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Geron Corporation - Investors & MediaResearch & Development Telomerase Imetelstat PublicationsPatients Clinical Trials IMerge Phase 3 IMpactMF IMProveMF IMPress TELOMERE Hematologic Malignancies Expanded Access PolicyInvestors & Media About Overview History Management Board of Directors Partnering Our Culture ContactPipeline R & D PipelinePartnering Corporate Development Scientific CollaboratorsPipeline R & D PipelineCareers OpportunitiesInvestors & Media Press Releases Events Stock Information Corporate Governance SEC Filings Analyst Coverage FAQs Investors & Media Geron Logo close navigation Home Open Research & Development Telomerase Inhibition Imetelstat Publications Clinical Trials Healthcare Professionals Open Pipeline R & D PipelineOpen Patients Clinical Trials IMerge Phase 3 IMpactMF IMproveMF IMpress TELOMERE Hematologic Malignancies Expanded Access PolicyOpen Partnering Corporate Development Scientific CollaboratorsOpen Investors & Media Open About Overview HistoryLeadership Board of DirectorsPartneringCulture History Contact Open Careers OpportunitiesTerms of Use Privacy Policy Cookie PolicyCorporate profile Geron is working to change the course of hematologic malignancies Geron is a late-stage biopharmaceutical company with a mission to extend and enhance the lives of patients living with hematologic malignancies. Our first-in-class telomerase inhibitor, imetelstat, has demonstrated strong evidence of disease modification in Phase 2 trials. Geron is focused on the development and potential commercialization of imetelstat and currently has two Phase 3 clinical trials ongoing: IMerge in lower risk myelodysplastic syndromes (LR MDS) and IMpactMF in relapsed/refractory myelofibrosis (MF). These indications represent potential multi-billion-dollar market opportunities. We have an experienced and knowledgeable management team and employee base to execute and deliver on our mission. 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 United States Food and Drug Administration (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 as early as the first half of 2024 and for Europe in the second half of 2024. Imetelstat has been granted Fast Track designations by the 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 EMA 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.Press releases More Upcoming events More Stipulation of Settlement and Notice of Pendency of Settlement of Derivative LitigationNotification Stipulation of Settlement and Notice of Pendency of Settlement of Derivative Litigation Corporate presentation Annual reports and proxy statement Fiscal Year 2023 Annual Report and Proxy Statement Stock information Contact information CG Capital 877-889-1972 investor@geron.comReceive email alerts Geron investor relations [email protected] Print Page RSS Feeds E-mail Alerts Explore Research & Development Pipeline Partnering Patients Browse Latest updates Publications Corporate profile Press releases Events Learn About Leadership Culture History Follow linkedin Connect Careers Locations ContactsTerms of Use Privacy Policy Cookie Policy Copyright © 2022 Geron. All rights reserved Powered By Q4 Inc. 5.83.0.2 (opens in new window) Explore Research & Development Pipeline Partnering Patients Learn About Leadership Culture History Connect Careers Locations Contacts Browse Latest updates Publications Corporate profile Press releases Events Follow linkedinTerms of Use Privacy Policy Cookie Policy Copyright © 2022 Geron. All rights reserved Powered By Q4 Inc. 5.83.0.2 (opens in new...