financetom
Business
financetom
/
Business
/
KalVista Says New Drug Application for Sebetralstat Accepted by FDA
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
KalVista Says New Drug Application for Sebetralstat Accepted by FDA
Sep 3, 2024 8:07 PM

11:57 AM EDT, 09/03/2024 (MT Newswires) -- KalVista Pharmaceuticals ( KALV ) said Tuesday the US Food and Drug Administration has accepted its New Drug Application (NDA) for sebetralstat to treat hereditary angioedema attacks, with a target action date of June 17, 2025.

KalVista said the FDA is not currently planning to hold an advisory committee meeting on the application.

The company said it is seeking approval for sebetralstat, an investigational oral plasma kallikrein inhibitor, in patients aged 12 and older.

The application was supported by data from a phase 3 clinical trial and an ongoing open label extension trial, the company said.

Shares of KalVista were down 5.9% in recent trading.

Price: 12.59, Change: -0.80, Percent Change: -5.94

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Kalshi is subject to Nevada gaming rules, judge finds
Kalshi is subject to Nevada gaming rules, judge finds
Mar 10, 2026
* Nevada gaming board said state-level regulation needed * Robinhood agreed to halt sports contracts in Nevada * Kalshi is appealing decision, lawyer declines comment (Adds details from decision, separate Robinhood order, comments, DraftKings ( DKNG ) and FanDuel parent stock prices, byline) By Jonathan Stempel Nov 26 (Reuters) - A federal judge said the prediction markets platform Kalshi is...
A-Mark Precious Metals Insider Sold Shares Worth $527,400, According to a Recent SEC Filing
A-Mark Precious Metals Insider Sold Shares Worth $527,400, According to a Recent SEC Filing
Mar 10, 2026
12:04 PM EST, 11/26/2025 (MT Newswires) -- Gregory N Roberts, 10% Owner, Director, Chief Executive Officer, on November 25, 2025, sold 20,000 shares in A-Mark Precious Metals ( AMRK ) for $527,400. Following the Form 4 filing with the SEC, Roberts has control over a total of 1,927,958 common shares of the company, with 28,202 shares held directly and 1,899,756...
Banco Sabadell, ICO sign $70 million financing deal for Spanish firms in Mexico
Banco Sabadell, ICO sign $70 million financing deal for Spanish firms in Mexico
Mar 10, 2026
MEXICO CITY, Nov 26 (Reuters) - Spain's state-owned development bank, the Instituto de Credito Oficial, and lender Sabadell's Mexico unit signed a $70 million financing agreement on Wednesday to support Spanish-linked companies operating in Mexico, marking their fourth such deal in six years. KEY CONTEXT -- The agreement is part of ICO's International Channel Line, which provides financing for Spanish...
US extends tariff exclusions related to China tech transfer probe
US extends tariff exclusions related to China tech transfer probe
Mar 10, 2026
WASHINGTON (Reuters) -The United States on Wednesday said it was extending into November 2026 tariff exclusions that had been due to expire later this month related to a probe of China's practices on technology transfer and intellectual property. The extension of the exclusions follows the historic trade and economic deal reached between President Trump and President Xi Jinping of China...
Copyright 2023-2026 - www.financetom.com All Rights Reserved