Geron submits NDA for imetelstat to FDA, sees submission of MA to EU in 2H23

Geron announced the submission to the United States Food and Drug Administration of a New Drug Application for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes MDS who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents ESAs . “This pioneering achievement to submit the first New Drug Application to the FDA for a telomerase inhibitor reflects the dedication, commitment and teamwork of so many people who believed targeting telomerase could make a significant difference for patients,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are deeply committed to addressing the unmet needs for lower risk MDS patients, who often suffer from transfusion-dependent anemia.” The NDA submission is based on results from IMerge Phase 3, in which the primary endpoint of 8-week transfusion independence was significantly higher with imetelstat vs. placebo with median TI duration approaching one year for imetelstat 8-week TI responders. As allowed under imetelstat’s Fast Track designation in lower risk MDS, Geron has requested that the FDA grant Priority Review of the NDA. Under standard practice, Geron expects FDA communication in 60 days whether the NDA was accepted for review and the timeline of such review. Additionally, based on IMerge Phase 3, Geron expects to submit a Marketing Authorization Application in the EU in the second half of 2023.