KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date for the New Drug Application (NDA) for sebetralstat, the Company’s investigational oral on-demand treatment for hereditary angioedema (HAE). 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.
KalVista Pharmaceuticals to Present New Sebetralstat Data at the European Academy of Allergy and Clinical Immunology Congress 2025
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the acceptance of six scientific abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 taking place in Glasgow, United Kingdom from June 13–16, 2025.
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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.
KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks, and the effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay. These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from May 29–June 1, 2025.
KalVista Pharmaceuticals to Present at the Jefferies Global Healthcare Conference
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today announced that the Company will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025, at 8:45 a.m. ET.
KalVista Pharmaceuticals to Present New Sebetralstat Data With 10 Abstracts Accepted at Upcoming Medical Meetings
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. The presentations will include new findings on the potential of sebetralstat to rapidly relieve symptoms and halt progression of hereditary angioedema (HAE) attacks, including mucosal and severe cases, underscoring the importance of early intervention and the role of an oral on-demand treatment option. Details of the presentations are as follows:
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today announced that the compensation committee of KalVista’s board of directors granted three newly-hired employees inducement options to purchase an aggregate of 14,000 shares of KalVista common stock on May 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.
KalVista Pharmaceuticals to Present at the Citizens Life Sciences Conference
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the Company will participate in a fireside chat at the Citizens Life Sciences Conference on Wednesday, May 7, 2025 at 11:30 a.m. ET.
KalVista Pharmaceuticals Enters Into Licensing Agreement With Kaken Pharmaceutical to Commercialize Sebetralstat for HAE in Japan
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that its wholly-owned subsidiary, KalVista Pharmaceuticals, Ltd., has licensed commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd. (JPX: 4521.T) for sebetralstat, an investigational, oral on-demand treatment for hereditary angioedema (HAE). KalVista will receive an upfront payment of $11 million, with an additional payment of up to $11 million upon achievement of a regulatory milestone anticipated in early 2026. Beyond these payments, the Company is also eligible for commercial milestone payments, plus royalties based on the Japan National Health Insurance (NHI) price, with the royalty rate as a percentage of sales approximately in the mid-twenties.
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the compensation committee of KalVista’s board of directors granted ten newly-hired employees inducement options to purchase an aggregate of 87,000 shares of KalVista common stock on April 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.
KalVista Pharmaceuticals to Present at 24th Annual Needham Virtual Healthcare Conference
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the Company will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Monday, April 7, 2025 at 1:30 p.m. ET.
KalVista Pharmaceuticals Announces Early Completion of Enrollment in KONFIDENT-KID Pediatric HAE Trial
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).
KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today released financial results for the third fiscal quarter ended January 31, 2025, and provided an operational update.
KalVista Pharmaceuticals to Host Investor Webcast Highlighting Commercialization Strategy, Plans and Progress for Sebetralstat in Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will host a virtual event to provide an overview of the commercialization strategy, plans and progress for sebetralstat, the Company’s investigational treatment for hereditary angioedema (HAE). The event will take place on Tuesday, March 25, 2025, from 8:00 a.m. to 10:00 a.m. ET. To register, please click here.
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the compensation committee of KalVista’s board of directors granted two newly-hired employees inducement options to purchase an aggregate of 14,000 shares of KalVista common stock on March 3, 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.
KalVista Pharmaceuticals Shares Latest Sebetralstat Findings at the American Academy of Allergy, Asthma & Immunology 2025 Annual Meeting
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025.
KalVista Pharmaceuticals to Present at Upcoming Investor Conferences
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the Company will participate in a fireside chat at each of the following investor conferences:
KalVista Pharmaceuticals to Present New Sebetralstat Data at the American Academy of Allergy, Asthma & Immunology 2025 Annual Meeting
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that six abstracts have been accepted for presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025.
KalVista Pharmaceuticals Presents New Sebetralstat Data at the Western Society of Allergy, Asthma & Immunology 2025 Annual Meeting
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced the presentation of novel data related to long-term prophylaxis and sebetralstat at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting taking place in Waimea, HI from February 9-13, 2025.
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV), today announced that the compensation committee of KalVista’s board of directors granted fifty-two newly-hired employees inducement options to purchase an aggregate of 261,000 shares of KalVista common stock on February 3, 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.
KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
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.
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
KalVista Pharmaceuticals, Inc. (
NASDAQ: KALV) today announced that the compensation committee of KalVista’s board of directors granted nine newly-hired employees inducement options to purchase an aggregate of 61,000 shares of KalVista common stock on January 2, 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.
