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 ...

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 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 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 ...

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 ...

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]

Mechelen, Belgium; 16 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,614,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 16 May 2024, the Board of Directors of Galapagos approved "Subscription Right Plan 2024 BE", intended for members of personnel of the company, "Subscription Right Plan 2024 RMV," intended for the e ...

Mechelen, Belgium; 16 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 1,614,000 subscription rights under new subscription right plans for the benefit of certain members of the personnel of the company and its subsidiaries. On 16 May 2024, the Board of Directors of Galapagos approved "Subscription Right Plan 2024 BE", intended for members of personnel of the company, "Subscription Right Plan 2024 RMV," intended for the e ...

"Our collaboration with Blood Centers of America marks a major milestone for Galapagos' U.S. expansion by establishing centers for support of our pivotal studies, with the potential to be used for commercial introduction. Working with BCA's extensive nationwide network allows us to efficiently scale up decentralized CAR-T therapy manufacturing across the U.S., while their established infrastructure helps us harmonize operations and access apheresis capacity," said Dr. Paul Stoffels1, CEO and Chairman of the ...

Operator In the past, you have mentioned that you see the CLL program as the most likely program to get fast proof of concept and get to the market. Can you provide your vision on the current progress of the program and the Thank you very much for the question. First of all, I'll speak to the program, and then secondly to the data from Bristol-Myers Squibb. With regard to our -- CLL high-risk CLL and Richter's transformation studies. The expansion part of the study is to be initiated imminently. We've had v ...