FDA Events for Galapagos (GLPG)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Galapagos (GLPG).
Over the past two years, Galapagos has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GLPG5101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GLPG5101 - FDA Regulatory Timeline and Events
GLPG5101 is a drug developed by Galapagos for the following indication: In patients with relapsed/refractory chronic lymphocytic leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GLPG5101
- Announced Date:
- June 12, 2025
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV will present new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 30th European Hematology Association (EHA) Congress.
AI Summary
Galapagos NV announced that it will present new data from its ongoing ATALANTA-1 Phase 1/2 study at the 30th European Hematology Association (EHA) Congress. The study focuses on its investigational CD19 CAR T-cell therapy, GLPG5101, tested in patients with relapsed or refractory non-Hodgkin’s lymphoma. Early findings reveal a low rate of high-grade toxicities and an impressive 95% infusion rate of fresh, stem-like early memory CAR-T cells. The decentralized manufacturing platform allows for a median vein-to-vein time of seven days, reducing the need for cryopreservation and avoiding cytotoxic bridging therapy. This rapid delivery approach has led to a notably low patient attrition rate of only 5%, compared to industry benchmarks. The data highlight promising safety outcomes and suggest that the approach could broaden access to effective CAR-T treatments for high unmet medical need patients.
Read Announcement- Drug:
- GLPG5101
- Announced Date:
- May 14, 2025
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV announced that new data from our ongoing ATALANTA-1 Phase 1/2 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) have been accepted for oral presentations at the 2025 European Hematology Association (EHA) Congress taking place June 12-15, 2025, in Milan, Italy, and the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland the following week.
AI Summary
Galapagos NV announced that new data from its ongoing ATALANTA-1 Phase 1/2 study of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) have been accepted for oral presentations at two key international conferences. The data will showcase safety and long-term follow-up results in various lymphoma subtypes, including diffuse large B-cell, mantle cell, follicular, and marginal zone lymphomas.
The findings will be presented at the 2025 European Hematology Association (EHA) Congress in Milan, Italy, from June 12-15, 2025, followed by a presentation at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 18, 2025. These presentations underline Galapagos NV’s commitment to improving patient outcomes with GLPG5101 as a novel CD19 CAR T-cell therapy that uses fresh, stem-like early memory cells.
Read Announcement- Drug:
- GLPG5101
- Announced Date:
- December 7, 2024
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV announced additional data from the ongoing Phase 1/2 ATALANTA-1 study of its CD19 CAR T-cell therapy, GLPG5101.
AI Summary
Galapagos NV announced new data from its ongoing Phase 1/2 ATALANTA-1 study of the CD19 CAR T-cell therapy, GLPG5101, in patients with relapsed/refractory non-Hodgkin lymphoma. The study showed high antitumor activity and a promising safety profile across different lymphoma subtypes. Almost all patients received an infusion of fresh, fit, stem-like, early memory CD19 CAR T-cells, with a median vein-to-vein time of just seven days. This fast turnaround eliminates the need for cryopreservation and bridging therapy. The findings were shared in an oral presentation at the American Society of Hematology meeting, underlining the potential of Galapagos’ decentralized manufacturing platform to deliver treatments quickly. Faster production and delivery of high-quality cells could improve scheduling flexibility and lead to better patient outcomes in treating aggressive lymphomas.
Read Announcement- Drug:
- GLPG5101
- Announced Date:
- October 1, 2024
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Excellos Inc announced that it has been selected to manufacture Galapagos' CAR-T cell therapy candidate, GLPG5101, for its recently FDA cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S.
AI Summary
Excellos Inc. has been chosen to manufacture Galapagos’ CAR-T cell therapy candidate, GLPG5101, for the FDA-cleared ATALANTA-1 clinical study. The study focuses on treating patients with relapsed/refractory non-Hodgkin lymphoma in the U.S. This important collaboration marks a key milestone in using a decentralized manufacturing approach to produce CAR-T therapies. Excellos, operating from its purpose-built facility in downtown San Diego, follows a strict assessment process to gain this role and will handle the end-to-end manufacturing process. The innovative decentralized platform is designed to overcome common challenges in CAR-T cell therapy production, aiming to provide efficient, fresh, and fit cells for treatment with a median vein-to-vein time of seven days.
This partnership with Galapagos underscores growing efforts to improve access and effectiveness of advanced cancer therapies across the country.
Read Announcement- Drug:
- GLPG5101
- Announced Date:
- August 23, 2024
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV announced that the U.S. Food and Drug Administration (FDA) has cleared Galapagos' Investigational New Drug (IND) application for ATALANTA-1, a Phase 1/2 multicenter study evaluating the feasibility, safety, and efficacy of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL).
AI Summary
Galapagos NV announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATALANTA-1. This Phase 1/2 multicenter study will evaluate GLPG5101, an autologous CD19 CAR-T cell therapy, in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). The trial will first test the safety and preliminary efficacy of GLPG5101 to determine the best dose for the next phase. Researchers will also look at the effectiveness of a decentralized manufacturing process designed to deliver fresh, fit cells within an average of seven days from vein to vein.
This clearance marks an important step forward for Galapagos’ cell therapy program aimed at providing faster and more flexible treatment options for patients battling rapidly progressing non-Hodgkin lymphoma.
Read Announcement- Drug:
- GLPG5101
- Announced Date:
- June 14, 2024
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV announced that it will present encouraging new data from the ongoing Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma (R/R NHL) at the annual European Hematology Association (EHA) 2024 Hybrid Congress. Galapagos' product candidate GLPG5101 is produced using the company's innovative, decentralized T-cell manufacturing platform.
AI Summary
Galapagos NV announced that it will present promising new data from its ongoing Phase 1/2 ATALANTA-1 study of the CD19 CAR-T candidate, GLPG5101, at the European Hematology Association 2024 Hybrid Congress. The study focuses on patients with relapsed/refractory non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. The updated data, presented by Dr. Marie José Kersten, highlights encouraging safety profiles and high complete response rates in a heavily pretreated patient population. Notably, GLPG5101 is produced using Galapagos’ innovative, decentralized T-cell manufacturing platform, which enabled administration of the fresh product with a median vein-to-vein time of just seven days, eliminating the need for bridging therapy. This rapid process, along with the improved T-cell phenotypes observed during production, demonstrates the potential of the platform to deliver high-quality CAR-T therapies to patients swiftly and effectively.
Read Announcement
Galapagos FDA Events - Frequently Asked Questions
As of now, Galapagos (GLPG) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Galapagos (GLPG) has reported FDA regulatory activity for GLPG5101.
The most recent FDA-related event for Galapagos occurred on June 12, 2025, involving GLPG5101. The update was categorized as "New Data," with the company reporting: "Galapagos NV will present new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 30th European Hematology Association (EHA) Congress."
Currently, Galapagos has one therapy (GLPG5101) targeting the following condition: In patients with relapsed/refractory chronic lymphocytic leukemia.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GLPG) was last updated on 7/12/2025 by MarketBeat.com Staff
