KalVista Pharmaceuticals Inc. has revealed the initial commercial performance and market reception of EKTERLY, its recently approved oral therapy for hereditary angioedema (HAE). The data reflects positive momentum in prescriber uptake and patient adherence since the drug’s launch in mid-2025.
The U.S. Food and Drug Administration (FDA) authorized EKTERLY in July 2025 for the treatment of acute HAE attacks in both adults and pediatric patients aged 12 years and above. EKTERLY distinguishes itself as the first oral on-demand treatment available for patients suffering from this rare condition, which is characterized by episodic severe swelling known as angioedema.
KalVista reported preliminary figures indicating net product revenue of approximately $35 million for the fourth quarter and a total of $49 million for the full fiscal year 2025. This demonstrates the drug’s significant commercial uptake shortly after its U.S. market entry.
Since EKTERLY’s launch in July 2025, KalVista documented the submission of 1,318 patient start forms and activation of 580 distinct prescribers across the United States. These figures reflect both prescriber engagement and initial patient demand for the treatment.
Analysis of prescription data during the fourth quarter revealed that prescription refills outpaced new prescriptions, a development indicative of growing treatment continuity and patient reliance on EKTERLY. The company did note that some of this refilling activity may have been brought forward by holiday season dynamics.
Expanding beyond the U.S., KalVista announced a strategic agreement granting Multicare Pharmaceuticals exclusive commercialization rights for sebetralstat—EKTERLY’s active ingredient—in select Latin American markets. Multicare will lead regulatory approval processes and distribution efforts across Brazil, Argentina, Colombia, and Mexico, representing a broadening of EKTERLY’s geographical reach.
In addition to commercial milestones, KalVista advanced its clinical pipeline with the Phase 3 KONFIDENT-KID trial targeting children aged two to 11 years with HAE. The company successfully completed enrollment a full year ahead of schedule, underscoring efficient trial execution.
Following this, KalVista anticipates filing a new drug application for the pediatric indication by the third quarter of 2026, targeting a potential launch in the United States by 2027. This sequential approach aims to extend EKTERLY’s therapeutic availability to a broader pediatric population.
Reflecting investor response to these developments, KalVista’s stock price increased by over 13% to $17.86 as of the recent market close. This upward movement points to positive market sentiment following EKTERLY’s commercial and clinical progress.