Press release
Geron Corporation Reports Business Highlights and Second Quarter 2023 Financial Results
Submitted U.S. New Drug Application in lower risk MDS in June 2023 Additional data and analyses from IMerge Phase 3 presented at medical meetings further
About this update from Geron Corporation
[{"type":"text","content":"\nSubmitted U.S. New Drug Application in lower risk MDS in June 2023\n\n\nAdditional data and analyses from IMerge Phase 3 presented at medical meetings further strengthen value proposition and differentiation of imetelstat\n\n\nPotential U.S. commercial launch in lower risk MDS expected in first half of 2024\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGeron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported business highlights and financial results for the second quarter of 2023.\n\n\n“We progressed our business significantly this quarter, as we evolve into a commercial company. Most notably, we submitted the first New Drug Application to the FDA for a telomerase inhibitor, a pioneering achievement that reflects our teams’ dedication to ground-breaking and innovative drug development,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “Importantly, new data and analyses from IMerge Phase 3 presented at ASCO and EHA further strengthen the value proposition of imetelstat by highlighting differentiated attributes of the drug, such as unprecedented continuous durable transfusion independence, responses across subgroups, patient-reported outcomes of improved fatigue and strong evidence of disease-modifying activity.”\n\n\nDr. Scarlett also noted, “With approximately $400 million on the balance sheet as of the end of the quarter, we have the financial resources to not only fund a potential successful launch, but also to support the first year of launch.”\n\n\nBusiness Highlights\n\n\n\nSubmitted New Drug Application (NDA) to the FDA based on results from IMerge Phase 3 in lower risk myelodysplastic syndromes (MDS).\n\n\n\nPresented new data and analyses from IMerge Phase 3 at ASCO and EHA reporting robust durability of transfusion independence, evidence of disease-modifying activity and favorable fatigue patient-reported outcomes in imetelstat-treated lower risk MDS patients versus placebo.\n\n\n\nInitiated Expanded Access Protocol (EAP) in June 2023, making imetelstat available to clinicians and patients prior to potential FDA approval.\n\n\n\nAchieved >40% enrollment in IMpactMF, Geron’s Phase 3 trial of imetelstat in patients with myelofibrosis (MF) relapsed/refractory to JAK-i...