Geron Oral Presentation at Upcoming ASCO Annual Meeting to Highlight Meaningful Continuous Transfusion Independence Observed in Imetelstat-Treated Lower Risk MDS Patients in IMerge Phase 3

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[{"type":"text","content":"\n- Data support NDA submission which is on track for June 2023 to support potential U.S. commercial launch in first half of 2024\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGeron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced acceptance of its IMerge Phase 3 abstract as an oral presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. This abstract describes statistically significant positive efficacy and safety data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS). These data support the Company’s planned New Drug Application (NDA) submission to the U.S. FDA which is on track for June 2023, to support a potential U.S. commercial launch of imetelstat in lower risk MDS in the first half of 2024.\n\n\n“We believe that imetelstat has the potential to be practice-changing in lower risk MDS based on the unprecedented durability of transfusion independence, as well as broad activity across a range of disease subtypes in IMerge Phase 3,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “We are thrilled that these data will be featured in an oral presentation at ASCO, where we will have a significant medical affairs presence to bring more awareness to the continuing unmet need in lower risk MDS and very much look forward to meaningful engagement with the medical community.”\n\n\nDetails for the oral presentation are as follows:\n\n\nAbstract #: 7004\n\n\nTitle: IMerge: “Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA).”\n\n\nDate/Time: June 2, 2023 at 2:12 p.m. CT\n\n\nSession: “Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant”\n\n\nPresenter: Amer Methqal Zeidan, Yale School of Medicine\n\n\nThe abstract recaps top-line results from IMerge Phase 3 with a data cut-off of October 2022. As reported in January 2023, the primary endpoint of 8-week transfusion independence (TI) was met with high statistical significance (P","length":3087,"tagName":"div"}]

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