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FDA issues response to Dynavax’s HEPLISAV-B sBLA

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EMERYVILLE, Calif. – Dynavax (NASDAQ:) 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.

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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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For readers looking to explore these insights further, InvestingPro offers a range of tools and data to help make informed investment decisions. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Insperity appoints new independent director

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HOUSTON – Insperity, Inc. (NYSE: NYSE:), a provider of HR and business performance solutions, has announced the appointment of Phil Wilmington as a new independent director to its board. Wilmington, who recently retired as Vice Chairman of Workday (NASDAQ:), Inc., brings a wealth of experience from the HR services and software sectors to the role.

Wilmington’s appointment as a Class I director includes his service on the Compensation Committee, with a term set to expire at the annual stockholders meeting in 2026. His career has spanned executive leadership positions at PeopleSoft, CEO of OutlookSoft, and President and COO of Tidemark Systems, Inc., contributing to his reputation for fostering growth and innovation in the industry.

“I am honored to serve in this important role and bring additional insights and guidance based on my experience at Workday and other high-growth companies,” said Wilmington. “I look forward to working with my new board colleagues to bring continued growth and success to the businesses Insperity serves.”

Paul J. Sarvadi, chairman and CEO of Insperity, expressed confidence that Wilmington’s expertise, particularly his strategic partnership experience with Workday, will provide invaluable insight to advance Insperity’s mission of serving America’s small and medium-sized businesses.

Insperity, established in 1986, has been committed to helping businesses succeed, which in turn contributes to community prosperity. The company offers a comprehensive suite of HR solutions and has reported 2023 revenues of $6.5 billion. With over 90 locations across the United States, Insperity continues to impact numerous businesses and communities.

This expansion of the board reflects Insperity’s ongoing strategy for growth through innovation and superior offerings. The information regarding Wilmington’s appointment is based on a press release statement from Insperity, Inc.

InvestingPro Insights

As Insperity, Inc. (NYSE: NSP) welcomes Phil Wilmington to its board, the company’s financial health and market performance remain a key interest for investors. With a market cap of approximately $3.88 billion USD, Insperity stands as a significant player in the HR and business performance solutions sector.

The company’s commitment to innovation and growth is further underscored by its strong financial position, as highlighted by an InvestingPro Tip that notes Insperity holds more cash than debt on its balance sheet, providing a solid foundation for strategic initiatives and potential market maneuvers.

Another noteworthy InvestingPro Tip is Insperity’s track record of maintaining dividend payments for 20 consecutive years, which could be particularly appealing to income-focused investors. This consistency in rewarding shareholders is complemented by a dividend yield of 2.21% as of the latest data, and a notable dividend growth of 9.62% over the last twelve months as of Q1 2024.

While Insperity’s Price / Book multiple stands at a high 27.71, reflecting a premium valuation, this could be indicative of the market’s confidence in the company’s assets and future prospects. Moreover, analysts predict profitability for the current year, aligning with the company’s profitable performance over the last twelve months. With these insights, investors can gauge the company’s value proposition in the context of its industry and historical performance.

For those interested in a deeper dive into Insperity’s financial metrics and additional strategic tips, there are more InvestingPro Tips available at https://www.investing.com/pro/NSP. To enhance your investing strategy, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro, where you can find a total of 5 additional tips to inform your investment decisions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Bankwell Financial EVP sells shares worth over $48k

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Bankwell Financial Group, Inc. (NASDAQ:) Executive Vice President and Chief Risk & Operations Officer, Steven H. Brunner, has sold a total of 2,005 shares of the company’s common stock in a series of transactions dated May 17 and May 21, 2024, totaling over $48,366. The shares were sold at prices ranging from $24.07 to $24.15 each.

The sale was reported in a recent filing with the Securities and Exchange Commission. Following the transactions, Brunner’s direct holdings in Bankwell Financial Group have adjusted to reflect the recent sales, yet he continues to hold a significant number of shares in the company, indicating continued alignment with the company’s performance.

The transactions occurred at a time when Bankwell Financial Group’s stock has been under the scrutiny of investors, with the financial sector experiencing various market pressures. The exact reasons for Brunner’s sale have not been disclosed, but such sales are not uncommon and can occur for a variety of personal or financial planning reasons.

Bankwell Financial Group, headquartered in New Canaan, Connecticut, operates as the bank holding company for Bankwell Bank, providing a range of banking services to the local community. The company has a strong presence in the region and has been part of the financial landscape for many years.

Investors often monitor insider transactions as they provide insights into how executives and directors are positioning themselves with respect to their company’s stock. While these sales represent a decrease in Brunner’s direct ownership, it’s important to note that executives may sell shares for reasons unrelated to their outlook on the company such as diversifying their investment portfolio or other personal financial considerations.

Shareholders and potential investors in Bankwell Financial Group are advised to consider the context of such transactions and to review the company’s ongoing performance and future prospects as part of their investment decision-making process.

InvestingPro Insights

Amidst the recent insider transactions at Bankwell Financial Group, Inc. (NASDAQ:BWFG), it’s valuable for investors to consider the company’s financial health and market performance. Bankwell Financial Group is currently trading at a low earnings multiple, with a P/E ratio of 6.37, reflecting a market sentiment that may see the stock as undervalued. This could be an opportune time for value investors to take a closer look, especially considering the company’s track record of maintaining dividend payments for 10 consecutive years, boasting a current dividend yield of 3.28%.

Despite a challenging environment marked by a revenue decline of 7.9% over the last twelve months as of Q1 2024, Bankwell Financial Group has managed to maintain a strong operating income margin of 48.14%. This is a testament to the company’s operational efficiency and could be a reassuring factor for investors concerned about the recent insider selling.

InvestingPro Tips reveal that while Bankwell Financial Group suffers from weak gross profit margins and is expecting a net income drop this year, analysts predict the company will be profitable this year, and it has been profitable over the last twelve months. For investors seeking more in-depth analysis, there are additional InvestingPro Tips available, which can be accessed by visiting InvestingPro. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and discover the full range of expert insights and tips to guide your investment decisions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Cancellation of Repurchased Shares Representing 4.7% of the Capital of Teleperformance

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Share capital reduction by way of cancellation of treasury shares

PARIS–(BUSINESS WIRE)–Regulatory News:

The Board of Directors of Teleperformance SE (Paris:TEP), which met today, decided to cancel 3,000,000 treasury shares, representing 4.7% of the share capital, pursuant to the authorization granted by the combined shareholders’ meeting of April 13, 2023, under its 19th resolution.

Following this cancellation, Teleperformance SE directly holds 880 891 of its own shares, i.e. 1.5% of its share capital. The share capital now amounts to 51,107,635 euros divided into 60,443,054 shares carrying 61,942,589 gross voting rights.

The 3,000,000 shares cancelled were repurchased on the market as part of the share buyback program implemented on April 13, 2023 following a decision of the Board on the same day, the description of said program is available online on the website www.teleperformance.com

Daniel Julien, Chairman and co-CEO of Teleperformance, commented: The shares repurchase and their cancellation arose from the stock price which does not reflect properly the Group’s strong cash flow generation, its unrivaled, industry-leading performance in a challenging macroeconomic environment, and its future growth prospects.

About Teleperformance Group

Teleperformance (TEP “ ISIN: FR0000051807 “ Reuters: TEPRF.PA – Bloomberg: TEP FP), is a global leader in digital business services which consistently seeks to blend the best of advanced technology with human empathy to deliver enhanced customer care that is simpler, faster, and safer for the world’s biggest brands and their customers. The Group’s comprehensive, AI-powered service portfolio ranges from front-office customer care to back-office functions, including operations consulting and high-value digital transformation services. It also offers a range of specialized services such as collections, interpreting and localization, visa and consular services, and recruitment process outsourcing services. The teams of multilingual, inspired, and passionate experts and advisors, spread in close to 100 countries, as well as the Group’s local presence allows it to be a force of good in supporting communities, clients, and the environment. In 2023, Teleperformance reported consolidated revenue of €8,345 million (US$9 billion) and net profit of €602 million.

Teleperformance shares are traded on the Euronext Paris market, Compartment A, and are eligible for the deferred settlement service. They are included in the following indices: , , S&P Europe 350, MSCI Global Standard and Euronext Tech Leaders. In the area of corporate social responsibility, Teleperformance shares are included in the CAC 40 ESG since September 2022, the Euronext Vigeo Euro 120 index since 2015, the MSCI Europe ESG Leaders index since 2019, the FTSE4Good index since 2018 and the S&P Global 1200 ESG index since 2017.

For more information: www.teleperformance.com Follow us on X (Twitter): @teleperformance

FINANCIAL ANALYSTS AND INVESTORS
Investor relations and financial communications department
TELEPERFORMANCE
Tel: +33 1 53 83 59 15
investor@teleperformance.com

PRESS RELATIONS
Europe
Karine Allouis “ Laurent Poinsot
IMAGE7
Tel: +33 1 53 70 74 70
teleperformance@image7.fr

PRESS RELATIONS
Americas and Asia-Pacific
Nicole Miller
TELEPERFORMANCE
Tel: + 1 629-899-0675
nicole.miller@teleperformance.com

Source: Teleperformance

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