A coronavirus stock if ever there was one, BioNTech (NASDAQ:BNTX) was rising by around 5% in late trading Friday on some excellent regulatory news. It seems that its star product is headed for even greater prominence.
That product is BNT162b2, the coronavirus vaccine BioNTech developed with its big partner, pharmaceutical industry giant Pfizer (NYSE:PFE). BioNTech happily announced Friday morning that the Food and Drug Administration (FDA) has granted the two companies its Priority Review designation for their Biologics License Application for BNT162b2.
The regulator set a goal date for a decision on the BLA of January 2022. But given the enduring threat of the coronavirus, it’s likely the decision will come well before that.
That January 2022 target “does not mean approval will not happen before that time,” Dr. Janet Woodcock, acting FDA commissioner, wrote in a tweet.
“Quite to the contrary, the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance,” she added.
BioNTech and Pfizer finalized the rolling submission of their BLA in May. As it has been since receiving its original Emergency Use Authorization from the FDA last December, BNT162b2 remains a go-to vaccine in the fight against the coronavirus.
An EUA lasts only as long as the applicable emergency (in this case, of course, the pandemic). That’s why the full approval BioNTech seeks is so crucial for BNT162b2’s future. Today’s news, therefore, is very encouraging for shareholders of both companies.
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