KALV News & Events

KalVista Pharmaceuticals announced new interim results from its KONFIDENT-KID clinical trial evaluating EKTERLY for the on-demand treatment of hereditary angioedema attacks in children ages 2-11 presented at the 2026 Global Angioedema Leadership Conference. KONFIDENT-KID is the largest pediatric trial ever conducted in HAE. It features a proprietary oral disintegrating tablet formulation of sebetralstat in a population that currently relies on burdensome injectable treatments. The study was designed to enable compliance with treatment guidelines, consistent with the recently published "International Guideline on the Diagnosis and Management of Pediatric Patients with Hereditary Angioedema," which recommends ensuring on-demand treatment is available anytime, anywhere and prioritizes early intervention and rapid self-administration, regardless of attack severity or location. On-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID was presented by Emel Aygoren-Pursun, MD, University Hospital Frankfurt. Among 172 HAE attacks in 33 pediatric participants treated using weight-based dosing of sebetralstat in a proprietary oral disintegrating tablet formulation as of December 15, 2025: Mean 0.7 attacks treated per patient per month; Median time to treatment of 25 minutes with 67% of attacks treated within the first hour; 88.9% were mild or moderate in severity; Median times to symptom relief and complete resolution were 1.5 hours and 12 hours respectively; Sebetralstat was well tolerated with no serious or treatment-related adverse events, and no reports of difficulty swallowing. "Managing HAE attacks in children remains particularly challenging, as currently available on-demand treatments rely on injections or intravenous infusions that can be painful, anxiety-inducing, and difficult to administer promptly at symptom onset," said Dr. Aygoren-Pursun. "These barriers can contribute to treatment delays or avoidance, which may worsen outcomes. The KONFIDENT-KID data demonstrate that children and caregivers were able to treat attacks early and achieve rapid symptom relief with sebetralstat. This is especially meaningful in pediatric patients, where timely treatment can help limit swelling progression and reduce the overall duration and impact of an attack. An effective oral on-demand option has the potential to transform the treatment experience for children and families, reducing fear and burden while enabling early treatment of attacks."

Reports 8M revenue $49.1M. "As we enter the next phase of the EKTERLY launch, we are seeing the benefits of disciplined execution and increasing real-world experience with the first and only oral on-demand therapy for HAE," said Ben Palleiko, CEO of KalVista. "The trend towards high adoption continues, as evidenced by steady underlying demand and increasing utilization from patients seeking the benefits of an oral on-demand option. Internationally, EKTERLY's early performance in Germany, the recent launch in Japan by our partner Kaken Pharmaceutical and our plans to initiate additional market expansions in 2026, reinforce our confidence in the appeal across global markets. We remain focused on expanding access to EKTERLY worldwide while advancing our pediatric filing in patients aged 2-11 later this year. Together, we believe these efforts position EKTERLY to become the foundational therapy for people living with HAE."