With HAE Drug EKTERLY Off To A Strong Start, Is Now The Time To Keep An Eye On KalVista Stock?

KalVista Pharmaceuticals

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(RTTNews) - In July 2025, this pharmaceutical company started its new phase of growth as a commercial entity, following the landmark approval of the first and only oral on-demand treatment for Hereditary Angioedema (HAE). With initial demand surpassing expectations, the company is confident that its HAE treatment has the potential to become a core therapy in HAE management.

The company we are profiling today is KalVista Pharmaceuticals Inc. (KALV), the developer of EKTERLY, the first and only oral on-demand treatment for hereditary angioedema.

Hereditary angioedema is a rare, lifelong disease, characterised by unpredictable and often debilitating swelling episodes affecting areas such as the face, limbs, and abdomen. Symptoms take 2 to 5 days to resolve. Although there have been several approved treatments for HAE, most have required injections or infusions - until the approval of EKTERLY in July, which marked a major advancement as the first oral, on-demand treatment option.

EKTERLY is approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older.

The approval was based on the phase 3 KONFIDENT clinical trial, in which EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo.

According to the company, EKTERLY is poised to become a foundational treatment in the management of hereditary angioedema (HAE), as it enables early treatment of all attacks to improve outcomes. Taken immediately upon attack recognition, the drug has been proven to rapidly and safely stop the progression of HAE episodes - without the need for needles or the discomfort of injections. Its effectiveness spans all types of HAE attacks, regardless of their location, severity, or whether patients are on prophylactic therapy, positioning it as a game-changing option in comprehensive HAE care.

There are two ongoing trials with EKTERLY:

-- A phase 3 open-label extension trial of EKTERLY in adolescent and adult patients with hereditary angioedema, dubbed KONFIDENT-S. -- A phase 3 open-label, multicenter trial of EKTERLY in patients aged 2 to 11 years old with HAE, dubbed KONFIDENT-KID.

The company is scheduled to present new EKTERLY data from the KONFIDENT-S trial at the 20th German Allergy Congress, taking place in Düsseldorf, Germany, from October 2-4, 2025.

Initial results from the KONFIDENT-KID trial are expected later this year, with a supplemental new drug application filing anticipated by mid-2026.

Early Market Response & Uptake

Following FDA approval on July 7, 2025, the company initiated the U.S. commercial launch of EKTERLY on the same day. For the quarter ended July 31, 2025, the U.S. sales of EKTERLY, which became commercially available in mid-July, were $1.4 million.

The drug is expected to generate sales of $700 million at its peak, according to Jefferies analyst Maury Raycroft. The company sees a market opportunity of $1.5 billion for EKTERLY.

Upcoming Launches

In the European Union, the company expects the first launch in Germany in Q4 2025. In Switzerland, the drug is anticipated to become available in the second half of 2026, pending reimbursement finalization. In the United Kingdom, although EKTERLY received marketing authorisation in July 2025, it will remain available exclusively through the Early Access to Medicines Scheme (EAMS) until a decision is issued by the National Institute for Health and Care Excellence (NICE) regarding its use under the National Health Service (NHS) - a decision that is anticipated in the first half of 2026.

Cash Position

The company held cash, cash equivalents, and marketable securities of approximately $191.5 million as of July 31, 2025.

Privately held KalVista made its debut on the NASDAQ Stock Market under the symbol "KALV" on November 22, 2016, following a reverse merger with Carbylan Therapeutics Inc. (Nasdaq: CBYL).

KALV has traded in a range of $7.30 to $17.28 in the last 1 year. The stock closed yesterday's trading at $12.40, up 2.52%.