earnings
confidence high
sentiment positive
materiality 0.85
KalVista Q1: EKTERLY approved in US/UK; 460 patient start forms; positive CHMP opinion
KalVista Pharmaceuticals, Inc.
2026-Q1 EPS reported
-$1.12
revenue$1,400,000
- EKTERLY (sebetralstat) FDA approved July 7, 2025; UK MHRA authorized same month; positive CHMP opinion; EU decision expected Oct 2025.
- Received 460 patient start forms through August 29, 2025 (nearly 5% of US HAE patients).
- Net product revenue $1.4M from US sales; R&D expenses $15.2M (down 43% YoY); SG&A $44.7M (up 154% YoY due to commercialization).
- Cash and marketable securities $191.5M as of July 31, 2025; runway into 2027.
- Orphan designation maintained in EU; 10 years market exclusivity; one of only two HAE medicines with orphan status.