---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-21-047970"
form_type: "8-K"
ticker: "KALV"
cik: "0001348911"
company_name: "KalVista Pharmaceuticals, Inc."
filed_at: "2021-09-15T23:59:59+00:00"
generated_at: "2026-06-29T03:27:40.512553+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on KalVista's Phase 2 KVD824 trial for HAE prophylaxis

## Summary
- FDA removed clinical hold on Phase 2 KOMPLETE trial of KVD824 for oral prophylactic treatment of hereditary angioedema.
- Clinical hold lifted after FDA review of KalVista's responses on certain preclinical studies of KVD824.
- Protocol refinements made; company working to resume study activities as soon as possible.

## SEC filing metadata
- accession: 0001564590-21-047970
- form_type: 8-K
- ticker: KALV
- cik: 0001348911
- company_name: KalVista Pharmaceuticals, Inc.
- filed_at: 2021-09-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1348911/000156459021047970/0001564590-21-047970-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1348911/000156459021047970/kalv-8k_20210914.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-21-047970
- JSON: https://secwatch.observer/filing/0001564590-21-047970.json
- Plain text: https://secwatch.observer/filing/0001564590-21-047970.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.