FDA accepts Geron's NDA for imetelstat in lower-risk MDS; PDUFA date June 16, 2024

GERON CORP

FDA accepted NDA for imetelstat for transfusion-dependent anemia in lower-risk MDS.
Standard review assigned; PDUFA action date set for June 16, 2024.
FDA currently plans to hold an advisory committee meeting as part of the review.

item 8.01

GERON CORP filing history →

Source: SEC EDGAR

accession 0000950170-23-043949

view filing index on sec.gov

view primary document

Machine-readable: JSON · Markdown · Plain text

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.