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donidalorsen

KalVista Pharmaceuticals · $KALV
Standard Review Advisory Committee
AdCom Date
August 20, 2026
Time Remaining
129 days
Review Type
Standard (10 mo)
85%
Baseline PoA
NDA standard review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NGM

Updated just now · 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

FDA Pulmonary-Allergy Drugs Advisory Committee meeting for donidalorsen NDA. AdCom expected ~2 months before October 2026 PDUFA date. ZENITH Phase 3 data to be reviewed.
⚠️ 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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