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Jul 31, 2024
KalVista Q1 2025 Earnings Report
KalVista reported first fiscal quarter results and provided an operational update.
Key Takeaways
KalVista Pharmaceuticals reported no revenue for the first fiscal quarter ended July 31, 2024. Net loss was $40.4 million, or $(0.87) per share. Cash, cash equivalents, and marketable securities were $174.3 million on July 31, 2024.
FDA accepted NDA for sebetralstat with a PDUFA goal date of June 17, 2025.
EMA validated the submission of Marketing Authorization Application (MAA) for sebetralstat.
KalVista expects to file for approval in the UK, Japan, and other countries later in 2024.
A pediatric clinical trial (KONFIDENT-KID) using an orally disintegrating tablet (ODT) formulation of sebetralstat designed for this population was initiated.
Forward Guidance
KalVista expects to file for approval in the UK, Japan, and other countries later in 2024 and aim for their first commercial launch of sebetralstat in June 2025.
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