KalVista Submits FDA Application for Sebetralstat; Phase 3 Trial Results Published
KalVista Submits FDA Application for Sebetralstat; Phase 3 Trial Results Published
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2024.
KalVista Pharmicals, Inc.（纳斯达克股票代码：KALV）今天提供了最新运营情况，并发布了截至2024年4月30日的财年财务业绩。
"This last fiscal quarter was the most important in the history of KalVista," said Ben Palleiko, CEO of KalVista. "Not only did we submit the NDA for sebetralstat to the FDA, but the KONFIDENT phase 3 trial results were published in The New England Journal of Medicine, supporting our view on the importance of this potential therapy. We look forward to building on these milestones as we submit additional marketing authorization applications to other national health authorities throughout 2024 and anticipate approval and launch in the US in the first half of 2025."
KalVista首席执行官本·帕莱科说：“上一个财季是KalVista历史上最重要的财季。”“我们不仅向美国食品药品管理局提交了sebetralstat的保密协议，而且KonfiDent的3期试验结果也发表在《新英格兰医学杂志》上，支持了我们对这种潜在疗法重要性的看法。我们期待在这些里程碑的基础上再接再厉，在2024年全年向其他国家卫生当局提交更多上市许可申请，并预计将在2025年上半年在美国获得批准和推出。”