EU and US could reach trade deal this weekend - Reuters
GAITHERSBURG, Md. - Novavax, Inc. (NASDAQ:NVAX), a profitable biotech company with a market capitalization of $1.17 billion and strong financial health according to InvestingPro metrics, announced Wednesday that its COVID-19-Influenza Combination (CIC) and standalone trivalent influenza vaccine candidates showed robust immune responses in the initial cohort of a Phase 3 trial.
Both vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid and Fluzone HD, respectively, according to the company. The vaccines prompted 2.4 to 5.7-fold increases in immune responses over baseline against the targeted strains.
The descriptive trial evaluated approximately 2,000 adults aged 65 and older. Nearly all solicited adverse events (over 98%) were mild or moderate in severity, with no new safety signals observed.
"Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated," said Ruxandra Draghia-Akli, Executive Vice President and Head of Research and Development at Novavax.
The trial was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 to inform a future registrational Phase 3 program. The company noted the trial was not adequately powered to demonstrate statistical significance.
Novavax stated it is pursuing partnering opportunities to advance further development of these programs. These results build on previous Phase 2 data for both vaccine candidates.
The information is based on a press release statement from Novavax.
In other recent news, Novavax Inc. has secured approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Nuvaxovid. This approval permits the vaccine’s use for adults aged 65 and older, as well as individuals aged 12 through 64 with certain high-risk health conditions. The FDA’s authorization has triggered a $175 million milestone payment from Sanofi, under a collaboration and license agreement. Novavax is preparing for the commercial delivery of its 2025-2026 COVID-19 vaccine formula in the U.S. this fall, pending further FDA recommendations.
In addition to the milestone payment, Novavax will receive ongoing tiered royalties from future vaccine sales. The FDA has also mandated a Phase 4 trial to further evaluate the vaccine’s efficacy and safety in a broader age group. JPMorgan analyst Eric Joseph has maintained an Underweight rating on Novavax stock, with a price target of $7.00, following this approval. Despite the positive development, Nuvaxovid sales are projected to be minimal in 2025, with a clearer market reception expected in the second half of 2026. Novavax’s partnership with Sanofi positions the company to expand its market reach, offering a non-mRNA vaccine option for high-risk populations.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.