KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (KALV)
Last kalvista pharmaceuticals, inc. earnings: 3/10 07:30 am
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Source: Business Wire
– If approved, sebetralstat will be the first, oral on-demand treatment for HAE –– FDA PDUFA goal date of June 17, 2025 – CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in adult and pediatric patients aged 12 years and older. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.“We are thrilled with the FDA’s acceptance of our NDA for sebetralstat as it moves us one step closer to bringing a potentially transformative
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News
- KalVista Pharmaceuticals to Present at Upcoming Investor ConferencesBusiness Wire
- KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- DRI Healthcare Trust Announces Acquisition of a Synthetic Royalty Interest in the Worldwide Sales of Sebetralstat for the Treatment of Hereditary Angioedema Plus an Equity Investment in KalVista Pharmaceuticals [Yahoo! Finance]Yahoo! Finance
- KalVista Pharmaceuticals Announces Pricing of a $55 Million Underwritten Offering of Common Stock and Concurrent Private Placement of $5 MillionBusiness Wire
- KalVista Pharmaceuticals Enters into Non-Dilutive Synthetic Royalty Financing with DRI Healthcare TrustBusiness Wire
KALV
Earnings
- 9/5/24 - Beat
KALV
Sec Filings
- 11/19/24 - Form 4
- 11/19/24 - Form 4
- 11/19/24 - Form 4
- KALV's page on the SEC website