KalVista Pharmaceuticals Inc. (NASDAQ:KALV) on Thursday reported early commercial momentum for its hereditary angioedema treatment EKTERLY, highlighting growing prescriber adoption, repeat prescriptions and expanding global access following its mid-2025 launch.
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In July 2025, the U.S. Food and Drug Administration (FDA) approved Ekterly for acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
Ekterly is the first and only oral on-demand treatment for HAE. HAE, which is rare, is characterized by recurrent episodes of severe swelling (angioedema).
The company disclosed preliminary net product revenue of approximately $35 million for the fourth quarter and $49 million for the fiscal year 2025.
Ekterly (sebetralstat) was commercially launched in the U.S. in July 2025.
Through year-end, the company recorded 1,318 patient start forms and activated 580 unique prescribers across the U.S. market.
In the fourth quarter, prescription refills overtook new prescriptions as the primary revenue driver, reflecting growing continuity of use among patients. The company noted some activity may have been accelerated ahead of the holiday period.
Ekterly’s commercial expansion also extended beyond the U.S. KalVista granted Multicare Pharmaceuticals exclusive rights to commercialize sebetralstat in Latin America.
Under the agreement, Multicare will oversee regulatory approvals and distribution efforts in Brazil, Argentina, Colombia and Mexico.
The company completed enrollment in the Phase 3 KONFIDENT-KID trial evaluating sebetralstat in children aged two to 11 with hereditary angioedema, finishing a full year ahead of schedule.
KalVista expects to submit a new drug application for the pediatric indication in the third quarter of 2026, with a potential U.S. launch targeted for 2027.
KALV Price Action: Kalvista Pharmaceuticals stock is up 13.18% at $17.86 at publication on Friday.
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