Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, with disease modification potential for myeloid hematologic malignancies. Geron is committed to improving and extending the lives of patients by changing the course of these diseases by targeting telomerase. We are conducting two ongoing Phase 3 clinical trials that are intended to enable registration: (i) IMerge Phase 3 in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS, and (ii) IMpactMF in Intermediate-2 or High-risk myelofibrosis, or refractory MF.
IMerge Phase 3 is fully enrolled, and we expect top-line results in early January 2023. We plan to submit a New Drug Application (NDA) with the FDA, and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), for imetelstat in lower risk MDS in the first half of 2023 and 2nd half of 2023, respectively. We expect that potential commercial launch of imetelstat in lower risk MDS in the United States could occur in the first half of 2024 and for Europe in the second half of 2024.
Imetelstat has been granted Fast Track designations by the United States Food and Drug Administration (FDA) for the treatment of patients with transfusion-dependent anemia due to lower risk MDS, who do not have a deletion 5q chromosomal abnormality, also known as non-del(5q), and who are refractory or resistant to treatment with an erythropoiesis stimulating agent, or ESA, and for the treatment of patients with relapsed/refractory MF.
Imetelstat has also been granted orphan drug designations by the FDA and by the European Commission for the European Medicines Agency for the treatment of MDS and MF. In 2021, imetelstat was granted an Innovation Passport designation by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), with the objective of reducing the time to market for innovative medicines.