Latest news with #COVID-influenza
The Hindu
3 days ago
- Business
- The Hindu
Novavax's COVID-flu combo vaccine shows strong immune response in trial
Novavax's experimental COVID-19-influenza combination and standalone influenza vaccines generated a strong immune response in adults aged 65 and older, similar to already approved shots against the viruses in a late-stage trial. Both the vaccine candidates were well tolerated with no new safety concerns, the biotech said on 11 June 2025. . Its shares rose 1.3% to $7.29 in premarket trading. The study, which involved about 2,000 participants, tested the safety and immune response of the COVID-influenza combination and standalone flu vaccines compared to its COVID-19 shot Nuvaxovid and Sanofi's flu shot Fluzone HD, respectively. Novavax said the study was not designed to show statistically significant results. The data will be used to design a future late-stage study, which can be submitted for regulatory approval, it said. The Maryland-based biotech, which is shifting its focus to commercialising its candidates through partnerships, said it continues to look for partners that can advance further development of these experimental vaccines. It had signed a licensing deal with Sanofi worth up to $1.2 billion last year to commercialize and further develop its COVID-19 vaccine, Nuvaxovid. Nuvaxovid gained the U.S. approval last month after the Food and Drug Administration missed an April 1 target to approve the shot. The approval, however, limited its use to older adults and at-risk individuals over the age of 12. The traditional protein-based shot offers an alternative to its messenger RNA-based rivals from Pfizer/BioNTech and Moderna. Earlier this week, health secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, fired all members of a U.S. Centers for Disease Control and Prevention panel of vaccine experts — a move public health experts said could undermine confidence in currently available shots.
Yahoo
09-05-2025
- Business
- Yahoo
Novavax Inc (NVAX) Q1 2025 Earnings Call Highlights: Revenue Surge Amid Strategic Partnerships ...
Release Date: May 08, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novavax Inc (NASDAQ:NVAX) reported a significant increase in total revenue for Q1 2025, reaching $667 million compared to $94 million in Q1 2024. The company has successfully closed out agreements with Canada and New Zealand, recognizing $603 million in revenue from these terminations. Novavax Inc (NASDAQ:NVAX) is actively pursuing new partnerships and collaborations, including an expanded agreement with Takeda for the Japanese market. The company is focused on optimizing its partnership with Sanofi, which includes potential milestones and royalties from new combination vaccines. Novavax Inc (NASDAQ:NVAX) is advancing its early-stage pipeline with four new programs and leveraging artificial intelligence and machine learning for R&D. The company is still awaiting FDA approval for its COVID-19 vaccine BLA, with ongoing discussions about postmarketing commitments. Novavax Inc (NASDAQ:NVAX) has not yet secured a partner for the development and commercialization of its latest COVID-influenza combination vaccine. The company's revenue framework for 2025 excludes potential additional revenue from Sanofi supply sales and other milestones, indicating uncertainty in future earnings. There is a reliance on milestone payments and royalties from partners like Sanofi and Takeda, which may impact financial stability if not realized. Novavax Inc (NASDAQ:NVAX) is undergoing significant cost reductions and restructuring, which may affect its operational capabilities in the short term. Warning! GuruFocus has detected 3 Warning Signs with NVAX. Q: Can you comment on the nature of the FDA's postmarketing commitment request and its potential impact on the 2025-2026 season? A: We haven't publicly detailed the nature of the postmarketing commitment. However, we are working diligently with the FDA to reach a positive conclusion. We do not foresee a direct impact on the 2025-2026 season discussions by the Vaccines and Related Biological Products Advisory Committee (VRBPAC). - John Jacobs, President and CEO Q: What is the target profile for the mid-year data readout of your flu program to attract partnerships? A: The current study is not an efficacy trial but aims to generate additional immunogenicity and safety data to inform the design of a future phase 3 trial. Our intention is to partner both our late-stage COVID-19 and flu assets. - Dr. Alexandra Draghia, Head of R&D Q: How does the SHIELDUA study impact regulatory perspectives on adjuvanted protein-based vaccines versus mRNA vaccines? A: The SHIELDUA study is observational and informs consumers more than regulators. Regulators focus on the safety and efficacy of vaccines on their own merits. The study is part of real-world evidence that looks at various vaccine characteristics post-introduction. - Dr. Alexandra Draghia, Head of R&D Q: Regarding the APA revenues recognized this quarter, how much is cash today versus future cash? A: The $603 million from Canada and New Zealand is non-cash revenue. We received this cash in prior years, and the agreements' termination allows us to retain it. - Jim Kelly, Chief Financial Officer Q: Is the post-marketing clinical trial requirement specific to Novavax's BLA filing, or will it apply to all COVID-19 vaccines? A: We cannot speculate on FDA's requirements for other companies. Our discussions with the FDA are specific to our filing. - John Jacobs, President and CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
