Bavarian Nordic A/S (CPH:BAVA), a fully integrated biotechnology company focused on the development of therapies against cancer and infectious diseases, announced on Monday the receipt of information from the US Food and Drug Administration (FDA) that the review of the company's Biologics License Application (BLA) for the liquid-frozen formulation of the MVA-BN smallpox vaccine will be extended by three months.

Reportedly the BLA was granted a priority review in December 2018, originally targeting a six months review process. However, the FDA has assessed that due to the amount of data submitted during the review phase, the agency requires more time and has extended the target PDUFA action date to September 2019.

The company added that the BLA maintains priority review status with the FDA and thus Bavarian Nordic would still be eligible to receive a Priority Review Voucher when MVA-BN is approved.

According to the company, the BLA for MVA-BN is unusual as it has already manufactured 28 million doses prior to a full regulatory approval and the development involved generating safety and immunogenicity data from 22 clinical studies. So, while the review process has not raised any significant concerns to date, the MVA-BN BLA is unusually large and the FDA requires more time to complete the review.

This delay will not impact its operations, the company clarified.