Geron:FDA assigns standard review, PDUFA action date June 16 for imetelstat NDA

Geron announced that the United States Food and Drug Administration, FDA, has assigned a standard review and a Prescription Drug User Fee Act, PDUFA, action date of June 16 for Geron’s New Drug Application NDA for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes, MDS . In addition, the FDA informed the Company that it is currently planning to hold an advisory committee meeting as part of the NDA review. “We look forward to working with the FDA to complete the NDA review process on a timely basis,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “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.”