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CAMBRIDGE, Mass. - KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a $580 million market cap biotech company whose shares have gained nearly 38% year-to-date, announced Wednesday that its subsidiary has granted Pendopharm, a division of Pharmascience Inc., exclusive rights to manage regulatory approval and commercialization of sebetralstat in Canada.
Sebetralstat is an investigational oral treatment for hereditary angioedema (HAE), a rare genetic disease that causes painful and potentially life-threatening swelling in various body tissues. If approved, it would become the first oral on-demand treatment for HAE in Canada. According to InvestingPro data, seven analysts have recently revised their earnings expectations upward for KalVista, suggesting growing confidence in the company’s pipeline.
"We look forward to collaborating with Pendopharm, whose deep knowledge of the Canadian market and proven track record make them a strong partner," said Ben Palleiko, CEO of KalVista, according to the press release.
The financial terms of the agreement were not disclosed.
KalVista has filed multiple regulatory applications seeking approval for sebetralstat as the first oral on-demand treatment for HAE in individuals aged 12 and older. The company is also investigating its use in children aged 2 to 11.
Currently, all approved on-demand treatment options for HAE require either intravenous or subcutaneous administration. Sebetralstat, as an oral medication, could potentially transform HAE care by offering a more convenient treatment option.
Pendopharm, based in Canada, partners with various companies to bring treatments in areas such as rare diseases to the Canadian market. Its parent company, Pharmascience Inc., is one of Canada’s largest pharmaceutical manufacturers.
The information in this article is based on a press release statement from KalVista Pharmaceuticals. While the company maintains a strong liquidity position with a current ratio of 10.44, InvestingPro analysis reveals over 10 additional key insights about KalVista’s financial health and market position. Subscribers gain access to detailed financial metrics, Fair Value calculations, and expert analysis to make more informed investment decisions.
In other recent news, KalVista Pharmaceuticals has announced a delay in the FDA’s decision regarding its oral drug sebetralstat for hereditary angioedema (HAE). The FDA cited resource constraints as the reason for not meeting the original review deadline, but it expects to make a decision within approximately four weeks. Despite the delay, the FDA has not requested additional data or studies, nor raised any concerns about the drug’s safety, efficacy, or approvability. Meanwhile, KalVista presented new data at the European Academy of Allergy and Clinical Immunology Congress, showing sebetralstat’s effectiveness in treating HAE attacks in patients already on long-term prophylaxis therapy. In light of these developments, JMP Securities has reiterated its Market Outperform rating and $19 price target for KalVista, expressing confidence in the drug’s eventual approval. The firm noted that the FDA’s decision might coincide with the U.S. HAEA National Summit, providing an opportunity for a timely announcement. KalVista has also submitted marketing authorization applications to the European Medicines Agency and other global regulatory authorities. The company remains engaged in labeling discussions with the FDA, anticipating no approvability issues.
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