regulatory
confidence high
sentiment neutral
materiality 0.75
FDA schedules advisory committee meeting for Geron's imetelstat NDA on March 14, 2024
GERON CORP
- FDA's Oncologic Drugs Advisory Committee will review imetelstat for transfusion-dependent anemia in lower-risk MDS on March 14, 2024.
- Meeting is scheduled from 9:30 a.m. to 3:00 p.m. ET, and will be open to the public.
- PDUFA action date for the NDA remains June 16, 2024.
- Federal Register notice published January 30, 2024 provides details of the advisory committee meeting.