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CAMBRIDGE, Mass. - The U.S. Food and Drug Administration has approved Ekterly (sebetralstat), the first oral treatment for acute attacks of hereditary angioedema (HAE) in patients aged 12 and older, KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) announced Monday. The biotech company, currently valued at approximately $596 million, has seen its stock surge over 36% in the past six months. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently burning through cash reserves.
Ekterly represents the first new on-demand HAE treatment in over a decade and the first that can be taken by mouth. Previously approved treatments required intravenous or subcutaneous administration.
The approval was based on results from the phase 3 KONFIDENT trial, which demonstrated that Ekterly provided significantly faster symptom relief and attack resolution compared to placebo. Data from the trial was published in the New England Journal of Medicine in May 2024.
"This is an important moment for patients, giving people living with HAE a treatment option that could provide greater independence and control over managing their condition," said Marc A. Riedl, Professor of Medicine at the University of California, San Diego, and an investigator for the KONFIDENT trial.
The KONFIDENT-S open-label extension trial showed that patients were able to treat attacks within a median of 10 minutes following onset, with symptom relief beginning in a median of 1.3 hours for various attack types. The most common side effect reported was headache.
HAE is a rare genetic disease characterized by painful and sometimes life-threatening swelling in various parts of the body. Treatment guidelines recommend addressing attacks as early as possible.
KalVista said it will launch Ekterly immediately in the U.S. and has established KalVista Cares, a patient support program to assist with insurance coverage and access. Seven analysts have recently revised their earnings expectations upward for the upcoming period, with price targets ranging from $18 to $39 per share, as revealed by InvestingPro analysis. The platform offers 9 additional exclusive insights about KalVista’s financial health and market position.
The company is currently conducting studies in children aged two to 11 and has regulatory applications under review in other global markets, according to the press release statement. With a robust current ratio of 10.44, KalVista appears well-positioned to fund its ongoing research and development efforts, though InvestingPro analysis indicates the company is currently trading slightly above its Fair Value.
In other recent news, KalVista Pharmaceuticals announced that its subsidiary has granted Pendopharm exclusive rights to manage regulatory approval and commercialization of sebetralstat in Canada. Sebetralstat is an investigational oral treatment for hereditary angioedema (HAE) and, if approved, would be the first oral on-demand treatment for HAE in the country. Meanwhile, the U.S. Food and Drug Administration has delayed its decision on sebetralstat due to resource constraints, expecting to provide a decision within approximately four weeks from the original deadline. Despite the delay, the FDA has not requested additional data or raised concerns about the drug’s safety or efficacy. KalVista is currently in discussions with the FDA regarding the drug’s labeling. Additionally, new data presented at the European Academy of Allergy and Clinical Immunology Congress showed sebetralstat effectively treats HAE attacks in patients on long-term prophylaxis therapy. Citizens JMP has reiterated its Market Outperform rating and $19 price target on KalVista, expressing confidence in the drug’s approvability. KalVista has also submitted applications for sebetralstat to the European Medicines Agency and other global regulatory authorities.
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