Novavax Phase 3 ResVax trial misses primary endpoint
Novavax (NASDAQ:NVAX) reported that its Phase 3 PREPARE studyfor ResVax, a RSV (respiratory syncytial virus) F vaccine, did not meet its primary objective of preventing medically significant RSV lower respiratory tract infection (LRTI).
The study enrolled 4,636 third trimester pregnant women, with 3,000 receiving ResVax. While the trial did not meet its primary endpoint, it did show efficacy against its secondary objective, RSV LRTI-related hospitalization. Novavax plans to meet with U.S. and European regulators to review the data and discuss potential approval pathways.
In a new report, Ladenburg Thalmann analyst Michael Higgins reiterated his “buy” recommendation for Novavax but lowered his price target to $2 from $3.50. The stock tumbled $1.42 to 70 cents on Feb. 28.
Mr. Higgins said that while the trial did not meet its primary endpoint, it showed efficacy against the most severe symptoms of RSV and reduced RSV hospitalization. In addition, ResVax was safe, which “we believe will be important for future regulatory discussions,” he added.
“Following PREPARE’s failed outcome, Novavax’s novel flu vaccine, NanoFlu, should get some overdue attention,” Mr. Higgins said.
In January, Novavax reported that in a Phase 2 trial with older adults, NanoFlu, a non-egg-based recombinant nanoparticle flu vaccine, showed superiority against the most potent approved flu vaccine, Fluzone HD, in several of the deadliest flu strains, including several drifted strains.
Novavax plans to meet with the FDA in the first half of 2019 to discuss the Phase 2 results and plans for a Phase 3 program for NanoFlu, which could be completed in the first half of 2020, Mr. Higgins added.