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.
今日，KalVista Pharmaceuticals, Inc.（NASDAQ：KALV）提供了運營更新並公佈了截至2024年4月30日的財務業績。
"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."
“這是KalVista歷史上最重要的一個財季，” KalVista首席執行官Ben Palleiko表示：“我們不僅向FDA提交了sebetralstat的NDA，而且KONFIDENt 3期試驗結果發表在《新英格蘭醫學雜誌》上，支持了我們對這種潛在療法重要性的看法。我們期待在2024年向其他國家衛生當局提交額外的營銷授權申請，並預計於2025年上半年在美國獲批並上市。”