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KalVista Pharmaceuticals (KALV)

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Earnings summaries and quarterly performance for KalVista Pharmaceuticals.

Recent press releases and 8-K filings for KALV.

KalVista's Ekterly Receives First-Line Recommendation in International HAE Guideline
KALV
Product Launch
New Projects/Investments
  • An international guideline strongly recommends sebetralstat (Ekterly) as a first-line, on-demand oral treatment for acute hereditary angioedema (HAE) attacks in patients aged 12 and older.
  • This recommendation is based on robust clinical trial evidence, including Phase 3 KONFIDENT data showing faster symptom relief and rapid attack resolution, along with a favorable safety profile.
  • Ekterly is the first and only oral on-demand option for patients aged 12 and older, having received regulatory approvals in seven jurisdictions and launched in the United States and Germany in 2025.
  • KalVista plans to seek approval for children aged 2–11, targeting a submission in the third quarter of 2026.
Feb 18, 2026, 12:15 PM
KalVista Pharmaceuticals' EKTERLY Recommended as First-Line Therapy for Pediatric HAE
KALV
Product Launch
New Projects/Investments
  • KalVista Pharmaceuticals announced that its drug, EKTERLY® (sebetralstat), is recommended as a first-line therapy for the acute treatment of hereditary angioedema (HAE) attacks in adolescents aged 12 and older by a newly published international guideline.
  • This recommendation is based on robust, high-quality evidence, including clinical trial data demonstrating consistent efficacy, rapid symptom relief, and a favorable safety profile.
  • EKTERLY is the first and only oral on-demand treatment for people 12 and older with HAE, supporting early intervention and rapid self-administration.
  • The drug received seven global regulatory approvals in 2025 and is currently marketed in the US and Germany, with additional global launches anticipated in 2026 and beyond.
  • KalVista is advancing the KONFIDENT-KID trial for HAE patients aged 2 to 11 and plans to submit a new drug application for this age group in the third quarter of 2026.
Feb 18, 2026, 12:00 PM
KalVista Pharmaceuticals Launches EKTERLY in US and Germany, Reports Strong Initial Sales
KALV
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • KalVista Pharmaceuticals has launched EKTERLY (sebetralstat), the first and only oral on-demand therapy for hereditary angioedema (HAE), in the US and Germany, with approvals in seven key global markets including the US, EU, UK, Switzerland, Australia, Japan, and Singapore.
  • From its US launch on July 7, 2025, through December 31, 2025, EKTERLY generated ~$49M in unaudited global net product revenue, with 1,318 patient start forms received and 580 unique prescribers in the US.
  • The company is pursuing a pediatric expansion for EKTERLY, with an NDA filing for children aged 2-11 years expected in Q3 2026 and an anticipated launch in 2027.
  • KalVista aims to expand its portfolio by developing, acquiring, or in-licensing additional innovative therapies for rare diseases, supported by a strong financial foundation and IP protection into the 2040s.
  • The current U.S. HAE market is valued at $650M, with a total addressable market of $1.5B with branded pricing and increased treatment rates, which EKTERLY is poised to capture.
Jan 9, 2026, 12:00 PM
KalVista Pharmaceuticals Reports Preliminary Q4 and Full Year 2025 EKTERLY Revenue
KALV
Earnings
Product Launch
Revenue Acceleration/Inflection
  • KalVista Pharmaceuticals announced preliminary unaudited global net product revenue for EKTERLY of approximately $35 million for the fourth quarter of 2025 and $49 million for the full year 2025.
  • Since its US commercial launch on July 7, 2025, EKTERLY has received 1,318 patient start forms and activated 580 unique prescribers in the US through December 31, 2025.
  • The company is experiencing strong early adoption in Germany and plans to expand into other major markets during 2026, including a partnership with Multicare Pharma to commercialize sebetralstat in Latin America.
  • KalVista expects to file a new drug application for pediatric HAE patients aged 2-11 years in the third quarter of 2026, with a US launch anticipated in 2027.
Jan 8, 2026, 9:47 PM
KalVista Pharmaceuticals Provides Preliminary Q4 and Full Year 2025 EKTERLY Revenue Results
KALV
Earnings
Product Launch
New Projects/Investments
  • KalVista Pharmaceuticals reported unaudited global net product revenue for EKTERLY of approximately $35 million for the fourth quarter and $49 million for the full year 2025.
  • The US commercial launch of EKTERLY, initiated on July 7, 2025, has resulted in 1,318 patient start forms and 580 unique prescribers in the US through December 31, 2025.
  • EKTERLY, approved in seven global markets, has demonstrated strong early adoption in Germany, and KalVista has partnered with Multicare Pharma for commercialization in Latin America.
  • KalVista expects to file a new drug application for EKTERLY in pediatric HAE patients aged 2-11 years in the third quarter of 2026, with a US launch anticipated in 2027.
Jan 8, 2026, 9:05 PM
KalVista Pharmaceuticals Announces Japanese Approval for EKTERLY®
KALV
Product Launch
  • KalVista Pharmaceuticals announced the marketing and manufacturing approval of EKTERLY® (sebetralstat) in Japan by the Ministry of Health, Labor and Welfare (MHLW).
  • EKTERLY is the first and only oral on-demand treatment for acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older approved in Japan.
  • Kaken Pharmaceutical Co., Ltd. will commercialize EKTERLY in Japan, with a launch planned shortly after its listing on the Japanese National Health Insurance System (NHI).
  • This approval, based on the phase 3 KONFIDENT clinical trial, marks the seventh regulatory approval for EKTERLY across major global markets since July 3, 2025.
Dec 22, 2025, 11:00 AM
KalVista Provides Update on Ekterly Launch and Market Penetration
KALV
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • KalVista Pharmaceuticals launched Ekterly, the first oral therapy for on-demand treatment of acute HAE attacks, in July following FDA approval.
  • The company has seen rapid uptake, with over 1,000 patients on therapy, representing comfortably over 10% of the marketplace.
  • KalVista reported $13.7 million in revenue last quarter, primarily reflecting actual end-user demand, with severe disease patients showing high refill frequency (e.g., three to four weeks).
  • The company anticipates maintaining market leadership despite upcoming competitor data, citing Ekterly's early market entry, high patient satisfaction, and the distinct design of its clinical trials.
  • International expansion includes a first shipment to Germany in October, with planned launches in the U.K. in H1 2026 and Japan in Q1 2026, though XUS markets are expected to price at a fraction of U.S. pricing (e.g., 20% of U.S. price).
Nov 19, 2025, 1:30 PM
KalVista Pharmaceuticals Provides Update on EKTERLY Launch and Commercialization
KALV
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • KalVista Pharmaceuticals launched EKTERLY, an oral therapy for acute HAE attacks, in July following FDA approval, marking a substantial advance in treatment.
  • As of November 2025, over 1,000 patients are on EKTERLY therapy, representing 12-13% of the marketplace, with rapid uptake.
  • The company reported $13.7 million in revenue last quarter, primarily driven by end-user demand for EKTERLY.
  • International expansion plans include the first shipment to Germany in October, with launches expected in the U.K. in H1 2026 and Japan in Q1 2026; XUS markets are projected to contribute 20% of global revenue long-term.
  • KalVista does not anticipate upcoming Pharvaris Phase 3 data to impact EKTERLY's commercial trajectory due to significant differences in study design and EKTERLY's established market position.
Nov 19, 2025, 1:30 PM
KalVista Pharmaceuticals Discusses EKTERLY Launch and Market Trajectory
KALV
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • KalVista Pharmaceuticals launched EKTERLY, an oral therapy for the on-demand treatment of acute attacks of HAE, in July after FDA approval.
  • As of November 19, 2025, over 1,000 patients are on therapy, representing 12%-13% of the marketplace, with 937 start forms reported earlier, indicating extraordinarily fast uptake.
  • The company reported $13.7 million in revenue for the last quarter, primarily reflecting actual end-user demand for EKTERLY.
  • Refills are evolving, with severe disease patients (15%-20% of the total patient population) refilling at a high frequency of three to four weeks, often with multiple cartons.
  • International launches include the first shipment to Germany in October, with planned launches in the U.K. in the first half of 2026 and Japan in the first quarter of 2026.
Nov 19, 2025, 1:30 PM
KalVista Pharmaceuticals Reports Strong Initial Commercial Performance for EKTERLY
KALV
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • KalVista Pharmaceuticals reported its first full commercial quarter for EKTERLY, the first and only oral therapy for HAE attacks, following its approval on July 3 and launch on July 7.
  • The launch has demonstrated strong uptake, with 10%-12% of patients converting to EKTERLY in less than four months, resulting in revenues meaningfully exceeding expectations.
  • The company is consistently adding approximately 200-220 new patients per month, with early adopters largely being high-attack rate patients who show higher refill rates.
  • Payer coverage is developing as anticipated, with major formularies expected by early 2026, and international expansion is underway, including a successful launch in Germany.
  • KalVista plans to grow into a leading rare disease commercial entity, with an NDA filing for the pediatrics indication anticipated in Q3 next year.
Nov 12, 2025, 1:40 PM

Quarterly earnings call transcripts for KalVista Pharmaceuticals.