---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-043949"
form_type: "8-K"
ticker: "GERN"
cik: "0000886744"
company_name: "GERON CORP"
filed_at: "2023-08-22T23:59:59+00:00"
generated_at: "2026-06-11T05:54:28.164411+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-23-043949
- form_type: 8-K
- ticker: GERN
- cik: 0000886744
- company_name: GERON CORP
- filed_at: 2023-08-22T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/886744/000095017023043949/0000950170-23-043949-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/886744/000095017023043949/gern-20230821.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-043949
- JSON: https://secwatch.observer/filing/0000950170-23-043949.json
- Plain text: https://secwatch.observer/filing/0000950170-23-043949.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.