regulatory
confidence high
sentiment neutral
materiality 0.65
Geron's imetelstat MAA for lower-risk MDS validated by EMA for review
GERON CORP
- MAA for imetelstat in transfusion-dependent anemia with lower-risk MDS validated by EMA.
- Review by CHMP under centralized procedure covering all 27 EU states plus Iceland, Norway, Liechtenstein.
- Expected review period of approximately 14 months.
- Submission made in September 2023; now under regulatory review.