Geron: FDA Assigns PDUFA Action Date For NDA For Imetelstat

(RTTNews) - Geron Corp. (GERN) announced the FDA has assigned a standard review and a Prescription Drug User Fee Act action date of June 16, 2024 for New Drug Application for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes.

Also, the FDA informed the company that it is currently planning to hold an advisory committee meeting as part of the NDA review.

John Scarlett, Geron's CEO, said: "With the PDUFA date now set, we continue to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval."

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