The US stock market is witnessing a notable surge in the value of Galapagos NV (NASDAQ: GLPG) shares. The stock increased by 6.55% as of the most recent pre-market check, trading at $30.25. This was on top of a previous session advance of 9.66%, which ended at $28.39. This encouraging pattern comes after the firm gained a significant regulatory approval last week, which gave its stock performance even more traction.
Galapagos Won FDA Approval for ATALANTA-1 Study
The FDA in the United States has accepted Galapagos NV’s application for an Investigational New Drug (IND) for ATALANTA-1, the company said recently. With this permission, the business may move forward with a Phase 1/2 multicenter research assessing GLPG5101, a product that uses autologous CD19 CAR-T cells for cell therapy. The goal of the trial is to evaluate GLPG5101’s viability, safety, and effectiveness in treating patients with relapsed or resistant non-Hodgkin lymphoma (R/R NHL).
Innovative CAR-T Therapy Manufacturing
Utilizing Galapagos’ decentralized cell therapy manufacturing infrastructure, GLPG5101 is a breakthrough in CAR-T cell therapy. This technology can generate and deliver new, healthy cells in as little as seven days from vein to vein in the median vein.
The primary objective of the ATALANTA-1 study’s Phase 1 phase is to assess GLPG5011’s safety and preliminary effectiveness in order to establish the appropriate dosage for Phase 2 of the trial. Assessing the decentralized manufacturing approach’s viability and effectiveness are secondary goals.
Positive Outlook of GLPG for Phase 2 and Upward
Evaluation of GLPG5101’s objective response rate, full response rate, response duration, progression-free survival, overall survival, and safety will be the main goals of the Phase 2 trial. Additionally, the possibility of decentralized production will be further investigated in this study.
Every patient who signs up for the research will be followed up with for a full year. Promising early findings from the current Phase 1/2 ATALANTA-1 research in Europe support GLPG5101’s potential to be a successful therapy for R/R NHL.
With the latest FDA clearance, Galapagos NV has achieved a major step in commercializing its ground-breaking CD19 CAR-T cell treatment in the United States. With its sophisticated workflow management software, automated production, and unique quality control techniques, the Galapagos platform has the potential to revolutionize the cell therapy industry.
