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Apr 30, 2024
KalVista Q4 2024 Earnings Report
KalVista submitted NDA for sebetralstat and announced phase 3 trial results, anticipating potential FDA approval and launch in first half 2025.
Key Takeaways
KalVista Pharmaceuticals reported no revenue for the quarter ended April 30, 2024. The company submitted the NDA for sebetralstat to the FDA and announced the KONFIDENT phase 3 trial results. They anticipate approval and launch in the US in the first half of 2025.
Submitted NDA for sebetralstat to the FDA.
Initiated a pediatric clinical trial (KONFIDENT-KID) using an orally disintegrating tablet (ODT) formulation of sebetralstat.
Data from phase 3 KONFIDENT trial of sebetralstat was published in the New England Journal of Medicine (NEJM).
KalVista is on track for Market Authorization Application submissions to both European Medicines Agency and UK Medicines and Healthcare Products Regulatory Agency in Q3 2024 as well as a JNDA submission to the Japanese Pharmaceuticals and Medical Devices Agency in Q4 2024.
Forward Guidance
KalVista is awaiting potential FDA approval and launch of sebetralstat in the first half of 2025 and plans to submit additional marketing authorization applications.
Positive Outlook
- Potential FDA approval and launch of sebetralstat in first half 2025
- Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks
- Initiated ahead of schedule a pediatric clinical trial (KONFIDENT-KID)
- Data from phase 3 KONFIDENT trial of sebetralstat was published in the New England Journal of Medicine (NEJM)
- KalVista is on track for Market Authorization Application submissions to both European Medicines Agency and UK Medicines and Healthcare Products Regulatory Agency in Q3 2024 as well as a JNDA submission to the Japanese Pharmaceuticals and Medical Devices Agency in Q4 2024.
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