Geron receives FDA approval for RYTELO (imetelstat) in lower-risk MDS with transfusion-dependent anemia

GERON CORP

RYTELO approved for low-to-int-1 risk MDS with TD anemia requiring ≥4 RBC units/8 wks who failed/are ineligible for ESAs.
Phase 3 IMerge trial: 8-week RBC-TI 39.8% vs 15.0% placebo (p<0.001); 24-week RBC-TI 28.0% vs 3.3% (p<0.001).
Median RBC-TI duration ~1 year for 8-week responders; ~1.5 years for 24-week responders.
Most common Grade 3/4 adverse reactions: neutropenia (72%) and thrombocytopenia (65%), each lasting median <2 weeks.
Conference call with Geron management scheduled for 8am ET on June 7, 2024 to discuss the approval and launch.

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