Clinical-stage biotech Geron Corporation ( NASDAQ: GERN ) jumped ~64% pre-market Wednesday after announcing topline data from its IMerge Phase 3 clinical trial for its only candidate imetelstat, in lower-risk myelodysplastic syndromes (MDS) patients.
The 178-subject global trial involved lower-risk MDS patients who were relapsed, refractory, or ineligible for erythropoiesis-stimulating agents (ESAs).
The company said that IMerge met its primary efficacy endpoint of 8-week transfusion independence (TI) and the key secondary endpoint of 24-week TI, indicating highly statistically significant and clinically meaningful benefit for imetelstat compared to placebo.
Geron ( GERN ) added that IMerge's treatment-emergent adverse events (TEAEs) were found to be in line with prior clinical findings, and no new safety signals were detected.
The overall discontinuation rates stood at 77.1% vs. 76.3%, and discontinuation rates related to adverse events were found to be 16.1% and 0.0% between the imetelstat and placebo groups, respectively.
The company expects to submit marketing applications for the candidate in the U.S. and Europe in mid-2023 and H2 2023, expecting the commercial launch of the therapy for lower-risk MDS in H1 2024 and by the end of next year, respectively.
Geron ( GERN ) shares surged in the after-hours on Tuesday after the company announced the upcoming readout.
For further details see:
Geron adds 64% on late-stage data for blood disorder candidate