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Rytelo (imetelstat)

Geron Corporation · $GERN
Priority Review Fast Track Orphan Drug sBLA
PDUFA Date
April 15, 2026
Date Status
18d ago (past)
Review Type
Priority (6 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: April 14, 2026
FDA Approved on 2026-04-14 (NDA217779). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217779

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$1.58 +10.49%
+$0.15 today
Day: $1.52 – $1.60
Market Cap
N/A
Shares out: 640.90M
Float: 510.80M
52-Week Range
$1.04
$2.01
Current price is at 56% of 52-week range
Avg Volume
18.37M
Beta
0.67
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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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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