GAITHERSBURG, Md., May 1, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced it will report its first quarter 2025 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Thursday, May 8, 2025. Details of the event and replay are as follows: Conference call details: Date: May 8, 2025 Time: 8:30 a.m. U.S. ET URL to register phone: https://emportal.ink/43UHjFq Dial-in number: (800) 836-8184 (Domestic) or (+1) (646) 357-8785 (International) Webcas ...

TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses CHATHAM, N.J., April 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding C ...

CHATHAM, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Company will deliver an oral presentation and lead a panel discussion at the World Vaccine Congress Washington 2025, which will be held in Washington, D.C., April 22-24, 2025. A copy of the Company's presentation will be available under the Scientific P ...

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]

Vaxcyte (PCVX) is a clinical-stage biotech focused on developing vaccines to prevent or treat bacterial infectious diseases.In the past month, PCVX's shares have nosedived 56%. This downside came after Vaxcyte reported mixed results from a phase II study on its investigational pneumococcal conjugate vaccine (PCV) in healthy infants.Adding to this headwind, the broader biotech/drug sector is feeling the pressure from the resignation of a senior FDA official instrumental in driving biotech innovation, which h ...

Shares of Valneva (VALN) rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.The safety of the vaccine wil ...

Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2024 Earnings Conference Call February 20, 2025 4:30 PM ET Company Participants Paul Cox - Vice President, Investor Relations & Corporate Communications Ryan Spencer - Chief Executive Officer Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - Chief Financial Officer Conference Call Participants Matt Phipps - William Blair Roy Buchanan - Citizens Jonathan Miller - Evercore ISI Phil Nadeau - TD Cowen Ed White - H.C. Wa ...