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Citizens JMP reiterated its Market Outperform rating and $19.00 price target on Kalvista Pharmaceuticals Inc (NASDAQ:KALV) Monday following an unexpected delay in the FDA approval process for sebetralstat. The stock has fallen 12.2% in the past week, though it maintains a 44.8% gain over the past six months, according to InvestingPro data.
The FDA cited resource constraints as the reason for the delay, indicating a decision would come in four weeks rather than extending the review period for three months. Kalvista management had been expecting to receive final label language on Friday. With analyst price targets ranging from $18 to $39, well above the current trading price of $12.96, market expectations remain optimistic despite the delay.
The research firm expressed confidence in sebetralstat’s approvability based on the clinical data package and noted the FDA had not requested additional data or studies, nor raised concerns about the drug’s safety, efficacy, or approvability.
Citizens JMP indicated approval could potentially come before the U.S. HAEA National Summit scheduled for July 10-13, which is expected to bring together approximately 1,000 HAE patients and would provide an opportunity to announce sebetralstat’s approval and availability.
The firm maintained its bullish stance on Kalvista, recommending investors continue buying shares, "especially on any weakness," given the unmet need in HAE treatment and sebetralstat’s clinical data.
In other recent news, KalVista Pharmaceuticals has experienced several noteworthy developments. The company announced a delay from the U.S. Food and Drug Administration (FDA) regarding the review of its oral treatment for hereditary angioedema (HAE), sebetralstat. The FDA cited workload and resource constraints as reasons for the delay, but no additional data or safety concerns were raised. Meanwhile, KalVista has secured a licensing agreement with Kaken Pharmaceutical (TADAWUL:2070) to commercialize sebetralstat in Japan, with an upfront payment of $11 million and potential additional payments upon regulatory approval.
Analysts at JMP Securities have maintained a Market Outperform rating for KalVista, expressing confidence in sebetralstat’s approval and emphasizing its potential as the first oral on-demand therapy for HAE. Stifel analysts also upheld their Buy rating, noting the strong efficacy and safety profile of sebetralstat demonstrated in phase 3 trials. Cantor Fitzgerald continues to rate KalVista as Overweight, highlighting the drug’s potential to become the preferred on-demand therapy for HAE due to its oral administration advantage.
KalVista’s management has outlined a comprehensive launch strategy for sebetralstat, which is under review by regulatory bodies in multiple regions, including the European Medicines Agency. The company aims to address the unmet medical needs of the HAE community with this innovative treatment. Investors are closely watching the upcoming FDA decision, which could significantly impact KalVista’s market performance and position in the HAE treatment landscape.
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