Novavax Inc. (NASDAQ: NVAX) was pummeled by shareholders on Friday after the company reported top-line results from its RSV F Vaccine trials. Essentially, the Resolve Phase 3 trial of RSV F Vaccine in 11,856 older adults (60 years of age and older), failed to meet the pre-specified primary or the secondary efficacy objectives and did not demonstrate vaccine efficacy.
RSV takes up a majority of the Novavax pipeline, with two of its indications in Phase 3. Novavax influenza treatment is the second closest to completion, with two of its vaccines in Phase 2. The remainder of the pipeline is still in Phase 1.
The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms.
The secondary objective of the trial was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD).
Gregory Glenn M.D., President, Research and Development, commented:
We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. 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. … We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults.
Apart from Friday’s implosion, Novavax had been more or less flat for the year thus far.
Shares of Novavax were last seen down about 85% at $1.27, with a consensus analyst price target of $14.11 and a 52-week trading range of $1.16 to $10.70.