American biotechnology firm Novavax Inc. has pushed back its application for an emergency use authorization by another quarter, it announced in a statement.

  • Novavax said it expects to submit emergency use authorization to the US Food and Drug Administration in the fourth quarter of 2021, later than the third quarter it initially reported.
  • The company has found positive results from the clinical study of its influenza and COVID-19 vaccines. It is on track to reach a 100-million dose monthly capacity by end-September, and a 150-million dose monthly capacity by end-2021.
  • The company has partnered with the Serum Institute of India and has already filed regulatory submissions for emergency use in India, Indonesia, and the Philippines.
  • Novavax widened its net loss in the second quarter to $352 million or $4.75 per share versus the net loss of $18 million or $0.30 per share in the same quarter in 2020.

Revenue for the second quarter climbed to $298 million from $36 million in 2020, driven by services for the US government.

NVAX is down 12.45% premarket.