Upcoming events – pivotal data loom for Novavax and Mallinckrodt

Welcome to your weekly digest of approaching regulatory and clinical readouts. Novavax is up 4% today thanks to topline results from a phase II trial showing that its Nanoflu influenza vaccine caused “vigorous immune responses” to four strains of flu, and that these responses were enhanced when the group’s Matrix-M adjuvant was added to the vaccine.

But an even more meaningful event is approaching. Novavax’s lead asset, a vaccine against respiratory syncytial virus, is in phase III, and after its disastrous failure two years ago in a study that was intended to be pivotal this is its last chance.

Resvax, also known as RSV F Vaccine since it targets the fusion protein of the virus, crashed out of the Resolve trial, testing it in prevention of moderate to severe RSV-associated lower respiratory tract disease, in mid-2016.