KalVista Announces Interim Results of EKTERLY Clinical Trial
KalVista Pharmaceuticals announced new interim results from its KONFIDENT-KID clinical trial evaluating EKTERLY for the on-demand treatment of hereditary angioedema 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 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 Aygoren-Pursun, 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 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 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. Aygoren-Pursun. "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."
Trade with 70% Backtested Accuracy
Analyst Views on KALV
About KALV
About the author
KALVISTA PHARMACEUTICALS INC - INITIAL DATA INDICATES SEBETRALSTAT PROVIDES PROMPT AND EFFICIENT TREATMENT FOR HAE IN CHILDREN
Study Findings: Interim data from Kalvista Pharmaceuticals indicates that their treatment for HA (Hereditary Angioedema) in children is both safe and effective.
Target Population: The research focuses on the early treatment of HA in pediatric patients, highlighting the importance of addressing this condition in children.
KalVista Reports Interim Results of EKTERLY Clinical Trial
- Clinical Trial Progress: KalVista Pharmaceuticals announced interim results from its KONFIDENT-KID trial involving 33 pediatric participants and 172 hereditary angioedema (HAE) attacks, demonstrating effective treatment with the oral dissolving tablet sebetralstat.
- Rapid Treatment Time: The data revealed a median time to treatment initiation of 25 minutes, with 67% of attacks treated within the first hour, indicating sebetralstat's ability to significantly reduce patient wait times and enhance treatment timeliness.
- Symptom Relief Efficacy: For the largest group receiving the 150 mg dose, symptoms began to improve in approximately 1.5 hours and completely resolved within 12 hours, showcasing the drug's rapid effectiveness in alleviating symptoms and boosting confidence among patients and caregivers.
- Future Outlook: KalVista plans to file a new drug application for sebetralstat in the US in Q3 2026, with a launch anticipated in 2027, reflecting the company's strong confidence in the drug's market potential, which could drive future revenue growth.
KALVISTA PHARMACEUTICALS INC: STIFEL INCREASES TARGET PRICE FROM $39 TO $42
- Price Increase Announcement: Stifel has raised the price target for KalVista Pharmaceuticals from $39 to $42.
- Market Implications: This adjustment reflects Stifel's updated outlook on KalVista's performance and potential in the pharmaceutical market.
KalVista Pharmaceuticals Reports 2025 Fiscal Year Performance
- Product Revenue Growth: KalVista Pharmaceuticals achieved $49.1 million in global net product revenue for the eight-month transition period ending December 31, 2025, including $35.4 million in the fourth quarter, indicating steady growth since the launch of EKTERLY, although still in the early stages.
- Rising Operating Expenses: The company's operating expenses surged to $160.2 million, a 43% increase from $117 million in the prior year, primarily driven by the costs associated with commercial launch activities, reflecting the high costs of market promotion.
- Reduced R&D Spending: Research and development expenses were $33.4 million, down 36% from $52.2 million in the prior year, indicating a more cautious spending strategy on new product development in response to current financial pressures.
- Strong Cash Position: As of December 31, 2025, KalVista reported $300 million in cash and investments, believed to be sufficient to fund operations under the current plan, although the company has not yet provided long-term financial guidance.
KalVista Reports $49.1 Million Revenue for EKTERLY® in Eight Months
- Revenue Growth: KalVista reported $49.1 million in global net product revenue for EKTERLY® (sebetralstat) for the eight months ending December 31, 2025, indicating strong market demand and rapid product adoption, which is expected to lay the groundwork for future profitability.
- Patient Initiation Metrics: By February 28, 2026, the company received 1,702 patient start forms in the US, representing nearly 20% of the total US patient population, and activated 724 unique prescribers, demonstrating EKTERLY's swift market penetration and acceptance.
- International Market Expansion: EKTERLY's launch in Japan, facilitated by partner Kaken Pharmaceutical Co., Ltd., has been listed on the National Health Insurance drug reimbursement price list, marking a significant step in the company's global market expansion and enhancing its international competitiveness.
- Significant Clinical Progress: The company completed enrollment in the KONFIDENT-KID Phase 3 trial for pediatric patients aged 2 to 11 a full year ahead of schedule, with plans to file a US new drug application in Q3 2026, further solidifying EKTERLY's position as a foundational therapy for HAE management.
KALVISTA PHARMACEUTICALS INC - ANNOUNCES EPS OF $-2.03 FOR THE EIGHT-MONTH PERIOD ENDING DECEMBER 31, 2025
Company Overview: Kalvista Pharmaceuticals is a biopharmaceutical company focused on developing treatments for diseases with high unmet medical needs.
Financial Report: The company reported earnings of $2.03 per share for the eight months ending December 31, 2025.
KALVISTA PHARMACEUTICALS INC - INITIAL DATA INDICATES SEBETRALSTAT PROVIDES PROMPT AND EFFICIENT TREATMENT FOR HAE IN CHILDREN
Study Findings: Interim data from Kalvista Pharmaceuticals indicates that their treatment for HA (Hereditary Angioedema) in children is both safe and effective.
Target Population: The research focuses on the early treatment of HA in pediatric patients, highlighting the importance of addressing this condition in children.
KalVista Reports Interim Results of EKTERLY Clinical Trial
- Clinical Trial Progress: KalVista Pharmaceuticals announced interim results from its KONFIDENT-KID trial involving 33 pediatric participants and 172 hereditary angioedema (HAE) attacks, demonstrating effective treatment with the oral dissolving tablet sebetralstat.
- Rapid Treatment Time: The data revealed a median time to treatment initiation of 25 minutes, with 67% of attacks treated within the first hour, indicating sebetralstat's ability to significantly reduce patient wait times and enhance treatment timeliness.
- Symptom Relief Efficacy: For the largest group receiving the 150 mg dose, symptoms began to improve in approximately 1.5 hours and completely resolved within 12 hours, showcasing the drug's rapid effectiveness in alleviating symptoms and boosting confidence among patients and caregivers.
- Future Outlook: KalVista plans to file a new drug application for sebetralstat in the US in Q3 2026, with a launch anticipated in 2027, reflecting the company's strong confidence in the drug's market potential, which could drive future revenue growth.
KALVISTA PHARMACEUTICALS INC: STIFEL INCREASES TARGET PRICE FROM $39 TO $42
- Price Increase Announcement: Stifel has raised the price target for KalVista Pharmaceuticals from $39 to $42.
- Market Implications: This adjustment reflects Stifel's updated outlook on KalVista's performance and potential in the pharmaceutical market.
KalVista Pharmaceuticals Reports 2025 Fiscal Year Performance
- Product Revenue Growth: KalVista Pharmaceuticals achieved $49.1 million in global net product revenue for the eight-month transition period ending December 31, 2025, including $35.4 million in the fourth quarter, indicating steady growth since the launch of EKTERLY, although still in the early stages.
- Rising Operating Expenses: The company's operating expenses surged to $160.2 million, a 43% increase from $117 million in the prior year, primarily driven by the costs associated with commercial launch activities, reflecting the high costs of market promotion.
- Reduced R&D Spending: Research and development expenses were $33.4 million, down 36% from $52.2 million in the prior year, indicating a more cautious spending strategy on new product development in response to current financial pressures.
- Strong Cash Position: As of December 31, 2025, KalVista reported $300 million in cash and investments, believed to be sufficient to fund operations under the current plan, although the company has not yet provided long-term financial guidance.
KalVista Reports $49.1 Million Revenue for EKTERLY® in Eight Months
- Revenue Growth: KalVista reported $49.1 million in global net product revenue for EKTERLY® (sebetralstat) for the eight months ending December 31, 2025, indicating strong market demand and rapid product adoption, which is expected to lay the groundwork for future profitability.
- Patient Initiation Metrics: By February 28, 2026, the company received 1,702 patient start forms in the US, representing nearly 20% of the total US patient population, and activated 724 unique prescribers, demonstrating EKTERLY's swift market penetration and acceptance.
- International Market Expansion: EKTERLY's launch in Japan, facilitated by partner Kaken Pharmaceutical Co., Ltd., has been listed on the National Health Insurance drug reimbursement price list, marking a significant step in the company's global market expansion and enhancing its international competitiveness.
- Significant Clinical Progress: The company completed enrollment in the KONFIDENT-KID Phase 3 trial for pediatric patients aged 2 to 11 a full year ahead of schedule, with plans to file a US new drug application in Q3 2026, further solidifying EKTERLY's position as a foundational therapy for HAE management.
KALVISTA PHARMACEUTICALS INC - ANNOUNCES EPS OF $-2.03 FOR THE EIGHT-MONTH PERIOD ENDING DECEMBER 31, 2025
Company Overview: Kalvista Pharmaceuticals is a biopharmaceutical company focused on developing treatments for diseases with high unmet medical needs.
Financial Report: The company reported earnings of $2.03 per share for the eight months ending December 31, 2025.
