instruments. FMR LLC controls investment funds Fidelity Management & Research Company LLC ...
Galapagos(GLPG) - 2024 Q2 - Earnings Call Transcript
2024-08-02 17:25
Galapagos NV (NASDAQ:GLPG) Q2 2024 Earnings Conference Call August 2, 2024 8:00 AM ET Company Participants Sofie Van Gijsel - Head of Investor Relations Paul Stoffels - Chair of the Board and Chief Executive Officer Thad Huston - Chief Financial Officer and Chief Operating Officer Jeevan Shetty - Head of Development Oncology Conference Call Participants Brian Abrahams - RBC Capital Markets Philip Nadeau - TD Cowen Judah Frommer - Morgan Stanley Jason Gerberry - Bank of America Sean McCutcheon - Raymond Jame ...
BridGene Biosciences Expands Strategic Collaboration with Galapagos to Develop Selective Oral SMARCA2 PROTAC in Precision Oncology
Prnewswire· 2024-08-01 20:01
BridGene Eligible to Receive Up to $159 Million in Total Payments SAN JOSE, Calif., Aug. 1, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditionally "hard-to-drug" targets, today announced an expansion to its strategic collaboration and licensing agreement with Galapagos NV (Euronext: GLPG) (NASDAQ: GLPG). This new collaboration builds upon the partnership initiated in January 2024, focusing on the discovery of a highly selective oral SMARCA2 small ...
Galapagos reports half-year 2024 financial results and provides second quarter business update
GlobeNewswire News Room· 2024-08-01 20:01
Executing on our Forward, Faster strategy with strong progress in a pivotal year, focused on delivering regulatory and clinical milestones, expanding our cell therapy manufacturing capabilities, and advancing our early-stage programs. Submitted IND application to FDA for our Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101 in R/R NHL. Submitted CTA to EMA for our Phase 2 study of GLPG5201 in R/R CLL with or without RT. IND filing for our Phase 1/2 EUPLAGIA-1 study of CD19 CAR-T candidate GLPG520 ...
Galapagos presents encouraging new data for CD19 CAR-T candidate GLPG5101 in non-Hodgkin lymphoma at EHA 2024
Newsfilter· 2024-06-14 20:01
GLPG5101 Clinical Trial Data - GLPG5101, a CD19 CAR-T candidate, showed promising results in the Phase 1/2 ATALANTA-1 study for relapsed/refractory non-Hodgkin lymphoma (R/R NHL) [1] - As of December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2) received GLPG5101 with a median vein-to-vein time of seven days [3] - In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment (ORR 87.5%), with 12 achieving a complete response (CRR 75%) [16] - In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), with all responders achieving a complete response (CRR 93.3%) [16] - High ORR and CRR were observed across different lymphoma types: DLBCL (ORR 78%, CRR 56%), FL/MZL (ORR and CRR 94%), and MCL (ORR and CRR 100%) [16] - Durable responses were observed, with 71% of Phase 1 patients and 100% of Phase 2 patients maintaining responses at data cut-off [16] GLPG5101 Safety Profile - GLPG5101 demonstrated an encouraging safety profile, with most treatment-emergent adverse events (TEAEs) being Grade 1 or 2 [16] - Two cases of Grade 3 cytokine release syndrome (CRS) were observed in Phase 1, and one case of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in Phase 2 [16] - No unexpected safety findings were observed as of the data cut-off date [10] Galapagos' T-Cell Manufacturing Platform - The company's decentralized T-cell manufacturing platform enables a median vein-to-vein time of seven days, eliminating the need for bridging therapy [2] - The platform consists of xCellit® workflow management software, Lonza's Cocoon® automated manufacturing system, and proprietary quality control testing [6] - The final CAR-T product showed a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells compared to starting material, indicating improved cell quality during manufacturing [2] Non-Hodgkin Lymphoma Overview - Non-Hodgkin lymphoma is a cancer originating from lymphocytes, with B-cell lymphoma accounting for about 85% of cases in the US [5] - The disease can be aggressive (fast-growing) or indolent (slow-growing), with prognosis and treatment depending on the stage and type [5] Presentation Details - The new data will be presented at the European Hematology Association (EHA) 2024 Hybrid Congress by Marie José Kersten, M.D. [18] - The presentation will include updated safety and efficacy data for GLPG5101 in patients with DLBCL, FL, MZL, and MCL, as well as durability and cellular kinetics data [10]