On Thursday, shares of Novavax Inc. NVAX , a specialty biopharmaceutical company, are down on after-hours trading, plunging almost 83% on news that topline data from its Resolve ™ Phase 3 trial did not meet pre-specified primary or secondary efficacy objectives.
The Phase 3 trial of the company's RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine), a prevention treatment for the flu, was administered to 11,856 older adults (60+).
The trial was randomized, observer-blinded, placebo-controlled, and conducted at 60 different sites across the U.S. The primary objective was to show the efficacy of preventing moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), while the secondary objective was to show efficacy in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD).
"We are both surprised and disappointed by the outcome of the Resolve ™ trial, which we recently un-blinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results," said Gregory Glenn M.D., President, Research and Development.
Novavax reported that the attack rate for the Resolve Phase 3 trial primary objective was roughly 25% of that observed in the Phase 2 trial. The company also reported that topline data from its Phase 2 rollover trial suggest that improved vaccine efficacy will come from a second year of dosing.
NVAX is currently a #4 (Sell) on the Zacks Rank, and is down 14.77% over the past twelve months.
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