KalVista's FDA Approval Raises Price Target to $40 at Jefferies

Jefferies analyst Maury Raycroft raised KalVista's price target to $40 from $32 and maintained a Buy rating after the FDA approved Ekterly for treating acute attacks of hereditary angioedema. The approval exceeded expectations with a broad label, no safety surprises, and pricing slightly higher than the firm's estimate. Raycroft also raised the firm's peak sales estimate to $700M from $532M.

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) has announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older. This approval marks a significant milestone for the company and the HAE community, as it represents the first and only oral on-demand treatment for the condition.

EKTERLY is a novel plasma kallikrein inhibitor that offers rapid symptom relief and attack resolution regardless of attack severity, location, age, or use of long-term prophylaxis. The efficacy and safety of EKTERLY were established through KalVista's phase 3 KONFIDENT clinical trial, which demonstrated significantly faster symptom relief and attack resolution compared to placebo. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries [1].

Following the FDA approval, Jefferies analyst Maury Raycroft raised KalVista's price target to $40 from $32 and maintained a Buy rating. The analyst noted that the approval exceeded expectations with a broad label, no safety surprises, and pricing slightly higher than the firm's estimate. Raycroft also raised the firm's peak sales estimate to $700M from $532M [2].

The approval of EKTERLY is expected to transform the management of HAE, providing patients with greater independence and control over managing their condition. KalVista will launch EKTERLY in the U.S. immediately, and physicians can begin writing prescriptions today. The company has also established KalVista Cares™, a comprehensive patient support program to assist eligible individuals with insurance coverage, access support, and ongoing help throughout the treatment journey [1].

KalVista will host a live conference call and webcast to discuss the FDA approval of EKTERLY today, July 7, 2025, at 8:30 a.m. ET. The webcast will be accessible through the Investors section of the Company’s website at ir.kalvista.com [1].

References:
[1] https://www.morningstar.com/news/business-wire/20250702871458/kalvista-pharmaceuticals-announces-fda-approval-of-ekterly-sebetralstat-first-and-only-oral-on-demand-treatment-for-hereditary-angioedema
[2] https://www.jefferies.com/research