---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-031475"
form_type: "8-K"
ticker: "GERN"
cik: "0000886744"
company_name: "GERON CORP"
filed_at: "2024-03-14T23:59:59+00:00"
generated_at: "2026-06-04T21:57:04.015441+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Geron: FDA ODAC votes 12-2 in favor of imetelstat's benefit/risk for LR-MDS

## Summary
- ODAC voted 12 to 2 that imetelstat's clinical benefit/risk profile is favorable for TD anemia in LR-MDS.
- PDUFA target action date for imetelstat NDA is June 16, 2024.
- IMerge Phase 3 met primary endpoint: ≥8-week RBC-TI significantly higher vs placebo (p<0.001).
- 28% (imetelstat) vs 3% (placebo) achieved ≥24-week RBC-TI; median duration for responders was 80 weeks.
- Common Grade 3-4 adverse events: thrombocytopenia (62%) and neutropenia (68%); generally manageable.

## SEC filing metadata
- accession: 0000950170-24-031475
- form_type: 8-K
- ticker: GERN
- cik: 0000886744
- company_name: GERON CORP
- filed_at: 2024-03-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/0000950170-24-031475-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/gern-20240314.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-031475
- JSON: https://secwatch.observer/filing/0000950170-24-031475.json
- Plain text: https://secwatch.observer/filing/0000950170-24-031475.txt

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