Geron Shares Plunge 12% After Halting Phase 3 Myelofibrosis Drug Trial

Geron Corporation (NASDAQ: GERN) shares fell as much as 12% on Wednesday after the company announced it would discontinue its Phase 3 IMpactMF clinical trial. The study was evaluating the drug candidate imetelstat as a treatment for patients with a specific type of myelofibrosis, a serious bone marrow cancer.

Trial Halted on Efficacy Concerns

The decision to halt the late-stage trial was based on a recommendation from an independent Data Monitoring Committee (DMC), according to a company statement. The DMC concluded that the trial was unlikely to meet its primary endpoint of improving overall survival for patients.

"Given the recommendation from the DMC, we believe discontinuing our Phase 3 IMpactMF trial at this time is the right course of action," stated Joseph E. Eid, Geron's Chief Medical Officer. The company noted that no new safety signals were observed that would change the known safety profile of imetelstat.

About the IMpactMF Study

The IMpactMF trial was a critical part of Geron's development pipeline, focused on a difficult-to-treat patient population. The discontinuation represents a significant setback for the imetelstat program in this indication.

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• Patient Population: The trial enrolled 327 patients with intermediate-2 or high-risk myelofibrosis who were relapsed or refractory to treatment with a JAK inhibitor.
• Trial Design: The study was an open-label, controlled trial that compared imetelstat administered intravenously every three weeks against the best available therapy.

Geron said it plans to conduct a detailed analysis of the trial data and will share the findings with the scientific community at a later date.

Company Focuses on Commercial Operations

Despite the clinical trial failure, Geron's management sought to reassure investors by highlighting the company's other priorities. President and CEO Harout Semerjian pointed to the company's "growing commercial business, a strong financial foundation, and a clear strategy to pursue innovation."

The company stated it remains committed to growing the U.S. market for its approved drug, RYTELO, and expanding access for eligible patients outside the U.S. This pivot emphasizes Geron's reliance on its existing commercial revenue streams following the setback in its clinical pipeline.