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donidalorsen

KalVista Pharmaceuticals · $KALV

Priority Review Orphan Drug Fast Track NDA

PDUFA Date

October 20, 2026

Time Remaining

210 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical NDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

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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