Briefly SBIR (NIH) involved from 1994-1998, in 2023Geron (NASDAQ:GERN) is now usefully understood a late-stage clinical biopharmaceutical company early focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, with disease modification potential for myeloid hematologic malignancies. Committed to improving and extending patient lives by targeting telomerase - changing the course of these diseases, the firm conducted two Phase 3 clinical trials 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 with top-line top-line results expected in early January 2023. A New Drug Application (NDA) will be submitted to 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. Potential commercial launch of imetelstat in US for lower risk MDS 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 US 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. 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 Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA), with the objective of reducing the time to market for innovative medicines.
