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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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ROSEN, TOP RANKED GLOBAL COUNSEL, Encourages Five9, Inc. Investors to Secure Counsel Before Important February 3 Deadline in Securities Class Action – FIVN

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New York, New York–(Newsfile Corp. – January 26, 2025) – WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities, including call options, of Five9, Inc. (NASDAQ: NASDAQ:) between June 4, 2024 and August 8, 2024, both dates inclusive (the “Class Period”), of the important February 3, 2025 lead plaintiff deadline.

SO WHAT: If you purchased Five9 securities or call options during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Five9 class action, go to https://rosenlegal.com/submit-form/?case_id=32046 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email case@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than February 3, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action (WA:) Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) Five9’s net new business was not “strong irrespective of the macro” and was, in fact, hampered by macroeconomic issues such as constrained and scrutinized customer budgets; (2) Five9 was in the midst of a challenging bookings quarter due, in part, to sales execution and efficiency issues, and Five9 was not “seeing very strong bookings momentum”; and (3) defendants did not have “enough information in terms of [their] existing customers that are going live” such that the statements that Five9 would see a positive inflection in its dollar-based retention rate lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Five9 class action, go to https://rosenlegal.com/submit-form/?case_id=32046 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email case@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook (NASDAQ:): https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/238378

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Head of disaster relief agency FEMA reassures staff after Trump criticism

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(Reuters) – The acting head of the Federal Emergency Management Agency wrote to staff reassuring them that the agency’s continued existence was vital to the country’s disaster response efforts, after President Donald Trump said he wanted to overhaul or scrap it.

“FEMA is a critical agency which performs an essential mission in support of our national security,” said Cam Hamilton, a former Navy SEAL, who was appointed by Trump to temporarily lead the agency after the Republican president took office last week.

Hamilton sent the email to all staff on Friday night after earlier in the day Trump, during a visit to disaster areas in North Carolina and California, vowed to sign an executive order to overhaul or eliminate the main federal agency that responds to natural disasters.

“FEMA has turned out to be a disaster,” Trump said during a tour of a North Carolina neighborhood destroyed by September’s Hurricane Helene. “I think we recommend that FEMA go away.”

Trump accused FEMA of bungling emergency relief efforts there and said he preferred that states be given federal money to handle disasters themselves.

“President Trump has laid out his intent to reform FEMA, and we stand firmly at the ready to implement real and lasting reform,” Hamilton wrote in the email seen by Reuters. “We have some work to do at FEMA and restoring public confidence in this agency is essential.”

FEMA did not immediately respond to a request for comment on Hamilton’s email.

© Reuters. FILE PHOTO: Swannanoa resident Lucy Bickers, who received assistance from FEMA after Hurricane Helene damaged her property, holds a sign in support of the government agency as she waits on the route of visiting U.S. President Donald Trump's motorcade in Swannanoa, North Carolina, U.S., January 24, 2025/File Photo

FEMA brings in emergency personnel, supplies and equipment to help areas begin to recover from natural disasters. Funding for the agency has soared in recent years as extreme weather events have increased the demand for its services.

The agency has 10 regional offices and employs more than 20,000 people across the country.

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Colombia turns away two US military flights with deported migrants, official says

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By Phil Stewart and Oliver Griffin

WASHINGTON/BOGOTA (Reuters) -Colombia on Sunday turned away two U.S. military aircraft with migrants being deported as part of President Donald Trump’s immigration crackdown, a U.S. official said, in at least the second case of a Latin American nation refusing U.S. military deportation flights.

Colombian President Gustavo Petro condemned the practice, suggesting it treated migrants like criminals. In a post on social media platform X, Petro said Colombia would welcome home deported migrants on civilian planes, saying they should be treated with dignity and respect.

Colombia’s decision follows one by Mexico, which also refused a request last week to let a U.S. military aircraft land with migrants.

“The U.S. cannot treat Colombian migrants as criminals,” Petro wrote, noting that there were 15,660 Americans without proper immigration status in Colombia.

Petro’s comments add to the growing chorus of discontent in Latin America as Trump’s week-old administration starts mobilizing for mass deportations.

Brazil’s foreign ministry late on Saturday condemned “degrading treatment” of Brazilians after migrants were handcuffed on a commercial deportation flight. Upon arrival, some of the passengers also reported mistreatment during the flight, according to local news reports.

The plane, which was carrying 88 Brazilian passengers, 16 U.S. security agents, and eight crew members, had been originally scheduled to arrive in Belo Horizonte in the southeastern state of Minas Gerais.

There, Brazilian officials ordered the removal of the handcuffs, and President Luiz Inácio Lula da Silva designated a Brazilian Air Force (FAB) flight to complete their journey, the government said in a statement Saturday.

The commercial charter flight was the second this year from the U.S. carrying undocumented migrants deported back to Brazil and the first since Trump’s inauguration, according to Brazil’s federal police.

Officials from the U.S. State Department, Pentagon, U.S. Department of Homeland Security and U.S. Immigration and Customs Enforcement did not immediately reply to requests for comment.

The use of U.S. military aircraft to carry out deportation flights is part of the Pentagon’s response to Trump’s national emergency declaration on immigration on Monday.

In the past, U.S. military aircraft have been used to relocate individuals from one country to another, like during the U.S. withdrawal from Afghanistan in 2021.

© Reuters. Ciudad Juarez, Mexico December 19, 2024. REUTERS/Jose Luis Gonzalez

This has been the first time in recent memory that U.S. military aircraft were used to fly migrants out of the country, one U.S. official said.

U.S. military aircraft carried out two similar flights, each with about 80 migrants, to Guatemala on Friday.

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