Conference call to begin at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today announced it will provide a business update and report financial results for the first quarter ended March 31, 2025, after the market close on Tuesday, May 13, 2025. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET. The conference call can be accessed using the following information: Webcast: Click hereDate: Tuesday, ...

COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognize ...

Core Viewpoint - 康希诺 has shown significant improvement in its financial performance, with a notable reduction in losses and a positive revenue growth trajectory, indicating a potential recovery from the impacts of the COVID-19 pandemic [2][3][4]. Financial Performance - In Q1 2025, 康希诺 reported revenue of 1.074 billion yuan, a year-on-year increase of 20.02%, while the net loss attributable to shareholders was 11.55 million yuan, down from a loss of 170 million yuan in the same period last year [2]. - The company achieved a substantial reduction in losses due to several factors, including the absence of one-time special losses from the previous year, increased market share of its meningococcal products, and additional government subsidies [2][4]. - For the full year 2024, 康希诺's revenue grew by 137.01% to 846 million yuan, with a narrowed net loss of 379 million yuan [3]. Market Position and Competitiveness - 康希诺's performance stands out in a challenging vaccine market, where most domestic vaccine manufacturers reported declines in revenue [4][3]. - The company’s meningococcal vaccine, 曼海欣, has become a key revenue driver, contributing significantly to its Q1 2025 revenue [7][10]. - Despite the overall decline in the meningococcal vaccine market, 康希诺's products have shown growth, with 曼海欣's approval and sales expected to continue expanding [9][10]. Product Pipeline and Future Prospects - 康希诺 has two approved meningococcal vaccines, with 曼海欣 being the primary revenue contributor, and is actively pursuing market expansion both domestically and internationally [6][10]. - The company is also awaiting approval for its 13-valent pneumococcal conjugate vaccine, which could further enhance its product portfolio, although competition in this segment is strong [11]. - The future growth potential of 康希诺 remains uncertain, as its current and upcoming products may not provide significant long-term growth opportunities [11].

- Topline data expected in mid-2025 - SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine, where there is a significant unmet need,” said Steven Lo, Chief Executive Officer ...

Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]

Urges Stockholders to Vote "FOR" All Four Dynavax Director Nominees on the GOLD Proxy Card Highlights Record Financial and Operational Results, Balanced Capital Allocation Strategy andMeaningful Board Refreshment Underscores Deep Track's Value Destructive, Short-Term Focus and Unnecessary Proxy Contest EMERYVILLE, Calif., April 17, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing inn ...

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]

Core Insights - Valneva SE and LimmaTech Biologics AG have initiated a Phase 2 infant safety and immunogenicity study for Shigella4V2 (S4V2), a tetravalent bioconjugate vaccine candidate against shigellosis, marking a significant step in vaccine development [1][3][4] Industry Overview - Shigellosis is the second leading cause of fatal diarrheal disease globally, with an estimated 165 million infections annually, of which 62.3 million occur in children under five years [2][6] - The disease results in approximately 600,000 deaths each year, highlighting the urgent need for an effective vaccine [6] Study Details - The Phase 2 study (Identifier: NCT06523231) will involve around 110 nine-month-old infants to determine the optimal vaccine dosage for future Phase 3 trials [3] - The study is randomized, controlled, and blinded, taking place at a single site in Kenya, with results expected in the second half of 2025 [3] Company Statements - Dr. Juan Carlos, Chief Medical Officer of Valneva, emphasized the unacceptable mortality rates from shigellosis and the company's commitment to developing vaccines for unmet medical needs [4] - Dr. Patricia Martin, COO of LimmaTech, highlighted the trial's initiation as a significant milestone in their collaboration with Valneva to address this global health threat [4] Regulatory Status - The U.S. FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious health condition and fill an unmet medical need [5]

Core Insights - Vaxcyte, Inc. announced positive topline results from its Phase 2 dose-finding study for VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate, demonstrating safety and immunogenicity comparable to Prevnar 20® (PCV20) in healthy infants [2][3][4] Group 1: VAX-24 Study Results - VAX-24 was well-tolerated across all evaluated doses, with a safety profile similar to PCV20, and no serious adverse events related to the vaccine were reported [3][4] - Substantial immune responses were elicited post-primary three-dose immunization series, with robust IgG and opsonophagocytic assay (OPA) responses observed across all doses [4][5] - The mid dose of VAX-24 (2.2 mcg) was selected for further development based on its ability to meet non-inferiority criteria and generate robust immune responses [5][6] Group 2: Future Development Plans - The company plans to advance VAX-24 to a potential Phase 3 program, pending topline data from the VAX-31 Phase 2 study expected in mid-2026 [2][6] - Vaxcyte is also introducing VAX-XL, a third-generation PCV candidate aimed at expanding the spectrum of coverage against pneumococcal disease [2][6] - Key milestones include the initiation of a Phase 3 infant program with either VAX-24 or VAX-31 and the announcement of additional data from ongoing studies [8][10][11] Group 3: Study Design and Participant Information - The VAX-24 Phase 2 study is a randomized, observer-blind, dose-finding study involving 802 healthy infants, assessing safety, tolerability, and immunogenicity [7][9] - The study design includes a primary immunization series of three doses followed by a booster dose, with ongoing evaluations of immunogenicity and safety [9][10] Group 4: Industry Context - Pneumococcal disease remains a significant health threat, particularly in children under five, with Streptococcus pneumoniae being a leading cause of vaccine-preventable deaths globally [14][15] - The development of broader-spectrum vaccines like VAX-24 and VAX-31 is critical to addressing the substantial burden of invasive pneumococcal disease [6][14]

Core Viewpoint - Valneva SE is responding to a chikungunya outbreak in La Réunion by providing 40,000 doses of its vaccine IXCHIQ, with a focus on vaccinating vulnerable populations, particularly adults aged 65 and over with co-morbidities [1][2][4]. Group 1: Company Actions and Vaccine Details - Valneva will supply 40,000 doses of IXCHIQ starting in early April, with the option to provide more doses as needed [1]. - IXCHIQ is the world's first licensed chikungunya vaccine, approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5]. - The company is focused on expanding access to IXCHIQ, including a partnership with CEPI that received a $41.3 million grant to enhance vaccine access in Low- and Middle-Income Countries (LMICs) [5][6]. Group 2: Public Health Context and Response - Chikungunya cases in La Réunion have surged, with 8,600 cases reported and nearly 3,000 new cases in the week of March 3 to 9, 2025, prompting local authorities to implement a Level 4 emergency crisis management plan [2]. - The Haute Autorité de Santé recommended prioritizing vaccination for adults aged 65 and over, especially those with co-morbidities, followed by adults aged 18 and over with co-morbidities [4]. - The CDC has issued a travel alert due to the outbreak, highlighting the potential for transmission to mainland France and other territories [2]. Group 3: Broader Implications and Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ in Asia, ensuring affordable access to public health markets in LMICs [6][7]. - The company previously established a partnership with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for Latin American countries [7]. - The World Health Organization has identified chikungunya as a significant public health issue, with the disease affecting over 110 countries and the economic impact expected to grow due to climate change [9].