KalVista Pharmaceuticals has observed promising initial commercial performance for its novel hereditary angioedema (HAE) medication, EKTERLY. Since its introduction in mid-2025, the oral treatment has garnered significant interest from prescribers, leading to a notable increase in repeat prescriptions and broader international accessibility. This encouraging market reception is further substantiated by the company's preliminary financial results for the 2025 fiscal year, signaling a strong start for this innovative therapy.
In July 2025, EKTERLY, an on-demand oral treatment for acute hereditary angioedema attacks, received approval from the U.S. Food and Drug Administration (FDA) for patients aged 12 and above. This approval marked a significant milestone, positioning EKTERLY as the first and only oral on-demand therapy for HAE, a rare condition characterized by recurrent severe swelling episodes. The drug's unique oral formulation offers a convenient and accessible option for patients managing this challenging disease.
KalVista Pharmaceuticals reported preliminary net product revenue of approximately $35 million for the fourth quarter of 2025 and a total of $49 million for the entire fiscal year 2025. By the end of the year, the company had processed 1,318 patient start forms and engaged 580 distinct prescribers across the U.S. market, indicating a rapid and widespread adoption of EKTERLY. The shift from new prescriptions to refills as the primary revenue driver in the fourth quarter underscores the sustained use of the drug among patients, with some of this activity potentially accelerated before the holiday season.
Beyond the domestic market, KalVista has initiated global expansion efforts. A strategic agreement with Multicare Pharmaceuticals grants exclusive rights to commercialize sebetralstat, the active compound in EKTERLY, across Latin America. This partnership will see Multicare spearhead regulatory approvals and distribution in key markets including Brazil, Argentina, Colombia, and Mexico, further extending the drug's reach to patients in need. Additionally, the company successfully completed enrollment for the Phase 3 KONFIDENT-KID trial, evaluating sebetralstat in children aged two to eleven, a full year ahead of schedule. KalVista anticipates submitting a New Drug Application for this pediatric indication in the third quarter of 2026, aiming for a U.S. launch in 2027.
The early commercial success of EKTERLY, driven by strong prescriber uptake and patient continuity, demonstrates the significant impact of this first-in-class oral treatment for hereditary angioedema. With promising financial returns and a clear path for pediatric expansion and international growth, KalVista Pharmaceuticals is poised to deliver a valuable solution to a patient population with limited treatment options. The positive market response is reflected in the company's stock performance, highlighting investor confidence in EKTERLY's potential.