Geron Announces EMA Validation of Marketing Authorization Application for Imetelstat for the Treatment of Lower Risk MDS

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for imetelstat, a first-in-class investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS). The MAA was submitted earlier this month and is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 EU member states, Iceland, Norway and Liechtenstein. Review of the MAA is expected to be approximately 14 months.

“The EMA validation of the marketing authorization application for imetelstat brings us one step closer to potentially offering this first-in-class therapeutic to lower risk MDS patients in the EU suffering from anemia,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “Based on the clinical profile of imetelstat to date, we are optimistic about its potential to become a standard of care and address longstanding unmet needs of lower risk MDS patients.”

The MAA 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