Kalvista Pharm Stock Price, News & Analysis

KalVista Pharmaceuticals (NASDAQ:KALV) has received FDA approval for EKTERLY® (sebetralstat), marking a significant breakthrough as the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 and older.

The approval is based on the KONFIDENT phase 3 trial, the largest HAE clinical trial to date, which demonstrated significantly faster symptom relief and attack resolution compared to placebo. The KONFIDENT-S extension trial showed median symptom relief beginning at 1.3 hours for various attack types, with patients able to initiate treatment within 10 minutes of attack onset.

EKTERLY is immediately available in the U.S., supported by KalVista Cares™, a comprehensive patient support program. This approval represents the first new on-demand HAE treatment in over a decade, offering an alternative to existing injectable treatments.

KalVista Pharmaceuticals (NASDAQ:KALV) announced the granting of inducement stock options to five newly-hired employees. The compensation committee approved options to purchase a total of 23,000 shares of KalVista common stock on July 1, 2025.

The options will vest over a four-year period, with 25% vesting after one year and the remainder vesting monthly over the following three years. The exercise price is set at the closing price of KALV stock on the grant date, and the options have a 10-year term. The grants were made under KalVista's Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

KalVista Pharmaceuticals (NASDAQ:KALV) has entered into an exclusive licensing agreement with Pendopharm for the commercialization of sebetralstat in Canada. Sebetralstat is positioned to become the first oral on-demand treatment for hereditary angioedema (HAE) in the Canadian market.

Under the agreement, Pendopharm, a division of Pharmascience Inc., will manage both the regulatory approval process and commercialization of the drug in Canada. The financial terms of the partnership were not disclosed.

KalVista Pharmaceuticals presented new data at EAACI Congress 2025 demonstrating sebetralstat's effectiveness in treating HAE attacks in patients on long-term prophylaxis (LTP). The KONFIDENT-S interim analysis of 35 participants showed sebetralstat treated 382 attacks with a median treatment time of 6 minutes and symptom relief beginning at 1.3 hours. Real-world data revealed challenges with LTP adherence, with only 44% of HAE patients adhering to treatment over 12 months. Over 20% discontinued LTP, while 17% switched treatments. The study highlights sebetralstat's potential as a rapid, oral on-demand treatment option that complements existing LTP treatments, addressing the ongoing need for effective breakthrough attack management in HAE patients.

KalVista Pharmaceuticals announced that the FDA will not meet the June 17, 2025 PDUFA goal date for reviewing the New Drug Application (NDA) of sebetralstat, their oral on-demand treatment for hereditary angioedema (HAE). The delay is attributed to FDA's heavy workload and limited resources, with an expected decision within approximately four weeks. Importantly, the FDA has not requested additional data or studies and has not raised concerns about safety, efficacy, or approvability. KalVista has addressed all prior information requests, with only label finalization remaining under review. CEO Ben Palleiko expressed disappointment but maintained confidence in near-term approval.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of six scientific abstracts for presentation at the European Academy of Allergy and Clinical Immunology Congress 2025 in Glasgow, UK (June 13-16, 2025). The presentations focus on sebetralstat and hereditary angioedema (HAE) treatments, including data on psychological burden, treatment adherence, and attack management. Key presentations include interim analysis from KONFIDENT-S study on sebetralstat's effectiveness in HAE attack treatment, studies on treatment-related anxiety, and impact of delayed HAE attack treatment. Additionally, KalVista will sponsor a healthcare professional symposium titled "Closing Gaps in HAE Management" on June 14, featuring international experts discussing HAE patient control.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the granting of inducement stock options to five newly-hired employees. The compensation committee approved options to purchase a total of 50,000 shares of KalVista common stock, with the exercise price set at the closing price on June 1, 2025. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years, contingent on continued employment. The 10-year term options were granted under KalVista's Inducement Equity Incentive Plan and comply with Nasdaq Listing Rule 5635(c)(4).

KalVista Pharmaceuticals presented new data for sebetralstat, their oral treatment for hereditary angioedema (HAE) attacks, at two major medical congresses. The drug demonstrated consistent efficacy across both KONFIDENT and KONFIDENT-S trials, halting attack progression in a median time of 19.8 minutes. For mucosal attacks, patients could self-administer quickly (20 minutes for abdominal, 11.5 minutes for laryngeal attacks), with symptom relief beginning at 1.3 hours. The drug proved effective even for severe attacks, showing symptom relief in 1.36 hours when treatment was delayed. Notably, 96% of attacks reaching symptom relief within 12 hours did so without needing additional sebetralstat doses. The drug maintained a favorable safety profile, particularly important for laryngeal attacks where swallowing difficulties could be concerning.

KalVista Pharmaceuticals (NASDAQ: KALV) announced its participation in a fireside chat at the Jefferies Global Healthcare Conference. The presentation is scheduled for Thursday, June 5, 2025, at 8:45 a.m. ET. Investors and interested parties can access a live webcast of the presentation through KalVista's website at www.kalvista.com. The audio recording will remain available on the company's website for 30 days following the presentation.