KALV Regulatory

KalVista Pharmaceuticals Announces Maintenance of Orphan Designation for Sebetralstat in European Union

Published August 11, 2025 at 11:00 AM

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) confirmed maintenance of orphan designation for sebetralstat, underscoring the critical unmet need that sebetralstat addresses in the European Union (EU). Sebetralstat, a novel, oral plasma kallikrein inhibitor, has received a positive CHMP opinion for the treatment of acute attacks of

Related Questions

How will the maintenance of orphan designation affect KalVista's projected revenue and cash flow forecasts? What is the expected timeline for further regulatory milestones (e.g., EMA approval, FDA filing) after this orphan designation confirmation? How does the market size for acute attacks of the targeted condition in the EU compare to other indications KalVista is pursuing? What pricing and reimbursement strategies is KalVista planning for sebetralstat in the EU, and how might they impact profitability? Will the orphan designation enable any additional incentives (e.g., tax credits, market exclusivity) that could enhance the company's valuation? How does sebetralstat's efficacy and safety profile compare to existing therapies and other pipeline competitors? What are the potential risks or uncertainties that could delay or jeopardize the eventual commercialization of sebetralstat? How might this regulatory update influence institutional and analyst sentiment toward KalVista's stock? Is there any indication that the CHMP positive opinion will expedite the drug's launch timeline in the EU? What impact could this development have on KalVista's partnership or licensing opportunities with larger pharmaceutical firms?