Kalvista stock jumps as Stifel reiterates Buy rating on Ekterly approval

Investing.com - Kalvista Pharmaceuticals Inc (NASDAQ:KALV) received a reiterated Buy rating and $39.00 price target from Stifel following the FDA approval of Ekterly (sebetralstat) for treating acute hereditary angioedema (HAE) in adults and adolescents. The stock, currently trading at $13.59, has significant upside potential according to analysts, with targets ranging from $18 to $39. InvestingPro data shows strong analyst consensus with 7 recent upward earnings revisions.

The approval comes with what Stifel describes as a "near-pristine label" for the 600mg dose, with no safety red flags or contraindications. The labeling language allows for more rapid re-dosing compared to competing drug Firazyr, which Stifel views as favorable for market adoption.

Kalvista has set Ekterly’s wholesale acquisition cost at approximately $17,000 per dose, higher than Stifel’s previous estimates. The firm notes that about 20% of patients may use two doses to treat an attack, according to management guidance.

The company plans to implement a quick-start program providing free medication to patients initially, meaning early launch metrics will focus more on demand than revenue generation.

Stifel expressed bullishness on both the product launch and Kalvista’s stock potential, suggesting "meaningful upside given modest buyside expectations" for the newly approved HAE treatment.

In other recent news, KalVista Pharmaceuticals announced the FDA’s approval of Ekterly (sebetralstat), marking the first oral treatment for hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval follows the successful phase 3 KONFIDENT trial, which showed Ekterly provides faster symptom relief and attack resolution compared to placebo. KalVista plans to launch Ekterly immediately in the U.S., supported by the KalVista Cares patient program. Additionally, KalVista has granted Pendopharm exclusive rights to manage the regulatory approval and commercialization of sebetralstat in Canada. The company is also conducting studies for children aged 2 to 11 and has regulatory applications under review in other global markets. Despite a recent delay in the FDA’s decision on sebetralstat due to resource constraints, KalVista reported no additional data requests or concerns about the drug’s efficacy or safety. Furthermore, new data presented at a medical congress highlighted sebetralstat’s efficacy in treating breakthrough HAE attacks in patients on long-term prophylaxis therapy. KalVista continues to engage in labeling discussions with the FDA and has submitted marketing applications to the European Medicines Agency and other regulatory bodies.

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