Durable Goods (Jun F) -9.4% vs 9.3% Prior, Ex-Trans 0.2% vs 0.2%
The U.S. Food and Drug Administration has delayed its decision on Kalvista Pharmaceuticals Inc’s (NASDAQ:KALV) oral drug sebetralstat for hereditary angioedema (HAE), the company announced Monday. The news impacted the company’s stock, which has seen a 12% decline over the past week, though it maintains a strong 45% gain over the last six months. According to InvestingPro data, the company currently has a market capitalization of $644 million. The FDA informed Kalvista on June 13 that it would not meet the original June 17 Prescription Drug User Fee Act (PDUFA) goal date.
The regulatory agency cited "heavy workload" and "limited resources" as reasons for the delay, according to Kalvista. The FDA expects to issue a regulatory decision within approximately four weeks from the original date. Despite the delay, InvestingPro analysis shows that 7 analysts have recently revised their earnings expectations upward for the upcoming period, suggesting continued confidence in the company’s prospects. InvestingPro subscribers have access to 10+ additional exclusive insights about KALV’s market position and financial health.
Kalvista emphasized that the FDA has not requested any additional data or studies, nor has the agency raised questions regarding the efficacy, safety, or approvability of sebetralstat. The company reported it is currently engaged in labeling discussions with the FDA.
The company received a minor information request about a week ago related to analyses of the two sebetralstat dosing arms in the Phase 3 clinical trial. Kalvista has completed this request and does not anticipate any approvability issues.
Sebetralstat is being developed as an oral on-demand treatment for HAE attacks, a rare condition that causes painful, potentially life-threatening swelling episodes. If approved, it would provide patients with a non-injectable option for acute HAE treatment. From a financial perspective, while the company holds more cash than debt on its balance sheet and maintains strong liquidity with a current ratio of 10.44, investors should note that the company is currently trading above its InvestingPro Fair Value.
In other recent news, KalVista Pharmaceuticals has presented promising data on its investigational oral treatment, sebetralstat, for hereditary angioedema (HAE) attacks. The data, shared at a European congress, demonstrated efficacy in patients already on long-term prophylaxis therapy. However, the U.S. Food and Drug Administration (FDA) has delayed its decision on the drug’s approval due to resource constraints, with a decision expected within four weeks. Despite the delay, Citizens JMP maintained its Market Outperform rating and $19 price target for KalVista, expressing confidence in the drug’s approvability based on the current clinical data.
In a strategic move, KalVista has also entered a licensing agreement with Kaken Pharmaceutical (TADAWUL:2070) to commercialize sebetralstat in Japan. This deal includes an upfront payment of $11 million, with potential additional payments and royalties contingent upon regulatory approval. The partnership aims to introduce the first oral on-demand HAE treatment in Japan, pending approval. Additionally, sebetralstat is under regulatory review in the U.S. and Europe, with the European Medicines Agency and other global bodies considering its applications. KalVista’s CEO expressed optimism about expanding the drug’s reach globally through these initiatives.
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