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Investing.com - Kalvista Pharmaceuticals Inc (NASDAQ:KALV) received a price target increase from Leerink Partners to $20.00 from $18.00, with the firm maintaining its Outperform rating following FDA approval of the company’s hereditary angioedema (HAE) treatment. The stock has surged nearly 37% over the past six months and currently trades near its 52-week high of $15.50. According to InvestingPro data, the company appears overvalued at current levels.
The FDA approved Ekterly (sebetralstat) as the first orally administered on-demand therapy for HAE attacks, with a broad label that places no restrictions on attack severity or anatomical location. This approval marks a significant milestone as the first oral medication for treating HAE attacks.
Kalvista has set Ekterly’s wholesale acquisition cost (WAC) at $16,720 per dose, slightly below Leerink’s previous estimate of $20,000 gross. The medication will be packaged with four 300mg tablets, enough to treat two HAE attacks.
The company has completed commercial preparations and launched patient support programs, with sales representatives reportedly visiting physician offices immediately following approval. Kalvista has implemented both a Quick Start program and a patient support service called KalVista Cares.
Beyond the U.S. market, Kalvista anticipates an EMA decision and targeted launch in Germany during the second half of 2025, followed by launches in Japan and the United Kingdom (TADAWUL:4280) next year. Analyst consensus remains bullish, with price targets ranging from $19 to $39. Discover more exclusive insights and 12 additional ProTips with InvestingPro.
In other recent news, KalVista Pharmaceuticals announced the FDA approval of Ekterly (sebetralstat), marking it as the first oral on-demand treatment for hereditary angioedema (HAE) in patients aged 12 and older. This approval is based on the phase 3 KONFIDENT trial, which demonstrated significantly faster symptom relief and attack resolution compared to placebo. KalVista plans to launch Ekterly immediately in the U.S., with physicians able to start writing prescriptions. The company has also established KalVista Cares, a patient support program to assist with insurance navigation and access support. In response to the approval, BofA Securities raised its price target for KalVista to $37 while maintaining a Buy rating, citing Ekterly’s unique position in the market. Stifel reiterated its Buy rating with a $39 price target, noting the favorable market adoption prospects due to the drug’s rapid re-dosing capability. Additionally, KalVista granted Pendopharm exclusive rights to manage regulatory approval and commercialization of sebetralstat in Canada, potentially making it the first oral on-demand treatment for HAE in the country. The financial terms of this agreement were not disclosed.
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