Geron Corporation (NASDAQ:GERN) shares plunged on Wednesday after the company halted its late-stage cancer program.
Independent Panel Recommends Study Discontinuation
The hematology biopharmaceutical company decided to discontinue the Phase 3 IMpactMF trial evaluating imetelstat in JAK inhibitor-treated relapsed/refractory myelofibrosis.
IMpactMF evaluated 327 patients with intermediate-2 or high-risk myelofibrosis who were relapsed or refractory to a JAK inhibitor.
The trial was designed to evaluate imetelstat as a potential improvement in overall survival compared to best available therapy. Patients in the imetelstat arm received 9.4 mg/kg IV every three weeks.
The decision was based on a recommendation from the independent Data Monitoring Committee, or DMC.
The independent DMC advised Geron that the trial was unlikely to meet its primary endpoint of overall survival. There were no new safety signals observed in the trial that change the known safety profile of imetelstat or require additional safety monitoring.
A detailed analysis of the data will be conducted, and study findings will be shared with the scientific community at a future date.
“Given the recommendation from the DMC, we believe discontinuing our Phase3 IMpactMF trial at this time is the right course of action,” Geron Chief Medical Officer Joseph Eid said in a statement.
Leadership Emphasizes Commercial Growth And Innovation Strategy
“As we fully analyze the data from the IMpactMF trial, we remain committed to growing RYTELO demand in the U.S. and broadening access to eligible LR-MDS patients outside the U.S.,” said Geron CEO Harout Semerjian. “We have a growing commercial business, a strong financial foundation, and a clear strategy to pursue innovation to create long-term value and build a leading hematology company.”
GERN Price Action: Geron shares were down 14.64% at $0.98 on Wednesday. The stock was trading at a new 52-week low, according to Benzinga Pro data.
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