Geron Reports EMA Validation Of Marketing Authorization Application For Imetelstat

(RTTNews) - Geron Corporation (GERN) said the European Medicines Agency has validated the Marketing Authorization Application for imetelstat in the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes. The MAA was submitted earlier in the month and is now under regulatory review by the CHMP. Review of the MAA is expected to be approximately 14 months, the company said.

Geron noted that the MAA validation follows the acceptance by the FDA of a New Drug Application, which was assigned a PDUFA action date of June 16, 2024.

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