Leerink Partners holds Outperform on Kalvista stock, expects strong peak sales potential

On Friday, Leerink Partners maintained a positive outlook on Kalvista Pharmaceuticals Inc (NASDAQ:KALV), reiterating an Outperform rating and a $20.00 price target.

The firm updated its model following Kalvista's first-quarter financial results and corporate update, which included the FDA's acceptance of the New Drug Application (NDA) for sebetralstat, an oral treatment for hereditary angioedema (HAE). The Prescription Drug User Fee Act (PDUFA) goal date for sebetralstat is set for June 17, 2025.

The FDA's recent decision to accept the NDA for sebetralstat under standard review, without the need for an Advisory Committee meeting, marks a significant step forward for Kalvista. The company aims to launch the drug in 2025, expecting gross peak sales of approximately $470 million across the US and European markets by 2036. These projections are based on a 90% probability of success and estimated peak market penetration rates in the US and EU.

Kalvista's progress is underscored by the KONFIDENT study's positive top-line data released in February 2024, which led to the NDA submission in June of the same year. The demand for a convenient oral therapy option for HAE is high, with over 65% of survey respondents indicating a preference for such treatments due to ease of use and administration.

The company's global expansion plans include a recently validated Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) and expected filings in the UK, Japan, and other countries later in 2024. Additionally, Kalvista has initiated a pediatric trial for sebetralstat and plans to start a study for adolescent and adult patients in the fourth quarter of 2024. Positive outcomes from these trials could potentially broaden sebetralstat's label, making it the second approved on-demand therapy for pediatric patients with HAE.

In other recent news, KalVista Pharmaceuticals (NASDAQ:KALV) has made notable progress in the development of sebetralstat, an investigational oral treatment for hereditary angioedema (HAE).

Sebetralstat demonstrated a safety profile comparable to a placebo and provided rapid symptom relief in phase 2 and phase 3 clinical trials. The U.S. FDA has accepted the New Drug Application (NDA) for sebetralstat and set a review date of June 17, 2025. In addition, the European Medicines Agency (EMA) has started reviewing the Marketing Authorization Application (MAA) for sebetralstat, signaling progress towards introducing the drug to the European market.

Analyst firm H.C. Wainwright has maintained a Buy rating on KalVista, expressing optimism around the company's recent NDA submission for sebetralstat. Furthermore, KalVista has secured a lease for new corporate headquarters and laboratory space in Framingham, MA, reflecting the company's growth strategy.

InvestingPro Insights

As Kalvista Pharmaceuticals Inc (NASDAQ:KALV) prepares for the potential launch of sebetralstat, an oral treatment for hereditary angioedema, financial metrics and analyst insights from InvestingPro provide a broader context for investors. With a market capitalization of approximately $554.46 million and a P/E ratio signaling that the company is not currently profitable, Kalvista holds more cash than debt, which is a positive sign for its financial health. However, it's important to note that the company is quickly burning through cash, which could impact its long-term operations.

InvestingPro Tips highlight that analysts have revised their earnings expectations downwards for the upcoming period and do not anticipate the company will be profitable this year. This information could be crucial for investors considering the potential risks and rewards associated with Kalvista's stock. Additionally, the company's gross profit margins have been weak over the last twelve months, and net income is expected to drop this year.

For those interested in further analysis and metrics, InvestingPro offers additional tips on Kalvista Pharmaceuticals Inc, which can be found at https://www.investing.com/pro/KALV. These insights could provide valuable guidance as the company navigates the regulatory process and plans for the commercialization of its HAE treatment.

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