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On Wednesday, Kalvista Pharmaceuticals Inc (NASDAQ:KALV), currently trading at $12.30 with a market capitalization of $611.5 million, maintained its Market Outperform rating and $19.00 price target from JMP Securities. The firm’s analyst expressed confidence in Kalvista’s lead drug candidate, sebetralstat, anticipating approval by the upcoming June 17 PDUFA date. The optimism is based on a 90% probability of success (POS) for the drug, which aims to be the first oral on-demand therapy for hereditary angioedema (HAE). According to InvestingPro data, analyst targets for the stock range from $18 to $39.
Kalvista’s management team has already detailed their launch strategy for sebetralstat, which they discussed at a recent commercial presentation. The analyst from JMP Securities believes that the company is well-equipped to implement this strategy effectively upon the drug’s approval. InvestingPro data reveals that 7 analysts have revised their earnings upwards for the upcoming period, suggesting growing confidence in the company’s prospects.
The biotech firm’s stock performance has been notable this year, with shares appreciating 45.22% year to date according to InvestingPro data. This growth is attributed to positive investor sentiment around the potential approval and launch of sebetralstat. The company maintains a strong liquidity position with a current ratio of 10.44, indicating robust short-term financial health.
The analyst anticipates that the stock could continue to climb as the PDUFA date approaches. The early launch of sebetralstat may surpass initial expectations due to the possibility of premium pricing and swift market adoption, mirroring the success of the first oral drug in the prophylactic setting for HAE.
Investors and market watchers are now eyeing the June 17 decision date, which could mark a significant milestone for Kalvista Pharmaceuticals and potentially reinforce the company’s strong performance in the stock market this year.
In other recent news, KalVista Pharmaceuticals has entered into a licensing agreement with Kaken Pharmaceutical (TADAWUL:2070) to commercialize sebetralstat in Japan, potentially offering the first oral treatment for hereditary angioedema (HAE) in the region. KalVista will receive an upfront payment of $11 million, with an additional $11 million contingent on regulatory approval, plus royalties from sales. Sebetralstat, which has been granted Orphan Drug Designation in Japan, is currently under regulatory review, with the potential to become a significant advancement in HAE management. Additionally, KalVista has completed enrollment for its KONFIDENT-KID clinical trial, which aims to evaluate sebetralstat as an oral treatment for children aged two to 11 with HAE. This trial marks a significant step as the first oral on-demand therapy for this age group, with results expected later this year.
Stifel analysts have maintained their Buy rating for KalVista, citing strong efficacy and safety results from phase 3 trials of sebetralstat. The analysts believe the absence of an Advisory Committee meeting reduces regulatory risk, and they see a substantial commercial opportunity for the drug. Cantor Fitzgerald also maintains an Overweight rating, highlighting sebetralstat’s potential to replace injectable treatments as the preferred on-demand therapy for HAE. JMP analysts reiterated their Market Outperform rating, forecasting that sebetralstat could significantly expand the U.S. on-demand market for HAE treatments. They predict U.S. peak sales for the drug could reach around $250 million, with revenue projections set at $38 million, $159 million, and $299 million for fiscal years 2026, 2027, and 2028, respectively.
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