Novavax Wins FDA Fast Track Designation for COVID-19 Vaccine Candidate

Novavax Inc. NVAX,
+ 7.77%
said Monday it had secured fast-track designation from the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, an initiative that is expected to accelerate vaccine development. The company aims to get the candidate, called NVXCoV2373, into a Phase 3 trial in the United States and Mexico by the end of November. “Although regulatory review of this clinical program is being accelerated, Novavax remains committed to a data-driven and scientifically rigorous approach to demonstrate safety and efficacy, which we believe will increase confidence in the vaccine to United States and around the world, ”Gregory M. Glenn, president of R&D at Novavax, said in a statement. Previously Pfizer Inc. PFE,
+ 7.26%
and BioNTech BNTX,
+ 13.32%
said a Phase 3 trial of their vaccine candidate found it to be 90% effective, triggering a major market rally that pushed Dow futures up 1,500 points. Shares of Novavax were down 3% before it went to market, but have gained over 2000% in 2020 so far. The SPDR S&P Biotech ETF XBI,
+ 2.22%
gained 26% and the S&P) 500 SPX,
+ 3.14%
gained 8.6%.