CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) has submitted Marketing Authorization Applications (MAAs) for sebetralstat, a novel investigational oral treatment for hereditary angioedema (HAE), to regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore. These submissions, made through the Access Consortium framework, aim to address the unmet need for an on-demand oral treatment for HAE sufferers worldwide.
Sebetralstat, if authorized, could become the first oral medication for on-demand management of HAE attacks in adults and adolescents aged 12 and older. This development follows KalVista's recent announcement of a June 17, 2025 Prescription Drug User Fee Act (PDUFA) date set by the U.S. FDA and the validation of its MAA by the European Medicines Agency (EMA).
The MAAs are supported by data from the KONFIDENT phase 3 clinical trial, which demonstrated that sebetralstat significantly accelerated the onset of symptom relief compared to placebo. The ongoing KONFIDENT-S open label extension trial has shown a consistent safety and efficacy profile for sebetralstat, with a median time to beginning of symptom relief for laryngeal attacks of 1.3 hours.
Additionally, the KONFIDENT-KID clinical trial, evaluating sebetralstat in children aged 2-11 years, commenced dosing ahead of schedule in June 2024. This trial could position sebetralstat as the first oral on-demand therapy for this age group, pending approval.
Sebetralstat has received Fast Track and Orphan Drug Designations from the U.S. FDA and similar designations from the EMA. HAE is a rare genetic condition characterized by spontaneous and often painful swelling in various body parts, which can be life-threatening depending on the affected location. Current on-demand treatments for HAE require either intravenous or subcutaneous administration, highlighting the need for more accessible treatment options like sebetralstat.
KalVista's focus on patient needs and the limitations of existing therapies has shaped its approach to developing treatments that could significantly improve the lives of those with HAE. The information in this article is based on a press release statement from KalVista Pharmaceuticals, Inc.
In other recent news, KalVista Pharmaceuticals has made significant strides in the development of sebetralstat, a potential treatment for hereditary angioedema (HAE). Jones Trading has initiated coverage on KalVista, issuing a Buy rating with a $35.00 price target. The firm anticipates a rebound in the company's stock as the FDA's Prescription Drug User Fee Act (PDUFA) date of June 17, 2025, for sebetralstat approaches. Meanwhile, H.C. Wainwright and Leerink Partners have reiterated a Buy and Outperform rating respectively, with a $20.00 price target.
KalVista has also announced the appointment of a new CFO, Brian Piekos, who brings over 25 years of financial and strategic planning experience in the biopharmaceutical industry. The company's New Drug Application (NDA) for sebetralstat has been accepted by the FDA, and the European Medicines Agency (EMA) has begun reviewing the Marketing Authorization Application (MAA), marking progress in introducing the drug to the European market.
In addition, KalVista has initiated a pediatric trial for sebetralstat and plans to start a study for adolescent and adult patients in the fourth quarter of 2024. These are the recent developments in KalVista's ongoing efforts to provide innovative treatments for diseases with significant unmet medical needs.
InvestingPro Insights
KalVista Pharmaceuticals' (NASDAQ: KALV) recent regulatory submissions for sebetralstat reflect its commitment to addressing the unmet needs in HAE treatment. This strategic move aligns with the company's financial position and market performance.
According to InvestingPro data, KalVista's market capitalization stands at $533.28 million, indicating significant investor interest in the company's potential. The stock has shown a remarkable 26.18% return over the past week, suggesting positive market sentiment surrounding these recent developments.
However, it's important to note that KalVista is currently operating at a loss, with a negative gross profit of $93.47 million in the last twelve months. This aligns with an InvestingPro Tip highlighting that the company is not profitable over the last twelve months. This is not uncommon for biotech companies in the development stage, as they often incur substantial research and development costs before bringing products to market.
Another InvestingPro Tip reveals that KalVista holds more cash than debt on its balance sheet. This financial cushion could be crucial as the company navigates the regulatory approval process and potential commercialization of sebetralstat.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for KalVista Pharmaceuticals, providing deeper insights into the company's financial health and market position.
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