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Monday, 10/02/2023 11:54:34 AM

Monday, October 02, 2023 11:54:34 AM

Post# of 7715
>>On September 29, 2023, Geron Corporation (“Geron” or the “Company”) announced that its Marketing Authorization Application (“MAA”) for the use of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes has been validated for review by the European Medicines Agency (“EMA”). The MAA was submitted in September 2023, 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.
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