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Rytelo (imetelstat (Rytelo) — IMpactMF)

Geron Corporation · $GERN
Standard Review Phase 3 Orphan Drug
Catalyst Date
September 15, 2026
Time Remaining
168 days
Review Type
Standard (10 mo)

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$1.41 -14.55%
$-0.24 today
Day: $1.38 – $1.43
Market Cap
N/A
52-Week Range
$1.04
$2.01
Current price is at 38% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

Indication

Myelofibrosis (MF) — overall survival analysis

Key Notes

IMpactMF Phase 3 interim overall survival (OS) analysis expected H2 2026 (company guidance). Phase 3 trial comparing imetelstat to best available therapy in transfusion-dependent patients with relapsed/refractory myelofibrosis who are JAK inhibitor-intolerant or progressed on JAK inhibitor. Positive OS data would support regulatory filings in myelofibrosis — a large potential new indication for Rytelo alongside its approved MDS indication. Geron MDS sBLA PDUFA April 15, 2026 will be decided before this readout.
⚠️ 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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