Latest news with #KalVista
Business Insider
a day ago
- Business
- Business Insider
KalVista says FDA will not meet PDUFA goal date for Sebetralstat NDA
KalVista (KALV) Pharmaceuticals nnounced that the U.S. Food and Drug Administration has notified the company that it will not meet the PDUFA goal date for the New Drug Application for sebetralstat, the company's investigational oral on-demand treatment for hereditary angioedema. The FDA notified the company on June 13, 2025, that the previously disclosed June 17, 2025 PDUFA goal date will not be met due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks. The FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. KalVista has addressed all prior information requests in a timely manner, and the company believes the only remaining item under FDA review is the finalization of the labelling. 'We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,' said Ben Palleiko, CEO of KalVista. 'At the same time, we remain confident in the near-term approval of sebetralstat. We are continuing to work closely with the FDA to support the completion of their review. Our commitment to bringing this important therapy to people living with HAE remains unwavering.'
Cision Canada
a day ago
- Business
- Cision Canada
DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals' Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints
- FDA decision anticipated within four weeks - TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals ("KalVista") has disclosed that it has received notice from the U.S. Food and Drug Administration ("FDA") that the FDA will not meet the June 17, 2025 PDUFA goal date for the New Drug Application (NDA) for sebetralstat, due to a heavy workload and agency resourcing issues. KalVista commented that the FDA has not requested additional data or studies and has communicated to KalVista that it anticipates delivering a decision within approximately four weeks. KalVista issued its own press release with the announcement earlier today (link). About DRI Healthcare Trust The Trust is managed by DRI Capital Inc., a pioneer in global pharmaceutical royalty monetization. Since its initial public offering in 2021, the Trust has deployed more than $1.0 billion, acquiring more than 25 royalties on 20-plus drugs, including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula and Zytiga. The Trust's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol " and in U.S. dollars under the symbol "DHT.U". To learn more, visit or follow us on LinkedIn. SOURCE DRI Healthcare Trust
Yahoo
a day ago
- Business
- Yahoo
DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals' Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints
- FDA decision anticipated within four weeks - TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals ("KalVista") has disclosed that it has received notice from the U.S. Food and Drug Administration ("FDA") that the FDA will not meet the June 17, 2025 PDUFA goal date for the New Drug Application (NDA) for sebetralstat, due to a heavy workload and agency resourcing issues. KalVista commented that the FDA has not requested additional data or studies and has communicated to KalVista that it anticipates delivering a decision within approximately four weeks. KalVista issued its own press release with the announcement earlier today (link). About DRI Healthcare Trust The Trust is managed by DRI Capital Inc., a pioneer in global pharmaceutical royalty monetization. Since its initial public offering in 2021, the Trust has deployed more than $1.0 billion, acquiring more than 25 royalties on 20-plus drugs, including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula and Zytiga. The Trust's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol " and in U.S. dollars under the symbol "DHT.U". To learn more, visit or follow us on LinkedIn. SOURCE DRI Healthcare Trust View original content to download multimedia:
Reuters
a day ago
- Health
- Reuters
US FDA extends review of KalVista's swelling disorder drug due to heavy workload
June 13 (Reuters) - The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' (KALV.O), opens new tab drug for a type of hereditary swelling disorder due to heavy workload and limited resources, the company said on Friday. The FDA indicated that it now expects to deliver a decision within four weeks, KalVista said. The original target action date for the decision on the medication, named sebetralstat, was set for June 17 by the regulator. The extension is the latest instance of the FDA missing a deadline following mass layoffs under a major overhaul of federal health agencies under U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. The regulator also missed the target date for GSK's Nucala to treat smoker's lung. KalVista said the FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat. The company also said it has addressed all prior information requests in a timely manner and believes the only remaining item under FDA review is the finalization of the packaging insert.
Yahoo
03-06-2025
- Business
- Yahoo
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass. & SALISBURY, England, June 03, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today announced that the compensation committee of KalVista's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 50,000 shares of KalVista common stock on June 1, 2025 as inducements material to each employee entering into employment with KalVista. The options have an exercise price that is equal to the closing price of KalVista common stock on the grant date. One-fourth of the options vest on the one-year anniversary of the vesting commencement date and the remainder vest in equal monthly installments over the next three years, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of KalVista's Inducement Equity Incentive Plan and a stock option agreement covering the grant. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4). About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow on social media at @KalVista and LinkedIn. View source version on Contacts KalVista Pharmaceuticals, Inc. Investors: Ryan BakerHead, Investor Relations(617) Media: Molly CameronDirector, Corporate Communications(857)
