Kalvista Pharm Stock Price, News & Analysis

KalVista Pharmaceuticals (NASDAQ:KALV) announced the granting of inducement stock options to two new employees. The compensation committee approved options to purchase a total of 5,000 shares of KalVista common stock on September 1, 2025.

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

KalVista Pharmaceuticals (NASDAQ:KALV) announced its upcoming participation in the Cantor Global Healthcare Conference 2025. The company will engage in a fireside chat on Wednesday, September 3, 2025, at 10:55 a.m. ET.

Investors 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.

KalVista Pharmaceuticals (NASDAQ:KALV) announced that sebetralstat, its novel oral plasma kallikrein inhibitor for hereditary angioedema (HAE), has maintained its orphan drug designation from the European Medicines Agency (EMA). This achievement makes sebetralstat one of only two HAE therapies to maintain orphan status in the EU.

The designation was maintained based on sebetralstat's comparable efficacy to injectable treatments while offering significant benefits to patient care. If approved, the drug will receive 10 years of market exclusivity in the EU. The European Commission's final decision is expected by early October 2025, following a positive CHMP opinion.

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).