Press release
Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the submission to
About this update from Geron Corporation
[{"type":"text","content":" FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGeron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the submission to the United States Food and Drug Administration (FDA) of a New Drug Application (NDA) 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).\n\n\n“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.”\n\n\nThe 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 (P","length":1348,"tagName":"div"}]