Geron Corporation GERN submitted a marketing application with the FDA seeking approval for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents.
The 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, with median TI duration approaching one year for imetelstat 8-week TI responders.
Mean hemoglobin levels in imetelstat-treated patients increased significantly (P<0.001) over time compared to placebo patients.
As allowed under imetelstat's Fast Track designation, Geron has requested that the FDA grant a Priority Review. Additionally, based on IMerge Phase 3, Geron expects to submit a European marketing application in 2H of 2023.
Most recently, Geron announced that the first patient had been dosed in the investigator-led Phase 2 IMpress trial evaluating imetelstat, in patients with acute myeloid leukemia or higher risk myelodysplastic syndromes who are relapsed/refractory/intolerant to hypomethylating agents.
Price Action: GERN shares are trading 5.67% higher at $3.17 on the last check Tuesday.
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