Geron’s NDA Filing Accepted by the FDA

Geron Corporation (Nasdaq: GERN) has announced that the FDA has accepted its New Drug Application filing forImetelstat, its first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).

Geron expects to submit a Marketing Authorization Application in the European Union in Q4 2023.

John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer, said, “The FDA’s acceptance of our New Drug Application is an important landmark along our steadfast journey to bring telomerase inhibition with imetelstat to the market. We look forward to continuing our collaboration with the FDA toward the goal of bringing imetelstat to the many patients for whom we believe this treatment could make a significant difference.”

Highlights

The NDA submission is based on results from IMerge Phase 3, in which the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo.

Mean hemoglobin levels in imetelstat-treated patients increased significantly over time compared to placebo patients.

Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.

Patient-reported outcomes (PRO) data reported a sustained meaningful improvement in fatigue for imetelstat-treated patients vs. placebo.

The FDA has up to 74 days from the NDA submission date to notify Geron of the Prescription Drug User Fee Act (PDUFA) action date for the NDA

About Geron

Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. Geron currently has two Phase 3 pivotal clinical trials underway evaluating imetelstat in lower risk myelodysplastic syndromes (LR MDS), and in relapsed/refractory myelofibrosis (MF). To learn more, visit www.geron.com or follow us on LinkedIn.

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Geron’s NDA Filing Accepted by the FDA

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