$175 million milestone in jeopardy as FDA delays Novavax nod
US biotech Novavax (Nasdaq: NVAX) is still waiting on a decision from the Food and Drug Administration over full approval of its protein-based COVID-19 vaccine, despite the agency having set an April 1 target date to complete its review.
The Maryland-based company said it had responded to all outstanding questions from the FDA in advance of the deadline, and considers its biologics license application ready for approval. However, as of this week, the agency had yet to issue an official decision.
Novavax is seeking full approval for NVX-CoV2705, an adjuvanted, protein-based vaccine already authorized under emergency-use provisions. The shot has been positioned as a non-mRNA alternative to those produced by Moderna (Nasdaq: MRNA), and by Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX).
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