US FDA staff flags concerns about Geron's anemia treatment

Geron Corporation is a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies. The Company is engaged in the development of therapeutic products for oncology. Its lead indication for imetelstat is in Low or Intermediate-1 risk myelodysplastic syndromes. It is developing imetelstat for the treatment of several myeloid hematologic malignancies, including a Phase 3 clinical trial, named IMpactMF, in relapsed/refractory myelofibrosis (MF) with overall survival as the primary endpoint, that is enrolling patients. It is also conducting a Phase 1 combination therapy clinical trial, named IMproveMF, in first-line Intermediate-1, Intermediate-2 or High-Risk myelofibrosis, or frontline MF, that is enrolling patients and imetelstat is being studied in an investigator-led Phase 2 clinical trial, named IMpress, in Intermediate-2 or High-Risk myelodysplastic syndromes and acute myeloid leukemia.