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donidalorsen

KalVista Pharmaceuticals · $KALV
Priority Review Orphan Drug Fast Track NDA
PDUFA Date
October 20, 2026
Time Remaining
154 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 32m ago · Data: FMP
Current Price
$26.76 +124.31%
+$14.83 today
Day: $26.72 – $26.77
Market Cap
N/A
52-Week Range
$9.83
$26.85
Current price is at 99% of 52-week range
⚠️ 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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