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Novavax Stock Plunges After Respiratory Disease Vaccine Fails in Trial
Novavax Stock Plunges After Respiratory Disease Vaccine Fails in TrialNovavax said on Thursday that its experimental vaccine for a serious infectious respiratory disease failed at the final stage of human testing, sending its stock plunging more than 80%.The drug failed to meet the main or secondary efficacy goals of a Phase III trial of nearly 12,000 older adults, the company said in a news release.The trial was intended to show that the Novavax vaccine could prevent moderate to severe respiratory syncytial virus, commonly known as RSV.
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Vical-Astellas CMV Vaccine Candidate Fails Phase II Study
Vical-Astellas CMV Vaccine Candidate Fails Phase II StudyVical and Astellas Pharma said today that their ASP0113 failed a Phase II trial comparing the cytomegalovirus (CMV) vaccine candidate to placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor.ASP0113 did not meet the study's primary endpoint—the proportion of patients having CMV viremia, defined as a plasma viral load of ≥1000 IU/mL by central laboratory assay through 1 year after first injection of the vaccine.The trial's secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy were similar in both treatment groups, on the basis of an evaluation by an independent, blinded Adjudication Committee.
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Novavax RSV F Vaccine Fails Phase III Trial
Novavax RSV F Vaccine Fails Phase III TrialNovavax acknowledged that its respiratory syncytial virus (RSV) F-protein recombinant nanoparticle vaccine candidate failed a Phase III trial, sending the company's shares crashing by more than three-quarters in after-hours trading.RSV F Vaccine missed its primary and secondary efficacy endpoints in the Phase III Resolve trial, in which the vaccine was given to 11,856 adults aged 60 and older.The trial's primary objective was to show the RSV F Vaccine's efficacy in preventing moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), defined by the presence of multiple lower respiratory tract symptoms.
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