Ladenburg Thalmann initiated coverage of Novavax (NASDAQ:NVAX) with a “buy” rating and $3 price target, as “we look for transformational data in the first quarter of 2019.” The stock closed at $2.27 on Dec. 17.
Novavax is developing ResVax, which could become the first vaccine against respiratory syncytial virus (RSV), a significant health concern for both infants and older adults.
Analyst Michael Higgins writes that the most advanced program is a maternal vaccination for neonatal protection, which is currently in the Phase 3 PREPARE trial. Vaccinations of adults aged over 60, and young children aged six months-to-five years old, have completed Phase 2 and 1 studies, respectively.
Novavax is also developing a potent non-egg-based flu vaccine, called NanoFlu, which “we believe could become the new standard of care,” he added. A Phase 1/2 study indicated superior performance against the H3N2 virus strain compared with Fluzone HD, the most potent FDA-approved flu vaccine, and a Phase 2 trial is now underway.
“We believe Novavax is approaching a major turning point with both pivotal RSV vaccine data and Phase 2 NanoFlu data expected in the first quarter of 2019,” Mr. Higgins said.
“Based on available data to date, including positive interim analysis from PREPARE, we believe both [vaccines] will be effective, leading to BLA filings and PDUFA [dates] for ResVax in the first quarter of 2020 and the third quarter of 2020, respectively, as well as [Novavax] advancing NanoFlu to a potential pivotal stage program in the second half of 2019,” he added.
