KalVista’s Pediatric HAE Trial for Sebetralstat Reaches Completion, Setting Up a Key Catalyst for KALV

KalVista Pharmaceuticals, Inc. (KALV) announced an update on their ongoing clinical study.

Study Overview

KalVista Pharmaceuticals is running a pediatric study titled “Open-Label Safety, Pharmacokinetic, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With Hereditary Angioedema Type I or II.” The goal is to see how safe the drug is, how it moves through the body, and how well it works in young children who suffer from sudden swelling attacks. This is important because current options for this age group are limited and harder to use, and an easy-to-take oral treatment could change the standard of care and support KalVista’s broader HAE franchise story.

Intervention/Treatment

The treatment being tested is sebetralstat, also called KVD900, given as an oral tablet. It is designed to treat acute hereditary angioedema attacks by blocking a pathway that leads to swelling. Children in the trial receive single doses of KVD900 at three different tablet strengths: 150 mg, 300 mg, or 600 mg.

Study Design

This is an interventional Phase 3 trial. Patients are assigned to dose groups without randomization, so there is no placebo or comparison drug. The model is “parallel,” meaning each group receives one fixed dose level. There is no blinding; doctors, patients, and the sponsor all know which dose is used. The main purpose is treatment-focused: to see if KVD900 is safe and active enough in real-world use for children with hereditary angioedema.

Study Timeline

The study was first submitted to the registry on June 14, 2024, indicating when the trial plan became visible to the public and regulators. The trial is now listed as completed, which means patient visits and dosing are done and data are being analyzed. An important milestone is the latest update filed on January 22, 2026, which confirms the status and protocol details. No results have been posted yet, signaling that top-line data have not been officially shared on the registry at the time of the last update.

Market Implications

Completion of this pediatric trial is a key catalyst for KalVista (KALV). If data later show good safety and effectiveness, it could support label expansion of sebetralstat into younger patients, lifting the long-term revenue outlook and strengthening the company’s position in the hereditary angioedema market. For now, the update mainly reduces execution risk, as it confirms the trial ran to completion without being halted. Investors may view this as a modest positive and may start to price in the chance of broader adoption of an oral acute HAE drug, especially given patient convenience versus injectable therapies offered by larger players like Takeda and CSL. However, without posted results, the core clinical and commercial risk remains, so share price reaction may be limited until top-line efficacy and safety data are disclosed. The study is now completed but still in the data-analysis stage, with more details to come on the ClinicalTrials portal.

To learn more about KALV’s potential, visit the KalVista Pharmaceuticals, Inc. drug pipeline page.