KalVista completes enrollment for pediatric HAE trial

CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) has announced the completion of enrollment for its KONFIDENT-KID clinical trial, which evaluates sebetralstat, a potential oral treatment for hereditary angioedema (HAE) in children aged two to 11. The company reached its initial target enrollment ahead of schedule and expanded the trial due to high demand.

The trial, which began with a goal to enroll 24 pediatric patients, has now included approximately 36 participants across North America, Europe, and Asia. KONFIDENT-KID is designed to collect safety, pharmacokinetic, and efficacy data over a period of up to one year, utilizing a pediatric oral disintegrating tablet formulation of sebetralstat. According to InvestingPro data, KalVista maintains a strong financial position with more cash than debt on its balance sheet, providing adequate runway for its clinical development programs.

This development is particularly significant as the only current on-demand treatment for HAE in this age group in the U.S. requires intravenous administration. Sebetralstat stands to be the first oral on-demand therapy for pediatric patients in this demographic, and only the second FDA-approved on-demand therapy for them overall.

KalVista’s CEO, Ben Palleiko, expressed the company’s pride in the swift enrollment and the strong interest from families affected by HAE, emphasizing the need for an oral treatment option. Initial results from the trial are expected to be made public later this year, with a supplemental New Drug Application (sNDA) submission anticipated by mid-2026. Analysts maintain a bullish outlook on KalVista, with price targets ranging from $18 to $39 per share, and seven analysts have recently revised their earnings expectations upward.

Sebetralstat is an investigational oral plasma kallikrein inhibitor currently under review by the U.S. FDA for patients aged 12 and older, with a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025. The company has also submitted Marketing Authorization Applications to the European Medicines Agency and other global regulatory authorities.

HAE is a rare genetic condition characterized by spontaneous and often severe swelling in various parts of the body. The disease is caused by a deficiency or dysfunction of the C1 esterase inhibitor protein, leading to uncontrolled activation of the kallikrein-kinin system. Existing on-demand treatments for HAE require either intravenous or subcutaneous administration. While KalVista’s overall financial health score from InvestingPro is rated as "Fair," the company maintains a strong liquidity position with a current ratio of 10.44, indicating robust short-term financial stability.

The information in this article is based on a press release statement from KalVista Pharmaceuticals, Inc.

In other recent news, Kalvista Pharmaceuticals Inc. has been the subject of several analyst reports and clinical updates. The company is preparing for the anticipated launch of its investigational drug sebetralstat, an oral therapy for hereditary angioedema (HAE), with a key regulatory date set for June 17, 2025. Analysts at H.C. Wainwright have reiterated a Buy rating with a $20 target, citing the drug’s potential ease of use compared to current injectable treatments. Meanwhile, Jefferies adjusted its price target from $33 to $31 while maintaining a Buy rating, reflecting ongoing preparations for the U.S. launch of sebetralstat.

New data presented at the AAAAI/WAO 2025 Joint Congress highlighted sebetralstat’s promise in reducing the time to relief for HAE attacks, with a median time of 11.5 minutes from attack onset to treatment. JMP Securities also reaffirmed their Market Outperform rating with a $19 target, emphasizing the drug’s potential to expand the on-demand treatment market for HAE. Kalvista plans to provide further insights into its commercial strategy during a virtual Investor Day event. The company’s efforts to address unmet needs in HAE treatment with an oral option are central to its strategy, with regulatory applications filed in multiple global markets.

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