---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-155885"
form_type: "8-K"
ticker: "KALV"
cik: "0001348911"
company_name: "KalVista Pharmaceuticals, Inc."
filed_at: "2025-07-07T23:59:59+00:00"
generated_at: "2026-05-18T09:15:37.494550+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# KalVista receives FDA approval for EKTERLY (sebetralstat), first oral on-demand HAE treatment

## Summary
- FDA approved EKTERLY for acute attacks of hereditary angioedema in patients 12+ years; first oral on-demand therapy.
- Phase 3 KONFIDENT trial (136 patients, 20 countries) showed faster symptom relief vs placebo; published in NEJM.
- KONFIDENT-S open-label extension: median 10 minutes to treat attacks after onset; 1.3 hours to symptom relief for laryngeal/abdominal/breakthrough attacks.
- Launching immediately; prescriptions available today; KalVista Cares patient support program launched.
- CEO Ben Palleiko says EKTERLY has potential to become foundational HAE treatment; conference call at 8:30am ET.

## SEC filing metadata
- accession: 0001193125-25-155885
- form_type: 8-K
- ticker: KALV
- cik: 0001348911
- company_name: KalVista Pharmaceuticals, Inc.
- filed_at: 2025-07-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1348911/000119312525155885/0001193125-25-155885-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1348911/000119312525155885/d98157d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-155885
- JSON: https://secwatch.observer/filing/0001193125-25-155885.json
- Plain text: https://secwatch.observer/filing/0001193125-25-155885.txt

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