Geron: FDA ODAC votes 12-2 in favor of imetelstat's benefit/risk for LR-MDS

GERON CORP

ODAC voted 12 to 2 that imetelstat's clinical benefit/risk profile is favorable for TD anemia in LR-MDS.
PDUFA target action date for imetelstat NDA is June 16, 2024.
IMerge Phase 3 met primary endpoint: ≥8-week RBC-TI significantly higher vs placebo (p<0.001).
28% (imetelstat) vs 3% (placebo) achieved ≥24-week RBC-TI; median duration for responders was 80 weeks.
Common Grade 3-4 adverse events: thrombocytopenia (62%) and neutropenia (68%); generally manageable.

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