Geron announces EMA validation for imetelstat MAA

Geron announced that the European Medicines Agency, or EMA, has validated the marketing authorization application, or MAA, for imetelstat, an investigational telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes, or MDS. The MAA was submitted earlier this month and is now under regulatory review by the European Committee for Medicinal Products for Human Use, or 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.