Bullish indicating open at $55-$60, IPO prices at $37
CAMBRIDGE, Mass. & TOKYO – KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) has entered into a licensing agreement with Kaken Pharmaceutical Co., Ltd. (JPX: 4521.T) to commercialize sebetralstat in Japan, a potential first oral treatment option for hereditary angioedema (HAE). Under the agreement, KalVista will receive an upfront payment of $11 million, with the potential for an additional $11 million upon regulatory approval, plus royalties from sales.
The partnership leverages Kaken's regional expertise in bringing innovative therapies to market, aiming to address the unmet medical needs of the HAE community in Japan. KalVista's CEO, Ben Palleiko, expressed confidence in Kaken's capabilities to successfully launch sebetralstat, which is part of the company's strategy to expand the drug's global reach. The market has responded positively to KalVista's developments, with the stock showing a strong 35% year-to-date return. InvestingPro analysis reveals that 7 analysts have revised their earnings expectations upward for the upcoming period, suggesting growing confidence in the company's prospects.
Sebetralstat has been granted Orphan Drug Designation by Japan's Ministry of Health, Labour and Welfare, with a New Drug Application currently under review. If approved, it would be the first oral on-demand treatment for HAE in Japan, providing a significant advancement in the management of this rare condition.
KalVista Pharmaceuticals focuses on developing oral therapies for rare diseases, with sebetralstat as its lead investigational product. The drug is also under regulatory review in the United States, with a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025, and has applications pending with the European Medicines Agency and other global regulatory bodies.
Kaken Pharmaceutical specializes in orthopedics and dermatology and is recognized for its innovative pharmaceutical developments in Japan. The collaboration is expected to enhance the quality of life for patients with HAE by introducing an oral treatment alternative.
This licensing agreement is a forward-looking statement and involves risks and uncertainties that may cause actual results to differ. KalVista and Kaken have not made any guarantees regarding the safety and efficacy of sebetralstat or its approval status. This news summary is based on a press release statement from KalVista Pharmaceuticals, Inc.
In other recent news, Kalvista Pharmaceuticals Inc. has been the focus of several analyst updates and company developments. Stifel analysts have maintained their Buy rating with a consistent price target of $39, following Kalvista's Investor Day event, which highlighted the commercial potential of sebetralstat, an oral treatment for hereditary angioedema (HAE) attacks. The analysts noted the promising phase 3 trial results and the absence of an Advisory Committee meeting, which they believe reduces regulatory approval risks. Cantor Fitzgerald also maintained an Overweight rating on Kalvista, expressing optimism about sebetralstat's potential to replace injectable treatments as the preferred on-demand therapy for HAE.
JMP analysts reiterated their Market Outperform rating with a $19 price target, projecting that sebetralstat's introduction could expand the U.S. on-demand HAE treatment market significantly. They estimate peak sales for sebetralstat at around $250 million, with potential revenue increases under certain pricing scenarios. Kalvista has also completed enrollment for its KONFIDENT-KID clinical trial, evaluating sebetralstat in pediatric patients, marking a significant step as the first oral on-demand therapy for this age group.
Additionally, H.C. Wainwright maintained a Buy rating with a $20 price target, citing the potential ease of use of sebetralstat compared to existing treatments that require injections. Analysts emphasized the ongoing demand for on-demand therapies, even with advancements in prophylactic treatments for HAE. Kalvista's management is preparing for a potential launch following the Prescription Drug User Fee Act (PDUFA) date set for June 17, 2025, with sebetralstat's approval anticipated to meet substantial market needs.
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