KalVista Pharmaceuticals disclosed that interim data from its KONFIDENT‑KID trial of EKTERLY (sebetralstat) were presented at the 2026 Global Angioedema Leadership Conference on March 28, 2026, with the company announcing the results to the media on March 30, 2026.
The pediatric cohort included 33 children aged 2‑11, who collectively experienced 172 hereditary angioedema attacks. The median time from symptom onset to treatment was 25 minutes, and 67 % of attacks were treated within the first hour. In the 150 mg dose group, median symptom relief occurred after 1.5 hours and complete resolution after 12 hours.
Safety data were encouraging: no serious or treatment‑related adverse events were reported, and there were no incidents of difficulty swallowing, indicating that the oral disintegrating tablet formulation is well tolerated in this age group.
The trial is the largest pediatric study ever conducted in hereditary angioedema and supports a potential pediatric indication that could double EKTERLY’s addressable market. KalVista plans to file a U.S. new drug application for the 2‑11 age group in the third quarter of 2026, with a launch anticipated in 2027.
Commercially, EKTERLY generated $49 million in net product revenue for the eight‑month period ending December 31, 2025, including $35.4 million in the fourth quarter. The company activated 1,702 patient start forms and 724 unique prescribers in the U.S. by February 2026, and it holds approximately $300 million in cash and equivalents. Operating expenses rose to $160.2 million from $117 million in the prior year, reflecting intensified commercial launch activities.
CEO Ben Palleiko said, "Each update from KONFIDENT‑KID continues to build compelling evidence that sebetralstat has the potential to transform the treatment paradigm for children living with HAE."
Investors responded positively to the announcement, with the stock trading near its 52‑week high and having risen 62 % over the past year.
The data position EKTERLY as the first oral on‑demand therapy for children 2‑11, filling a critical unmet need that currently requires intravenous treatment. If the pediatric indication is approved, the company could capture a substantially larger patient population, strengthen its competitive advantage, and accelerate revenue growth in a high‑margin specialty‑pharma market.
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