- Geron Corporation GERN announced topline results from its IMerge Phase 3 trial of imetelstat, in lower-risk myelodysplastic syndromes (MDS) patients who are relapsed, refractory, or ineligible for erythropoiesis-stimulating agents (ESAs).
- The trial met the primary 8-week transfusion independence (TI) endpoint and key secondary 24-week TI endpoint with statistically significant and clinically meaningful improvements.
- 47 vs. nine patients at eight weeks and 33 vs. two patients at 24 weeks.
- Median TI duration approaching one year for imetelstat 8-week TI responders and 1.5 years for imetelstat 24-week TI responders.
- Mean hemoglobin levels in imetelstat patients increased significantly over time compared to placebo patients. For patients achieving 8-week TI, median increases in hemoglobin were 3.6 g/dL for imetelstat and 0.8 g/dL for placebo.
- Imetelstat patients also experienced a statistically significant and clinically meaningful mean reduction in RBC transfusion units compared to placebo.
- Safety results were consistent with prior imetelstat clinical experience with no new safety signals.
- Geron plans to submit an FDA marketing application in the U.S. in mid-2023 and a European application in the second half of 2023.
- Geron is preparing for an anticipated commercial launch of imetelstat in lower-risk MDS in the first half of 2024 in the U.S. and by the end of 2024 in the EU, assuming regulatory approvals are granted.
- Price Action: GERN shares are up 47.90% at $3.55 during the premarket session on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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