KalVista Pharmaceuticals (KALV) Received Positive Opinion From the European Medicines Agency

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) is one of the Stocks With Huge Catalysts on the Horizon. On July 25, KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) announced that its oral drug Sebetralstat received a positive opinion from the European Medicines Agency’s CHMP.

Sebetralstat treats acute attacks of hereditary angioedema in patients 12 years and older. Management noted that the final decision from the European Commission is expected by early October 2025. If approved, the drug would be the first and only oral on-demand treatment for hereditary angioedema available in Europe.

The positive opinion by CHMP is based on results from the phase 3 KONFIDENT clinical trial, which was the largest trial ever for HAE, involving 136 patients in 20 countries. The results showed that the drug provided rapid symptom relief, reduced attack severity, and was well-tolerated with a safety profile similar to placebo. Sebetralstat is already approved in the US and UK under the brand name EKTERLY.

KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) is focused on developing treatments for diseases with high unmet need, especially hereditary angioedema.

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Disclosure: None. This article is originally published at Insider Monkey.