Galapagos shares rise after FDA approves trial (NASDAQ:GLPG)

Galapagos (NASDAQ: GLPG) shares rose in Europe on Friday after the U.S. Food and Drug Administration (FDA) gave the green light to a Phase 1/2 trial for its CAR-T cell therapy GLPG5101 to treat non-Hodgkin lymphoma, a cancer of the white blood cells.

The multicenter project called ATALANTA-1 The trial is already underway in Europe and its initial data indicate the potential of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (NHL), according to the Belgian biotech company. With FDA approval, the company can expand the trial in the US.

Phase 1 of ATALANTA-1 will evaluate the efficacy and safety of GLPG5101 to help researchers determine the recommended dose for Phase 2.

In Phase 2, the primary objective is objective response rate, a critical parameter for cancer drugs. Secondary objectives include overall survival, the “gold standard” for measuring the clinical benefit of cancer therapy.