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KalVista Pharmaceuticals develops oral small-molecule inhibitors that target the kallikrein-kinin system to treat rare diseases such as hereditary angioedema (HAE). Its lead product, EKTERLY (sebetralstat), is an oral, on-demand plasma kallikrein inhibitor approved by the FDA for acute HAE attacks in patients 12 and older, taken at attack onset. The company is pursuing an orally disintegrating tablet version for pediatric patients and exploring an oral Factor XIIa inhibitor for prophylaxis, while building a commercial platform for global market access. KalVista aims to translate scientific knowledge into practical, patient-friendly therapies and generate revenue through product sales, milestones, and royalties from partnerships as it moves toward commercialization.
Industries
Biotechnology
Healthcare
Company Size
201-500
Company Stage
IPO
Headquarters
Cambridge, Massachusetts
Founded
2011
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Total Funding
$3B
Above
Industry Average
Funded Over
7 Rounds
Health Insurance
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Unlimited Paid Time Off
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Parental Leave
Family Planning Benefits
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Elder Care Support
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KalVista Pharmaceuticals reported interim results from its KONFIDENT-KID trial showing that oral EKTERLY (sebetralstat) successfully treated 172 hereditary angioedema attacks in 33 children aged 2-11. The treatment was rapid and well-tolerated, offering a potential alternative to current injectable therapies. The trial, now the largest paediatric hereditary angioedema study, completed enrolment a year early. KalVista plans to file a US paediatric new drug application in the third quarter of 2026, which could bring the first oral on-demand treatment option to this age group. The company reported a net loss of $109.52 million over eight months in 2025 as it invested in EKTERLY's launch. Analysts are projecting revenue of $343.5 million and earnings of $58.5 million by 2029.
KalVista Pharmaceuticals announces positive interim Phase 3 data from KONFIDENT-KID trial of EKTERLY(R)(sebetralstat) for Children Aged 2-11 years at the 2026 Global Angioedema Leadership Conference. March 30, 2026 | Interim data show sebetralstat enables early, effective treatment of hereditary angioedema (HAE) attacks in children with favorable safety and tolerability FRAMINGHAM, Mass. & SALISBURY, England-(BUSINESS WIRE)-KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new interim results from its KONFIDENT-KID clinical trial evaluating EKTERLY(R)(sebetralstat) for the on-demand treatment of hereditary angioedema (HAE) attacks in children ages 2-11 presented at the 2026 Global Angioedema Leadership Conference. KONFIDENT-KID is the largest pediatric trial ever conducted in HAE. It features a proprietary oral disintegrating tablet (ODT) formulation of sebetralstat in a population that currently relies on burdensome injectable treatments. The study was designed to enable compliance with treatment guidelines, consistent with the recently published "International Guideline on the Diagnosis and Management of Pediatric Patients with Hereditary Angioedema," which recommends ensuring on-demand treatment is available anytime, anywhere and prioritizes early intervention and rapid self-administration, regardless of attack severity or location. On-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID was presented by Emel Aygören-Pürsün, MD, University Hospital Frankfurt. * Among 172 HAE attacks in 33 pediatric participants treated using weight-based dosing of sebetralstat in a proprietary oral disintegrating tablet (ODT) formulation as of December 15, 2025: * Mean 0.7 attacks treated per patient per month * Median time to treatment of 25 minutes with 67% of attacks treated within the first hour; 88.9% were mild or moderate in severity * Median times to symptom relief and complete resolution (150 mg dose group, largest cohort) were 1.5 hours and 12 hours respectively * Sebetralstat was well tolerated with no serious or treatment-related adverse events, and no reports of difficulty swallowing. "Managing HAE attacks in children remains particularly challenging, as currently available on-demand treatments rely on injections or intravenous infusions that can be painful, anxiety-inducing, and difficult to administer promptly at symptom onset," said Dr. Aygören-Pürsün. "These barriers can contribute to treatment delays or avoidance, which may worsen outcomes. The KONFIDENT-KID data demonstrate that children and caregivers were able to treat attacks early and achieve rapid symptom relief with sebetralstat. This is especially meaningful in pediatric patients, where timely treatment can help limit swelling progression and reduce the overall duration and impact of an attack. An effective oral on-demand option has the potential to transform the treatment experience for children and families, reducing fear and burden while enabling early treatment of attacks." Currently, the only on-demand HAE treatment approved in the US for patients aged 2-11 is administered intravenously, highlighting a critical need for new therapeutic options. KalVista completed enrollment in the Phase 3 KONFIDENT-KID trial a full year ahead of schedule and expects to file a new drug application in the US in the third quarter of 2026 with a launch anticipated in 2027. If approved, sebetralstat would be the first and only oral on-demand therapy for pediatric patients aged 2-11 years and only the second FDA-approved on-demand therapy of any type in this population. "Each update from KONFIDENT-KID continues to build compelling evidence that sebetralstat has the potential to transform the treatment paradigm for children living with HAE," said Ben Palleiko, Chief Executive Officer of KalVista. "The rapid pace of enrollment and high attack treatment rate may signal a meaningful shift in treatment behavior with an oral on-demand option. Efficacy and safety outcomes remain consistent with those observed across the broader sebetralstat program, including rapid symptom relief and a favorable safety profile. These findings reinforce our confidence that sebetralstat is well-positioned to significantly reduce the burden of HAE and redefine how children and their caregivers manage attacks, and we are committed to bringing it to the community as quickly as possible." A link to the presentation is available on the KalVista website under Publications. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About KONFIDENT-KID KONFIDENT-KID is an open label clinical trial of sebetralstat for on-demand treatment of HAE attacks in pediatric patients. Originally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately enroll approximately 36 children aged 2-11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic and efficacy data for each patient for up to one year and features a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat. If approved, sebetralstat would be the first oral on-demand therapy for this age group, and only the second FDA-approved on-demand therapy of any type for this population. About EKTERLY(R)(sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2-11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information, visit EKTERLY.com. About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY(R)- the first and only oral on-demand treatment for hereditary angioedema (HAE) - and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "position," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY(R)(sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-KID trial, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our transition report on Form 10-KT for the transition period from May 1, 2025 to December 31, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Ryan Baker Head, Investor Relations (617) 771-5001 [email protected] Molly Cameron Senior Director, Corporate Affairs (978) 339-3378 [email protected]
KalVista Pharmaceuticals reported strong early commercial performance for EKTERLY, its oral hereditary angioedema treatment, with $35.4 million in fourth-quarter net revenue and $49.1 million from launch through 31 December 2025. The company recorded 1,702 patient start forms and 724 unique prescribers since the July 2025 US launch. CEO Benjamin Palleiko said refills now represent the majority of units and revenue, indicating continued patient use. Commercial lead Nicole Hester reported the company is adding approximately three new prescribers daily, with 29 of the top 30 US HAE prescribers writing multiple EKTERLY scripts. KalVista ended the period with $300 million in cash and reported a $112 million operating loss during an eight-month transition period. The company plans to submit a paediatric NDA in third quarter 2026 and has begun expansion in Germany and Japan.
KalVista Pharmaceuticals reported $49.1 million in global net product revenue for the eight months ended 31 December 2025, following the July launch of EKTERLY, the first oral on-demand therapy for hereditary angioedema. The company recorded 1,702 patient start forms in the US, representing nearly 20% of the patient population, and activated 724 unique prescribers through February 2026. EKTERLY has launched in Germany and Japan through partner Kaken Pharmaceutical, with additional market expansions planned for 2026. The company completed enrollment in its Phase 3 paediatric trial a year ahead of schedule and expects to file a US application in the third quarter of 2026. KalVista held £300.2 million in cash and marketable securities as of 31 December 2025 and anticipates reaching profitability with projected EKTERLY revenues.
KalVista to showcase new EKTERLY(R) data at 2026 Global Angioedema conference. KalVista Pharmaceuticals to showcase new clinical data on ekterly(r)(sebetralstat) at the 2026 Global Angioedema Leadership Conference. KalVista Pharmaceuticals has announced a significant scientific presence at the upcoming 2026 Global Angioedema Leadership Conference, highlighting its continued commitment to advancing treatment options for patients living with Hereditary Angioedema (HAE). The company revealed that five scientific abstracts - among them a notable late-breaking submission - have been accepted for presentation at the prestigious international meeting, which will take place from March 26 to 29, 2026, in Madrid. This strong representation underscores KalVista's growing leadership in the development of innovative therapies for HAE, particularly its investigational oral plasma kallikrein inhibitor, EKTERLY(R)(sebetralstat). The data to be presented span clinical efficacy, patient experience, and real-world treatment patterns, offering a comprehensive view of how emerging therapies may reshape disease management. Spotlight on late-breaking pediatric data. The centerpiece of KalVista's presentations is a late-breaking abstract focused on the use of oral sebetralstat in pediatric patients. Titled "On-demand Oral Sebetralstat for Hereditary Angioedema Attacks in Children Aged 2-11: Interim Analysis of KONFIDENT-KID," the study provides an early look at how this novel therapy performs in a younger population. The findings will be shared during a poster session on Friday, March 27, followed by an oral presentation on Saturday, March 28 at 11:50 a.m. CET - an indication of the importance and anticipated interest in the data. The KONFIDENT-KID study represents a critical step in expanding treatment access to children, a group that often faces limited therapeutic options and unique disease management challenges. Hereditary angioedema is characterized by recurrent, unpredictable episodes of severe swelling affecting various parts of the body, including the abdomen, extremities, face, and airway. In pediatric patients, the burden can be particularly significant, impacting quality of life, school attendance, and overall well-being. An effective oral, on-demand therapy could represent a major advancement over current injectable treatments, which can be difficult to administer and may cause distress in younger patients. Expanding insights from the KONFIDENT program. In addition to the pediatric study, KalVista will present multiple posters derived from its broader KONFIDENT clinical program, which evaluates sebetralstat across diverse patient populations and real-world scenarios. One of the key presentations, "On-demand Treatment Patterns of Hereditary Angioedema Attacks with Sebetralstat in the KONFIDENT-S Study," explores how patients are using the therapy in practice. This analysis provides valuable insights into treatment timing, frequency, and outcomes, helping clinicians better understand how oral therapies may integrate into routine care. The KONFIDENT-S study is particularly important because it reflects real-world usage patterns rather than strictly controlled clinical trial conditions. Such data are increasingly valued by healthcare providers and regulators alike, as they offer a more nuanced picture of how therapies perform outside of idealized settings. Addressing barriers to current therapies. Beyond clinical efficacy, KalVista is also shedding light on the practical and emotional challenges faced by patients with HAE. Two additional poster presentations draw on findings from international patient surveys, focusing on barriers to treatment and psychological impacts. The first survey-based study, "Barriers to Treatment of Hereditary Angioedema Attacks Among Patients Using Subcutaneous On-Demand Therapies," examines the obstacles patients encounter when relying on injectable treatments. These barriers may include difficulty with administration, delays in treatment, limited access, and concerns about side effects. Such findings highlight the unmet need for more convenient and accessible treatment options. Oral therapies like sebetralstat have the potential to address many of these issues by simplifying administration and enabling faster intervention during acute attacks. Understanding the emotional burden of HAE. The second survey presentation, "Anxiety in Patients Using Injectable On-Demand Treatments for Hereditary Angioedema Attacks," delves into the psychological dimension of living with HAE. Anxiety is a common yet often underrecognized aspect of the disease, driven by the unpredictability of attacks and the fear of severe outcomes, particularly those involving airway obstruction. For patients dependent on injectable therapies, anxiety may be compounded by concerns about timely access to treatment or the ability to self-administer during an attack. By capturing patient-reported experiences from an international cohort, this study adds an important human perspective to the clinical data. Together, these survey-based insights reinforce the broader value proposition of oral treatments - not only in terms of efficacy but also in improving patient confidence, independence, and quality of life. A comprehensive scientific presence. The breadth of KalVista's accepted abstracts reflects a multifaceted research strategy that goes beyond drug development to encompass patient experience, healthcare delivery, and real-world outcomes. By addressing both clinical and psychosocial aspects of HAE, the company is positioning itself at the forefront of patient-centered innovation in rare disease treatment. The Global Angioedema Leadership Conference serves as a key platform for researchers, clinicians, and industry leaders to share the latest advances in angioedema research and care. KalVista's prominent participation signals both the maturity of its clinical program and the growing anticipation surrounding sebetralstat as a potential first-in-class oral, on-demand therapy. Access to presentation materials. Following the conference, KalVista has indicated that links to all presentations will be made available through the Publications section of its corporate website. This will allow a broader audience - including clinicians, researchers, and patients - to access and review the findings presented in Madrid. As the field of hereditary angioedema continues to evolve, the need for more patient-friendly treatment options remains a central focus. KalVista's latest data presentations contribute to a growing body of evidence supporting the potential of oral therapies to transform the treatment landscape. With ongoing clinical development and increasing real-world insights, sebetralstat may represent a meaningful step forward in addressing both the clinical and everyday challenges faced by individuals living with HAE. The upcoming conference in Madrid is expected to further clarify its role and bring the medical community closer to a new standard of care in this rare but serious condition.
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Industries
Biotechnology
Healthcare
Company Size
201-500
Company Stage
IPO
Headquarters
Cambridge, Massachusetts
Founded
2011
Find jobs on Simplify and start your career today