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donidalorsen

KalVista Pharmaceuticals · $KALV
Priority Review Orphan Drug Fast Track NDA
PDUFA Date
October 20, 2026
Time Remaining
190 days
Review Type
Priority (6 mo)
93%
Baseline PoA
Orphan/rare disease designation approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NGM

Updated 1m ago · Data: FMP
Current Price
$19.39 +83.97%
+$8.85 today
Day: $19.14 – $19.98
Market Cap
N/A
Shares out: 51.22M
Float: 29.56M
52-Week Range
$9.83
$21.30
Current price is at 83% of 52-week range
Avg Volume
952K
Beta
-0.40
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

Hereditary angioedema (HAE) — on-demand oral treatment

Key Notes

First oral on-demand treatment for HAE attacks from KalVista's pipeline (distinct from EKTERLY/sebetralstat which launched in July 2025). ZENITH-1 and ZENITH-2 Phase 3 data. Note: EKTERLY (sebetralstat) is KalVista's already-approved HAE drug; donidalorsen is a separate NDA submission.
⚠️ 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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