From Yahoo Finance: 2025-05-08 08:06:00

Novavax reassured investors about the delay in full approval of its COVID vaccine by U.S. regulators. The company sees a pathway to resolve issues with the FDA, boosting shares by 19%. Talks with the agency on study design are ongoing, with hopes for full approval to expand use and compete with rivals.

The Maryland-based biotech Novavax swung to profit in the first quarter, driven by reduced costs related to its COVID-19 vaccine. Quarterly revenue rose to $667 million, surpassing estimates, mainly due to termination of purchase agreements in Canada and New Zealand. The company expects adjusted total revenue for 2025 to be between $975 million and $1.03 billion.

Read more: Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears