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Jul 31, 2023
KalVista Q1 2024 Earnings Report
KalVista reported first fiscal quarter results and provided an operational update.
Key Takeaways
KalVista Pharmaceuticals reported its first fiscal quarter results, highlighting the achievement of target enrollment in the Phase 3 KONFIDENT trial for sebetralstat and preparations for an NDA filing in H1 2024. The company also announced the appointment of Nicole Sweeny as Chief Commercial Officer.
Target enrollment of 114 patients achieved in the phase 3 KONFIDENT trial, with data readout expected in Q4 2023.
NDA submission to the FDA anticipated in the first half of 2024, pending successful trial results.
Nicole Sweeny appointed as Chief Commercial Officer to support commercialization efforts.
Continued to advance plans for the eventual worldwide launch of sebetralstat by hiring a General Manager, Japan.
KalVista
KalVista
Forward Guidance
KalVista anticipates data readout from the Phase 3 KONFIDENT trial in Q4 2023 and, if successful, plans to submit an NDA to the FDA in the first half of 2024.
Positive Outlook
- Phase 3 KONFIDENT clinical trial achieved target enrollment.
- Data readout on track for Q4.
- Preparations continue for NDA filing H1 2024.
- Rapid commercialization upon approval is planned.
- Sebetralstat has the potential to significantly improve HAE therapeutic options in Japan.