Welcome to our dedicated page for Kalvista Pharm news (Ticker: KALV), a resource for investors and traders seeking the latest updates and insights on Kalvista Pharm stock.
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) generates frequent news flow around its work in hereditary angioedema (HAE) and the commercialization of EKTERLY (sebetralstat). Company press releases highlight regulatory approvals, commercial launches, clinical data presentations and financial updates tied to this first and only oral on-demand treatment for acute HAE attacks in people 12 years of age and older.
News items cover major milestones such as FDA approval of EKTERLY in the United States, subsequent approvals in the European Union, United Kingdom, Switzerland, Australia, Singapore and Japan, and the initiation of commercial launches in the U.S. and Germany. KalVista also reports on licensing and commercialization agreements with partners like Kaken Pharmaceutical in Japan, Pendopharm in Canada and Multicare Pharmaceuticals in Latin America, which expand EKTERLY’s reach into additional markets.
Investors and clinicians following KALV can track updates on net product revenue from EKTERLY, patient start forms, prescriber activation and refill trends, as well as financing events such as the issuance of convertible senior notes. The company regularly announces new clinical and real‑world data from the KONFIDENT, KONFIDENT‑S and KONFIDENT‑KID studies, including patient satisfaction, pediatric interim results and European experience with sebetralstat, often presented at meetings such as the American College of Allergy, Asthma & Immunology Annual Scientific Meeting and the German Allergy Congress.
Additional KalVista news includes corporate governance developments, board and executive appointments, inducement equity grants and participation in healthcare investor conferences. This news page allows readers to follow how KalVista advances EKTERLY globally, engages with the HAE community and reports on its operational and financial progress over time.
KalVista Pharmaceuticals (NASDAQ:KALV) announced the granting of inducement stock options to six newly-hired employees. The compensation committee approved options to purchase a total of 44,000 shares of KalVista common stock on August 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 equals the closing price on the grant date, and the options have a 10-year term. These grants were made under KalVista's Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
KalVista Pharmaceuticals (NASDAQ:KALV) has received a positive opinion from the European Medicines Agency's CHMP recommending marketing authorization for sebetralstat, their novel oral plasma kallikrein inhibitor for treating hereditary angioedema (HAE) attacks. The treatment, if approved, will become the first and only oral on-demand treatment for HAE in the EU.
The recommendation is based on the phase 3 KONFIDENT trial, the largest HAE clinical trial to date, involving 136 patients across 66 sites in 20 countries. The trial demonstrated significantly faster symptom relief and attack resolution compared to placebo. The European Commission's final decision is expected by early October 2025. Sebetralstat is already approved in the US and UK under the brand name EKTERLY® and is under review in Japan and other territories.
KalVista Pharmaceuticals (NASDAQ:KALV) has received UK MHRA approval for EKTERLY® (sebetralstat), marking a significant milestone 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 phase 3 KONFIDENT trial, the largest HAE clinical study ever conducted, involving 136 patients across 66 sites in 20 countries. The trial demonstrated significantly faster symptom relief and attack resolution compared to placebo. EKTERLY will receive 10 years of market exclusivity under MHRA's Orphan Register.
This approval follows the recent FDA authorization on July 3, 2025, with additional applications pending in the EU, Japan, and other markets. The company expects an NHS coverage decision through NICE in the first half of 2026.
KalVista Pharmaceuticals (NASDAQ:KALV) has achieved a significant milestone with the FDA approval of EKTERLY® (sebetralstat), the first and only oral on-demand treatment for hereditary angioedema (HAE) in patients aged 12 and older. The company has launched the drug in the U.S. and secured licensing agreements with Kaken Pharmaceutical for Japan ($24M in payments) and Pendopharm for Canada.
Clinical data presented at multiple conferences demonstrated EKTERLY's effectiveness, showing a median time to symptom relief of 1.3 hours and attack progression stopping within 19.8 minutes. The company's financial position remains strong with $220.6M in cash, providing runway into 2027, despite increased G&A expenses of $116.3M due to pre-commercial activities.
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.
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