KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company specializing in the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet medical needs. The company is primarily focused on developing treatments for hereditary angioedema (HAE), a rare genetic condition characterized by episodes of painful swelling. KalVista does not currently sell any products but is advancing its lead candidate, sebetralstat, through regulatory approval processes and conducting preclinical research on additional therapeutic programs.
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Sebetralstat - A novel, small molecule plasma kallikrein inhibitor being developed as the first oral, on-demand therapy for hereditary angioedema (HAE). The drug has completed the phase 3 KONFIDENT trial and is under regulatory review following the submission of a New Drug Application (NDA) in June 2024.
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Factor XIIa Inhibitor Program - A preclinical program focused on developing oral Factor XIIa inhibitors for next-generation HAE therapeutics. This program also explores potential applications in other diseases with high unmet medical needs.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Benjamin L. Palleiko Executive | Chief Executive Officer | None | Benjamin L. Palleiko is the CEO of KalVista Pharmaceuticals. He has also held roles as Principal Executive Officer, Principal Financial Officer, and Principal Accounting Officer. No external roles are listed. | View Report → |
Brian Piekos Executive | Chief Financial Officer | None | Brian Piekos joined KalVista as CFO in September 2024. He previously held CFO roles at Elicio Therapeutics and Gemini Therapeutics and has extensive experience in corporate finance and biopharma leadership. | |
Christopher M. Yea Executive | Chief Development Officer | None | Christopher M. Yea has been with KalVista since November 2015 as Chief Development Officer. He has extensive experience in drug development, previously serving as COO at Vantia, Ltd.. | |
Jeb Ledell Executive | Chief Operating Officer | None | Jeb Ledell became COO of KalVista in December 2024. He has over 20 years of experience in operational leadership, previously serving as COO at AVEO Pharmaceuticals and Enzyvant Therapeutics. | |
Paul K. Audhya Executive | Chief Medical Officer | None | Paul K. Audhya joined KalVista in May 2021 as CMO. He has held senior roles at Arena Pharmaceuticals, Vertex Pharmaceuticals, and Hospira, focusing on advancing KalVista's therapeutic programs. | |
Brian J. G. Pereira Board | Chairman of the Board | President & CEO of Visterra, Inc.; Board Member at ProKidney Corp., Visterra, Inc., and Africa Healthcare Network Ltd.; Director at America India Foundation; Adjunct Professor at Tufts University School of Medicine. | Brian J. G. Pereira has been Chairman of KalVista's Board since October 2022. He has extensive experience in biopharma leadership and academic roles, with a focus on rare diseases and healthcare innovation. | |
Edward W. Unkart Board | Director | None | Edward W. Unkart has been a director at KalVista since December 2014. He is a CPA with extensive experience in finance and accounting, having served on the boards of XTENT and VNUS Medical Technologies. | |
Laurence Reid Board | Director | Chair of the Board at Broken String Biosciences; Board Member at Garuda Therapeutics; Board Advisor to Life Science Cares and Mount Auburn Hospital. | Laurence Reid joined KalVista's Board in November 2024. He has over 30 years of experience in biopharma leadership, previously serving as CEO of Decibel Therapeutics and Warp Drive Bio. | |
Nancy Stuart Board | Director | Board Member at The Greater Boston YMCA. | Nancy Stuart has been a director at KalVista since March 2021. She has extensive experience in strategic planning and business operations, previously serving as COO at Concert Pharmaceuticals. | |
Patrick Treanor Board | Director | Board Member at XORTX Therapeutics. | Patrick Treanor joined KalVista's Board in May 2022. He has held senior commercial roles at Pathalys Pharma, Relypsa, and Insulet Corporation, focusing on operational leadership and commercialization. | |
William Fairey Board | Director | Board Member at Ascendis Pharma, Aileron Therapeutics, Mirum Pharmaceuticals, and Respira Therapeutics. | William Fairey joined KalVista's Board in April 2024. He has held senior commercial roles at MyoKardia, ChemoCentryx, and Actelion Pharmaceuticals, focusing on rare and specialty diseases. |
Research analysts covering KalVista Pharmaceuticals.
Recent press releases and 8-K filings for KALV.
- KalVista Pharmaceuticals reported $1.4 million in net revenue for the launch period of EKTERLY in Q1 2026, with total operating expenses of $60.4 million, including $45 million in SG&A primarily due to the EKTERLY launch.
- The company held approximately $191 million in cash and investments as of July 31, 2025, projecting this, along with forecasted EKTERLY revenue, to fund operations into 2027.
- EKTERLY received FDA approval on July 7, 2025, and its U.S. launch immediately followed, showing strong early uptake with 460 patient start forms and 253 unique prescribers by August 29.
- Global regulatory progress for EKTERLY includes a positive CHMP opinion in Europe, UK marketing authorization (with commercial launch anticipated in the first half of 2026), and expected approval in Japan by year-end 2025 for an early 2026 launch.
- KalVista Pharmaceuticals announced the FDA approval of ECTERLEET on July 7th, 2025, as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks, and immediately initiated its U.S. launch.
- For Q1 2026, ending July 31, 2025, the company reported $1.4 million in net revenue from initial ECTERLEET sales, primarily from stocking orders.
- Early U.S. launch metrics for ECTERLEET, through August 29, include 460 patient start forms and 253 unique prescribers activated.
- As of July 31, 2025, KalVista held approximately $191 million in cash and investments, which, combined with forecasted ECTERLEET revenue, is expected to fund operations into 2027.
- Internationally, ECTERLEET received a positive CHMP opinion in Europe, UK marketing authorization with anticipated commercial launch in H1 2026, and expected approval in Japan by year-end with launch in early 2026.
- KalVista Pharmaceuticals announced FDA approval of ECTERLEET on July 7th as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks, initiating its U.S. launch immediately.
- For the first fiscal quarter ending July 31, 2025, the company reported $1.4 million in net revenue from initial ECTERLEET sales, primarily from stocking orders. Early U.S. launch metrics through August 29th include 460 patient start forms received and 253 unique prescribers activated.
- As of July 31, 2025, KalVista had $191 million in cash and investments, which is expected to fund operations into 2027.
- The company is also progressing with international regulatory efforts for ECTERLEET, including a positive CHMP opinion in Europe, MHRA marketing authorization in the UK, and anticipated approval in Japan by the end of 2025.
- KalVista Pharmaceuticals announced the FDA approval of ECTERLEET on July 7th and immediately initiated its U.S. launch as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 and older.
- For the three-month period ending July 31st, 2025, the company reported $1.4 million in net revenue from initial ECTERLEET sales.
- Early U.S. launch metrics for ECTERLEET include 460 patient start forms received and 253 unique prescribers activated in the eight-week period ending August 29.
- As of July 31st, 2025, KalVista had approximately $191 million in cash and investments, which, combined with forecasted ECTERLEET revenue, is expected to fund operations into 2027.
- Internationally, ECTERLEET received a positive CHMP opinion in Europe in July, with a final European Commission decision expected in October, and UK marketing authorization, anticipating launches in Europe over the next 12 to 18 months and the UK in the first half of 2026.
- KalVista Pharmaceuticals reported $1.4 million in net product revenue for the fiscal quarter ended July 31, 2025, primarily from US sales of EKTERLY, and a net loss of $60.1 million for the same period.
- The company initiated the US commercial launch of EKTERLY (sebetralstat) on July 7, 2025, following FDA approval, and received 460 patient start forms through August 29, 2025.
- EKTERLY also received marketing authorization in the United Kingdom in July 2025, and the European Medicines Agency (EMA) adopted a positive opinion recommending approval of sebetralstat, with a final decision expected in October 2025.
- As of July 31, 2025, KalVista had $191.5 million in cash, cash equivalents, and marketable securities, providing a runway into 2027.
- KalVista Pharmaceuticals announced the maintenance of orphan designation for sebetralstat in the European Union (EU).
- This designation provides 10 years of market exclusivity in the EU if sebetralstat is approved.
- Sebetralstat, an oral plasma kallikrein inhibitor, has received a positive CHMP opinion for the treatment of acute attacks of hereditary angioedema (HAE), with the European Commission's final decision expected by early October.
- Sebetralstat is already approved in the United States and United Kingdom under the brand name EKTERLY® for the treatment of HAE attacks.
- KalVista Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat for the symptomatic treatment of acute hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older in the European Union (EU).
- If approved, sebetralstat is expected to be the first and only oral on-demand treatment for HAE in Europe.
- The European Commission (EC) is anticipated to make its final decision on marketing authorization by early October 2025.
- Sebetralstat has already received regulatory approvals in the United States and United Kingdom.
- KalVista Pharmaceuticals, Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for EKTERLY® (sebetralstat), making it the first and only oral on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older in the UK.
- EKTERLY will be added to the Orphan Register and awarded 10 years of market exclusivity in the UK.
- This UK approval follows the U.S. Food and Drug Administration (FDA) approval for EKTERLY on July 3, 2025.
- The MHRA's marketing authorization is based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE.
- KalVista Pharmaceuticals announced FDA approval of EKTERLY (sebetralstat) on July 7, 2025, making it the first and only oral on-demand treatment for hereditary angioedema (HAE), with a U.S. launch underway.
- As of April 30, 2025, the company reported $220.6 million in cash, cash equivalents, and marketable securities, providing a financial runway into 2027.
- For the fiscal year ended April 30, 2025, KalVista reported a net loss of $(183.444) million , with general and administrative expenses increasing to $116.3 million due to pre-commercial planning for EKTERLY.
- The company has entered into licensing agreements for sebetralstat commercialization in Japan and Canada, and has six additional global regulatory submissions under review.
- The FDA has pushed the sebetralstat review decision approximately four weeks past the original June 17, 2025 goal date due to resourcing constraints, without requesting additional data or raising safety concerns.
- Final label approval is expected to be the last regulatory step, and KalVista’s management remains optimistic about imminent approval.
- Wall Street analysts maintain an average one-year price target of $27.25, implying over 110% upside from the current stock price of $12.96.
- DRI Healthcare Trust, which holds royalty interests in sebetralstat, retains a Hold rating with a C$15.00 price target and is classified as Neutral amid profitability challenges.