Key Takeaways Moderna gained full FDA approval for Spikevax in high-risk children aged six months to 11 years. The vaccine was previously available for this group only under Emergency Use Authorization. Updated Spikevax will be available for eligible patients in the 2025-2026 U.S. vaccination season.Moderna (MRNA) announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 vaccine, Spikevax, for use in children aged six months to 11 years, who are at in ...

Cidara Therapeutics, Inc. CDTX stock is trading over 90% higher on Monday with a session volume of 3.2 million compared to the average volume of 181.7K.On Monday, the company released topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64.The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) for each of three dose groups in in ...

Key Takeaways Novavax reported strong immune responses from its COVID-19-influenza combo in adults 65 and older. The study guides the design for another late-stage trial that could support regulatory submissions. Novavax seeks partnerships to fund the development and commercialization of both vaccine candidates.Novavax (NVAX) announced encouraging results from an initial cohort of a late-stage study evaluating its experimental COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidat ...

Novavax, Inc. (NASDAQ:NVAX) Goldman Sachs 46th Annual Global Healthcare Conference June 11, 2025 2:00 PM ET Company Participants James Patrick Kelly - Executive VP, CFO & Treasurer John Charles Jacobs - President, CEO & Director Ruxandra Draghia-Akli - EVP and Head of Research & Development John Charles Jacobs Are we ready to go? Are we live? Hello, everyone. Hi, I'm John Jacobs, CEO of Novavax, and I'm joined here today by Jim Kelly, our CFO; and Dr. Ruxandra Draghia, who heads up our R&D. I want to thank ...

Both vaccine candidates induced robust immune responses across all antigens tested No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanopa ...

Key Takeaways Moderna received FDA approval for mNexspike, its next-gen COVID-19 vaccine with limited use criteria. Vaccine is cleared for older adults and high-risk individuals aged 12-64, not the broader group MRNA wanted. The vaccine offers a better shelf life and matched or outperformed Spikevax in late-stage trial data.Moderna (MRNA) announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will ...

Moderna (MRNA) announced that it has submitted a regulatory filing with the FDA seeking approval for an updated version of its COVID-19 vaccine Spikevax, designed to target the LP.8.1 variant of the virus.The submission is based on guidance from the FDA issued last week, which advised vaccine-makers to update their COVID-19 shots to target strains that are part of the JN.1 lineage, with a preference for the LP.8.1 variant. Per the latest CDC data, LP.8.1 currently accounts for about 70% of total cases in th ...

Thank you for reading my research on Seeking Alpha. If you want to learn even more about my method and how I discover these investment opportunities, please check out my subscription marketplace service, Compounding Healthcare , and sign up for a free trial.After years of strategic pivots and battling the bureaucracy, Novavax (NASDAQ: NVAX ) has finally secured full FDA approval of their COVID-19 vaccine, NUVAXOVID. Not only does the BLA approval validate Novavax’s recombinant protein-based vaccine technolo ...

A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service Organization starts with the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.Novavax can finally breathe a sigh of relief – at least a small one.The Food and Drug Administration approved the company's Covid-19 vaccine a ...

Shares of Novavax (NVAX) surged nearly 26% in pre-market trading today after its protein-based COVID-19 vaccine, Nuvaxovid, received the long-awaited approval from the FDA, albeit with a narrower label than initially expected.FDA’s Conditions on NVAX’s COVID-19 JabWhile the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine’s use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from CO ...