KalVista Submits FDA Application for Sebetralstat; Phase 3 Trial Results Published
KalVista Submits FDA Application for Sebetralstat; Phase 3 Trial Results Published
KalVista向FDA提交Sebetralstat申請；第3期試驗結果已發佈。
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2024.
"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."