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CAMBRIDGE, Mass. - The U.S. Food and Drug Administration (FDA) has informed KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a $644 million market cap biotech company, that it will not meet the June 17 review deadline for sebetralstat, the company’s oral treatment for hereditary angioedema (HAE).
In a notice received Friday, the FDA cited "heavy workload and limited resources" for the delay but indicated it expects to deliver a decision within approximately four weeks, according to a press release statement from the company. The news triggered an 8.9% decline in KalVista’s stock price over the past week, though InvestingPro data shows the stock remains up over 50% in the past six months.
The FDA has not requested additional data or studies and has not raised concerns regarding the safety, efficacy, or approvability of sebetralstat. KalVista stated that it believes the only remaining item under review is the finalization of the drug’s labeling.
"We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks," said Ben Palleiko, CEO of KalVista.
Sebetralstat is being developed as the first oral, on-demand treatment for HAE in individuals aged 12 and older. HAE is a rare genetic disease that causes painful and sometimes life-threatening swelling in various parts of the body.
Currently, all approved on-demand treatments for HAE require either intravenous or subcutaneous administration. KalVista has submitted regulatory applications for sebetralstat in multiple countries, including a Marketing Authorization Application to the European Medicines Agency. While the company’s current price suggests overvaluation according to InvestingPro Fair Value metrics, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 10.44. Subscribers to InvestingPro can access 9 additional exclusive insights about KalVista’s financial health and market performance.
In other recent news, KalVista Pharmaceuticals has announced a significant licensing agreement with Kaken Pharmaceutical to commercialize its lead drug candidate, sebetralstat, in Japan. This partnership will provide KalVista with an upfront payment of $11 million and the potential for an additional $11 million upon regulatory approval, along with royalties from sales. Sebetralstat is currently under regulatory review in Japan and has been granted Orphan Drug Designation. Meanwhile, in the United States, the drug is also awaiting approval with a PDUFA date set for June 17, 2025. Analysts from JMP Securities have maintained a Market Outperform rating for KalVista, with a $19 price target, based on the anticipated approval of sebetralstat. Stifel analysts have echoed this sentiment, maintaining a Buy rating and a $39 price target, citing strong phase 3 trial results and a significant commercial opportunity for sebetralstat. Cantor Fitzgerald also expressed optimism with an Overweight rating, noting sebetralstat’s potential to replace injectable treatments for hereditary angioedema (HAE) attacks. Revenue projections for KalVista are set at $38 million, $159 million, and $299 million for fiscal years 2026, 2027, and 2028, respectively, with potential increases if sebetralstat is priced at $16,000 per attack.
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