KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema [Yahoo! Finance]
KalVista Pharmaceuticals, Inc. (KALV)
Last kalvista pharmaceuticals, inc. earnings: 3/10 07:30 am
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Source: Yahoo! Finance
– Submission advances Company's strategic plan to address unmet needs in HAE on global scale– CAMBRIDGE, Mass. & SALISBURY, England, January 21, 2025 BUSINESS WIRE KalVista Pharmaceuticals, Inc . (NASDAQ: KALV), today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation. The Company has also submitted a New Drug Application (NDA) for sebetralstat to the Agency. If approved, sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older, would be the first oral on-demand treatment for HAE in Japan. "The submission of our NDA for sebetralstat in Japan represents another key step toward our efforts to make this important new treatment available to as many people living with HAE as possible," said Ben Palleiko, CEO of KalVista. "The Orphan Drug Designation not only acknowledges the critical need
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News
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- KalVista Pharmaceuticals, Inc. (KALV) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
KALV
Earnings
- 11/10/25 - Beat
KALV
Sec Filings
- 12/9/25 - Form 4
- 12/4/25 - Form 4
- 11/26/25 - Form 4
- KALV's page on the SEC website