KalVista Pharmaceuticals provided an operational update and released financial results for the fiscal quarter ended July 31, 2025.
EKTERLY (sebetralstat) received FDA approval for the treatment of acute attacks of hereditary angioedema.
The company reported $191.5 million in cash, cash equivalents, and marketable securities as of July 31, 2025.
EKTERLY FDA Approval
EKTERLY is now approved in the US and UK, providing an oral on-demand therapy for acute attacks of hereditary angioedema.
European Medicines Agency Approval
The European Medicines Agency recommended approval of sebetralstat and confirmed maintenance of orphan designation, decision expected in October 2025.
Financial Performance
KalVista Pharmaceuticals recognized net product revenue of $1.4 million for the three months ended July 31, 2025, with a strong cash position of $191.5 million.
- KalVista Pharmaceuticals saw a significant response to the FDA approval of EKTERLY, with 460 patient start forms received through August.
- The company is well-positioned to maximize the global opportunity for EKTERLY as a foundational therapy for hereditary angioedema patients.
The recent approvals and financial results showcase KalVista Pharmaceuticals' growth potential in the HAE treatment market, supported by a strong balance sheet and positive reception for EKTERLY.