CEO Stanley C. Erck said, “The successful Phase 2 results for our NanoFlu vaccine provide an opportunity to now confirm with the FDA the use of accelerated approval for licensure. We are now prepared to make meaningful advances on these programs during 2019.”
Research and development expenses decreased by 13% to $43.4 million in Q4, primarily due to decreased development activities of ResVax and lower employee-related costs.
The Q4 earnings come at a crucial point of time for Novavax when it is trading near an all-time low, hammered by a clinical trial failure late last month.
The stock tumbled 65%, wiping off around $500 million of its market value after it emerged that its respiratory disorder vaccine failed to meet the primary end-point in the late-stage clinical study.
READ: TREVENA SLIPS ON WIDER-THAN-EXPECTED Q4 LOSS
ResVax, which is aimed at preventing the action respiratory syncytial virus (RSV) among infants, meanwhile, did show some positive results towards its secondary endpoint of preventing hospitalization.
The Rockville, Maryland-based company had said it would discuss the results with the regulatory authorities in the US and Europe for the future course of action.
NVAX shares have slumped over 75% in the trailing 52 weeks, far worse than the industry.