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donidalorsen

KalVista Pharmaceuticals · $KALV

Standard Review Advisory Committee

PDUFA Date

August 20, 2026

Time Remaining

149 days

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical NDA/BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

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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