Geron stock tumbles after halting Phase 3 trial

Investing.com -- Geron Corporation (NASDAQ: GERN) shares fell 12% Wednesday after the company announced it would discontinue its Phase 3 IMpactMF trial evaluating imetelstat in JAK inhibitor relapsed/refractory myelofibrosis.

The decision followed a recommendation from the independent Data Monitoring Committee (DMC), which advised that the trial was unlikely to meet its primary endpoint of overall survival.

The IMpactMF trial evaluated 327 patients with intermediate-2 or high-risk myelofibrosis who were relapsed or refractory to a JAK inhibitor. Patients were randomized 2:1 in an open label, controlled trial comparing imetelstat at 9.4 mg/kg IV every three weeks against best available therapy.

The company said no new safety signals were observed in the trial that would change the known safety profile of imetelstat or require additional safety monitoring. Geron plans to conduct a detailed analysis of the data and share study findings with the scientific community at a future date.

"Given the recommendation from the DMC, we believe discontinuing our Phase 3 IMpactMF trial at this time is the right course of action," said Joseph E. Eid, Chief Medical Officer of Geron.

Despite the trial discontinuation, Geron said it remains committed to growing RYTELO demand in the U.S. and broadening access to eligible LR-MDS patients outside the U.S. Harout Semerjian, President and Chief Executive Officer, said the company has a growing commercial business, a strong financial foundation, and a clear strategy to pursue innovation.

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