KalVista Pharmaceuticals, Inc. (KALV)

In the past six months, KalVista Pharmaceuticals, Inc.'s stock price has been impacted by several events. On September 11, 2025, KalVista reported its Q1 2026 earnings, posting an EPS of -$1.12, missing analysts' expectations, and quarterly revenue was reported at $1.43 million, also falling below analysts' expectations, leading to a decline in KALV shares. Positive developments include the announcement on July 7, 2025, of the FDA approval of EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. In July, EKTERLY also received a positive CHMP opinion in Europe, with a final European Commission decision expected in October 2025. Additionally, on October 27, 2025, KalVista announced an update on an ongoing Phase 3 open-label clinical study evaluating the safety, pharmacokinetics, and efficacy of Sebetralstat (KVD900) in pediatric patients (ages 2-11) with HAE Type I or II.

The demand for KalVista Pharmaceuticals, Inc.'s products is not typically subject to seasonal fluctuations, as the need for HAE treatment is generally consistent year-round. No specific information suggests demand seasonality for KalVista's products or services.

KalVista Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing oral medicines for diseases with unmet needs, particularly rare diseases. The company specializes in drug therapies that inhibit plasma kallikrein and Factor XIIa. Its flagship product is EKTERLY (sebetralstat), an FDA-approved, orally delivered, small-molecule plasma kallikrein inhibitor designed for the on-demand treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged twelve years and older. The company is also developing Factor XIIa, an oral inhibitor for the treatment of HAE, which is currently in preclinical trials.

KalVista Pharmaceuticals, Inc. is headquartered in Cambridge, Massachusetts, US, with its original location in Cambridge, UK. The company has initiated the US launch of EKTERLY following its FDA approval. KalVista is making significant regulatory progress in Europe, with a positive CHMP opinion received in July 2025 for EKTERLY for the treatment of acute HAE attacks. A final European Commission decision is anticipated in October 2025, with a staged launch expected in Europe over the subsequent 12 to 18 months, commencing with Germany. The company is also assessing sebetralstat in an open-label extension study in Japan.

KalVista Pharmaceuticals has cultivated a reputation as a company dedicated to advancing science and empowering lives through innovative oral medicines, particularly for rare diseases like hereditary angioedema (HAE). The FDA approval of EKTERLY in July 2025 has significantly bolstered its reputation, positioning it to transform the treatment paradigm globally. Early uptake of EKTERLY in the US has been overwhelmingly positive, indicating strong market acceptance. The company's ongoing clinical studies further demonstrate its commitment to addressing unmet medical needs.

Major institutional and individual owners of KalVista Pharmaceuticals, Inc. include Vivo Ventures VI LLC, which is the largest individual shareholder, owning 8.41 million shares representing 16.64% of the company. Other significant owners include Vr Adviser LLC (13.32%) and Venrock Healthcare Capital Partners III LP (10.50%).