Press release
KalVista Pharmaceuticals Highlights Strategic Plans for Coming Fiscal Year
- Regulatory filings planned for US, EU, UK and Japan to enable multiple 2025 commercial launches – - Development strategy refined for oral Factor XIIa
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Regulatory filings planned for US, EU, UK and Japan to enable multiple 2025 commercial launches –\n\n\n- Development strategy refined for oral Factor XIIa program –\n\n\n- Organizational focus to drive results and set path to positive cash flow –\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced its strategic plans for fiscal year 2025, beginning May 1, including for sebetralstat, the Company’s investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).\n\n\n“2024 has been an exciting and busy year for KalVista, as we achieved key milestones with our positive phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista. “For the coming fiscal year, we have set a high bar as we finalize multiple regulatory filings for sebetralstat and plan for rapid commercialization upon approval. Given the scale of that opportunity, we will focus our resources on activities that support the launch, enabling sebetralstat to become the leading on-demand therapy for all people living with HAE and allowing us to work towards positive cash flow within the first few years of commercialization.”\n\n\nFiscal Year 2025 Strategic Plans:\n\n\nRegulatory filings and commercial partners for sebetralstat, to support global launch plans\n\n\n\nNew Drug Application submission to US FDA planned for June 2024\n\n\n\nMarket Authorization Application submissions to both European Medicines Agency and UK MHRA planned for Q3 2024\n\n\n\nJNDA submission to Japanese Pharmaceuticals and Medical Devices Agency planned for Q4 2024\n\n\n\nRegulatory review timelines enable potential launches of sebetralstat in these territories in calendar 2025 and early 2026\n\n\n\nTo enable the broadest possible global launch, we intend to engage commercial partners in certain international markets, targeting to select initial partners over the course of 2024\n\n\n\nContinued lifecycle extension activities for sebetralstat, to grow the market opportunity\n\n\n\nCommence pediatric trial (KONFIDENT-KID) in Q3 2024, using an orally disintegrating tablet (ODT) formulation developed specifically for pediatric use. If approved, sebetralstat would be the first oral therapy in pediatric patients u...