KalVista Pharma Licenses Sebetralstat For HAE To Kaken Pharma In Japan For Up To $22 Mln; Stocks Up

(RTTNews) - Shares of KalVista Pharmaceuticals, Inc. (KALV) were gaining around 5 percent in the pre-market activity on the Nasdaq, after the company announced Tuesday that its unit, KalVista Pharmaceuticals, Ltd., has licensed commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd. (KKPCF) for sebetralstat.

KalVista's lead investigational product sebetralstat is a novel, oral, on-demand treatment for hereditary angioedema or HAE.

Under the deal, KalVista will receive an upfront payment of $11 million, with an additional payment of up to $11 million upon achievement of a regulatory milestone anticipated in early 2026.

Beyond these payments, the company is also eligible for commercial milestone payments, plus royalties based on the Japan National Health Insurance (NHI) price, with the royalty rate as a percentage of sales approximately in the mid-twenties.

KalVista received Orphan Drug Designation for sebetralstat from Japan's Ministry of Health, Labour and Welfare or MHLW. The company has submitted a New Drug Application or NDA for sebetralstat in Japan. If approved, sebetralstat would be the first oral on-demand treatment for HAE in the country.

The company has filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, and are investigating its use in children aged 2 to 11.

Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, KalVista has completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency, and multiple other global regulatory authorities.

Ben Palleiko, CEO of KalVista, said, "This collaboration is an important part of our strategy to expand the global reach of sebetralstat as we prepare for several commercial launches starting this year. Our focus remains on delivering a safe and effective oral on-demand therapy that we believe will make a meaningful difference for people living with HAE worldwide."

In pre-market activity on the Nasdaq, KalVista shares are currently trading at $12.10, up 5.22%, after gaining around 7.4 percent on Monday's regular trading.

In Tokyo, Kaken Pharma closed Tuesday's trading at 4,465.00 yen, up 2.98%.

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