Kalvista Pharmaceuticals Inc
NASDAQ:KALV
Kalvista Pharmaceuticals Inc
KalVista Pharmaceuticals, Inc. is a clinical stage pharmaceutical company, which engages in the discovery, development, and commercialization of small molecule protease inhibitors. The company is headquartered in Cambridge, Massachusetts and currently employs 70 full-time employees. The company went IPO on 2015-04-09. The firm is focused on the discovery, development and commercialization of small molecule protease inhibitors for diseases with unmet need. The firm has developed a portfolio of small molecule plasma kallikrein inhibitors targeting hereditary angioedema (HAE) and diabetic macular edema (DME). Plasma kallikrein is a serine protease enzyme, which is an early mediator of inflammation and edema. The body modulates the inflammatory effects of plasma kallikrein through a circulating inhibitor protein called C1-esterase inhibitor (C1-INH). The firm is primary focused on the development of the oral plasma kallikrein inhibitors for HAE. The company has two drug program candidates in clinical trials. The Company’s DME program is focused on the development of an intravitreally administered small molecule plasma kallikrein inhibitor, KVD001, which completed a Phase II trial.
KalVista Pharmaceuticals, Inc. is a clinical stage pharmaceutical company, which engages in the discovery, development, and commercialization of small molecule protease inhibitors. The company is headquartered in Cambridge, Massachusetts and currently employs 70 full-time employees. The company went IPO on 2015-04-09. The firm is focused on the discovery, development and commercialization of small molecule protease inhibitors for diseases with unmet need. The firm has developed a portfolio of small molecule plasma kallikrein inhibitors targeting hereditary angioedema (HAE) and diabetic macular edema (DME). Plasma kallikrein is a serine protease enzyme, which is an early mediator of inflammation and edema. The body modulates the inflammatory effects of plasma kallikrein through a circulating inhibitor protein called C1-esterase inhibitor (C1-INH). The firm is primary focused on the development of the oral plasma kallikrein inhibitors for HAE. The company has two drug program candidates in clinical trials. The Company’s DME program is focused on the development of an intravitreally administered small molecule plasma kallikrein inhibitor, KVD001, which completed a Phase II trial.
EKTERLY Approval: The FDA approved EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in July, with the U.S. launch starting immediately after approval.
Strong Launch Uptake: Early adoption has exceeded expectations, with almost 5% of the U.S. HAE population submitting prescriptions and 460 patient start forms received in the first 8 weeks.
Revenue Initiated: EKTERLY generated $1.4 million in net revenue for the quarter, reflecting initial stocking by specialty pharmacies.
Global Expansion: Regulatory progress continues outside the U.S., with positive opinions in Europe, UK approval, and anticipated approvals in Japan and Canada.
Commercial Execution: The company’s commercial infrastructure enabled rapid engagement with patients, physicians, and payers; 253 unique prescribers have already written for EKTERLY.
Access & Coverage: Formal U.S. coverage policies are expected to take up to 6 months, but some patients have already achieved paid access; 100% of early patients have received Quickstart access.
Financial Position: KalVista ended the quarter with $191 million in cash and investments, expected to fund operations into 2027.
Safety Profile: Early feedback on EKTERLY’s safety has been positive, with minimal adverse events and no GI-related issues reported.
