Novavax’s Phase III RSV Vaccine Failure Wipes Out Nearly $2bn In Value

Novavax shocked investors with negative results for its RSV vaccine in a Phase III clinical trial immunizing older adults, but promised more data – and ideas for a potential second Phase III trial – in October.

Novavax Inc.’s closely watched respiratory syncytial virus (RSV) vaccine – widely expected to show positive Phase III results after a successful Phase II program – not only fell short in its first Phase III clinical trial, but it was less effective than placebo in preventing moderate-to-severe RSV in older adults.

“It’s clear that there will not be a [biologic license application (BLA)] filed in 2017,” Novavax President and CEO Stanley Erck said during a Sept. 15 conference call to discuss a preliminary analysis of the Phase III Resolve trial results for the RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine). The news sent the company’s stock down 83.2% to $1.40 per share in after-hours trading

Atara Does An About Face As FDA Lifts Ebvallo Hold

06 May 2025

• By Alaric DeArment

The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.

Lilly And Alchemab Tap Into Resilient Individuals To Develop ALS Drug

06 May 2025

• By Andrew McConaghie

The pharma company is helping to validate the biotech’s model by developing a novel amyotrophic lateral sclerosis candidate, based on its novel approach that ‘turns drug discovery on its head’.