Geron Stock Surges After Encouraging Data From Rare Blood Cancer Trial
Geron Corporation (NASDAQ: 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.
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