Shares of Novavax (NVAX 4.64%) were soaring 13.6% higher as of 11:03 a.m. ET on Friday. The big gain came after the U.S. Food and Drug Administration (FDA) announced plans to convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 7. The key focus of this advisory committee meeting will be to discuss the Emergency Use Authorization (EUA) filing submitted by Novavax for its COVID-19 vaccine NVX-CoV2373.
Novavax has experienced multiple delays and setbacks with its pursuit of a U.S. EUA for its COVID-19 vaccine. The FDA's announcement signals that there could be a light at the end of the tunnel.
The FDA hasn't seemed to be in a hurry with processing Novavax's EUA request. Some investors even worried that Novavax's EUA filing had issues that could cause yet another delay. Those worries should evaporate now.
There's a strong case to be made that the FDA's advisory committee will be favorably disposed toward NVX-CoV2373. The COVID-19 vaccine has already received authorizations from more than a dozen other regulatory agencies across the world.
The FDA doesn't have to go along with the recommendation from the VRBPAC. However, the agency often does follow the lead of its advisory panels.
Today's gain for Novavax is justified. Investors shouldn't necessarily bank on the vaccine stock enjoying sustained momentum, though. There are other factors that could cause significant volatility for Novavax's share price, notably including a global supply glut of vaccine doses. But Novavax's prospects of entering the U.S. market now appear to be better than ever with the FDA advisory committee meeting on the calendar.