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Rytelo (imetelstat)

Geron Corporation · $GERN

Priority Review Fast Track Orphan Drug sBLA

PDUFA Date

April 15, 2026

Time Remaining

22 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical sBLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Myelodysplastic syndromes (MDS) — low to intermediate risk

Key Notes

Supplemental BLA for MDS label expansion. First telomerase inhibitor. Rytelo generated $183.6M FY2025 net product revenue; 2026 guidance $220M–$240M. IMpactMF Phase 3 trial in myelofibrosis ongoing — interim OS analysis expected 2H 2026.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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