On Friday, H.C. Wainwright maintained a Buy rating and a $29.00 price target on shares of Dynavax (NASDAQ:DVAX) Technologies (NASDAQ:DVAX), following the company's recent announcement about the progression of its shingles vaccine candidate, Z-1018. Dynavax disclosed on Thursday that the first patient had been dosed in the Phase 1/2 study of Z-1018, which is being developed for the prevention of shingles in adults aged 50 and older.
The vaccine candidate combines glycoprotein E with the CpG 1018 adjuvant, and Dynavax believes it could potentially offer a better safety profile than the current market leader, Shingrix. The ongoing trial is a randomized, active-controlled, dose escalation, multi-center study that aims to evaluate the safety, tolerability, and immunogenicity of Z-1018 in comparison to Shingrix.
The trial's main goals are to determine the optimal dose level of glycoprotein E and to establish an appropriate dosing schedule for further clinical development. Additionally, the study will support the validation of a Patient Reported Outcome measurement tool, which Dynavax hopes will distinguish its vaccine in terms of tolerability and support potential label claims.
The study is targeting a total enrollment of approximately 440 healthy adults between the ages of 50 to 69, with trial sites located in Australia. Dynavax anticipates that topline immunogenicity and safety data from the trial will be available in the second half of 2025. The reaffirmed Buy rating and price target reflect the firm's confidence in the ongoing development of the vaccine candidate.
In other recent news, Dynavax Technologies has initiated a Phase 1/2 clinical trial for its investigational vaccine candidate, Z-1018, aimed at preventing shingles. The vaccine will be tested in approximately 440 healthy adults aged 50 to 69 years in Australia, with initial data expected in the second half of 2025.
Furthermore, Dynavax has reported year-over-year growth in its HEPLISAV-B net product revenue, despite a slight downturn in the U.S. hepatitis B vaccine market. The company projects the market opportunity for HEPLISAV-B to surpass $800 million by 2027.
On the regulatory front, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Dynavax's supplemental Biologics License Application (sBLA) for the use of Heplisav-B in adult patients undergoing hemodialysis treatment. In response, Goldman Sachs maintained a neutral rating for Dynavax, with a price target of $20.00. The company plans to request a meeting with the FDA to discuss additional data that could support approval for the four-dose regimen.
Other recent developments include progress in Dynavax's vaccine pipeline, such as promising results from its TdaP and plague vaccine programs.
InvestingPro Insights
As Dynavax Technologies (NASDAQ:DVAX) advances its shingles vaccine candidate, Z-1018, into clinical trials, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, Dynavax holds a solid financial position with more cash than debt on its balance sheet, providing a stable foundation for its research and development activities. Additionally, analysts are optimistic about the company's future, expecting net income to grow this year.
On the market side, Dynavax's current Market Cap stands at approximately $1.49 billion, reflecting investor confidence in the company's potential. While it trades at a high earnings multiple, with a P/E Ratio (Adjusted) for the last twelve months as of Q1 2024 sitting at 177.98, this can be indicative of high growth expectations from the market. Moreover, with a Price to Book ratio of 2.41, the company appears to be valued reasonably in relation to its assets.
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