EMERYVILLE, Calif. - Dynavax (NASDAQ:DVAX) Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company's supplemental Biologics License Application (sBLA) for a four-dose regimen of its HEPLISAV-B® vaccine for adults on hemodialysis.
The FDA's letter indicated that the application's supporting data were inadequate for a full evaluation of the vaccine's effectiveness and safety in this specific regimen.
The CRL does not affect the current approvals for HEPLISAV-B in the United States, the European Union, and Great Britain, where the vaccine is indicated for the prevention of hepatitis B in adults aged 18 and older. Similarly, the decision does not impact the European Commission's approval in October 2023 for the four-dose regimen for adults undergoing hemodialysis.
According to the CRL, the data from the Phase 1 HBV-24 study, which involved 119 adults on hemodialysis, were insufficient. This was partly due to the destruction of data source documents for about half of the trial's participants by a third-party clinical site operator. The FDA also found the number of subjects in the study insufficient for a proper safety evaluation.
Dynavax's Chief Medical Officer, Dr. Rob Janssen, stated, "We remain confident in the data generated to support HEPLISAV-B vaccination for adult hemodialysis patients." The company plans to request a meeting with the FDA to discuss additional data that could support approval for the four-dose regimen.
The HEPLISAV-B vaccine is designed to prevent infection from all known subtypes of the hepatitis B virus in adults. Side effects reported within seven days of vaccination include injection site pain, fatigue, and headache.
Dynavax is a commercial-stage biopharmaceutical company focused on developing vaccines against infectious diseases. In addition to HEPLISAV-B, the company has developed the CpG 1018® adjuvant used in multiple vaccines, including those for COVID-19.
This news is based on a press release statement by Dynavax Technologies.
InvestingPro Insights
As Dynavax Technologies Corporation (NASDAQ: DVAX) navigates the regulatory environment, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Dynavax holds a market capitalization of approximately $1.44 billion USD as of Q1 2024.
Despite a challenging revenue growth of -63.98% over the last twelve months as of Q1 2024, the company has managed to maintain a gross profit margin of 58.3%, demonstrating its ability to retain a significant portion of revenue after accounting for the cost of goods sold.
Investors should note that Dynavax is trading at a high earnings multiple, with a P/E ratio of 155.49 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at 172.65. This suggests that the market has high expectations for the company's future earnings potential. Moreover, with the stock trading near its 52-week low, some may view this as a potential buying opportunity, especially considering that Dynavax is expected to be profitable this year, as indicated by analyst predictions.
Two InvestingPro Tips that could be particularly relevant for Dynavax shareholders are that the company holds more cash than debt on its balance sheet and that it has liquid assets exceeding short-term obligations. These points highlight the company's solid financial positioning, which could provide resilience in the face of regulatory hurdles and market volatility. For those interested in more in-depth analysis, there are 9 additional InvestingPro Tips available for Dynavax, including insights on net income growth and stock price volatility, which can be found at https://www.investing.com/pro/DVAX.
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