This section highlights FDA-related milestones and regulatory updates for drugs developed by Lakefront Biotherapeutics American Depositary Shares (LKFT).
Over the past two years, Lakefront Biotherapeutics American Depositary Shares has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GLPG3667 and GLPG5101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
GLPG3667 FDA Regulatory Events
GLPG3667 is a drug developed by Lakefront Biotherapeutics American Depositary Shares for the following indication: patients with dermatomyositis.
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:
- GLPG3667
- Announced Date:
- December 18, 2025
- Indication:
- patients with dermatomyositis
Announcement
Galapagos NV nnounced the topline results from two Phase 3-enabling studies evaluating the efficacy and safety of GLPG3667, a selective TYK2 inhibitor, in patients with dermatomyositis (DM) (GALARISSO study) and active systemic lupus erythematosus (SLE) (GALACELA study).
AI Summary
Galapagos announced topline results from two Phase 3‑enabling studies of GLPG3667, a selective TYK2 inhibitor. In the GALARISSO dermatomyositis (DM) study, GLPG3667 150 mg once daily (N=21) met the primary endpoint at Week 24 versus placebo (N=19), showing a statistically significant improvement in Total Improvement Score (TIS) (Δ 14.26; p=0.0848, pre‑specified α=0.1). The drug also produced meaningful gains on several secondary measures (TIS20/40/60 and m‑CDASI‑A) and had a favorable safety and tolerability profile over 24 weeks.
In the GALACELA systemic lupus erythematosus (SLE) study, two doses (75 mg, N=59; 150 mg, N=64) did not achieve statistical significance on the primary SRI‑4 dose‑response at Week 32 versus placebo (N=63), though numerical improvements—particularly on skin outcomes—were observed. Safety was consistent with prior studies. Galapagos will evaluate strategic options, including resuming partnering, to accelerate development in DM and explore other severe autoimmune indications; final Week 48 SLE data are expected in Q2 2026.
Read Announcement
GLPG5101 FDA Regulatory Timeline and Events
GLPG5101 is a drug developed by Lakefront Biotherapeutics American Depositary Shares 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:
- August 6, 2025
- Indication:
- In patients with relapsed/refractory chronic lymphocytic leukemia
Announcement
Galapagos NV announced that the United States Food and Drug Administration (FDA) has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL).
AI Summary
Galapagos NV announced that the US FDA granted RMAT designation to GLPG5101, a second-generation anti-CD19/4-1BB CAR-T therapy for relapsed/refractory mantle cell lymphoma. This designation under the 21st Century Cures Act speeds up development of promising cell and gene therapies for serious diseases. GLPG5101 showed strong preliminary data in the ATALANTA-1 trial, with high response rates and a manageable safety profile in patients with B-cell non-Hodgkin lymphoma, including mantle cell lymphoma.
RMAT status allows Galapagos to work closely with the FDA through frequent interactions, priority review, and accelerated approval based on intermediate endpoints. Benefits include Fast Track and Breakthrough Therapy advantages, rolling submissions, and early discussions on study endpoints. Galapagos plans to share updated ATALANTA-1 data at an upcoming medical conference as it advances this treatment option for patients facing limited choices.
Read Announcement- 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
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