According to a report by CNN, the U.S. Food and Drug Administration (FDA) has granted priority review designation to global pharmaceutical and biotechnology company Pfizer (PFE) and BioNTech SE’s (BNTX) application for full approval of their COVID-19 vaccine.
BioNTech is a German biotechnology firm that makes immunotherapies for autoimmune disorders, allergies, infectious diseases and cancer.
The FDA is likely to reach a decision on the vaccine’s full approval within two months.
The companies started filing Biologics License Application for full approval in May. They are seeking to get the vaccine approved for people at least 16 years of age. (See Pfizer stock chart on TipRanks)
Once the data is available, Pfizer and BioNTech further plan to seek approval for the two-dose vaccine for people between 12 and 15 years of age. (See BioNTech stock chart on TipRanks)
The Acting FDA Commissioner, Janet Woodcock, said, “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 of the… Goal Date.”
Two months ago, Argus Research analyst David Toung reiterated a Buy rating on Pfizer with a price target of $55 (36.3% upside potential).
The analyst said, “While the company is scaling up the manufacturing to meet its commitment to deliver a billion doses of coronavirus vaccine by the end of 2021, the market is still underestimating the sustainability of the COVID-19 vaccine franchise and its revenue contribution beyond this year.”
Overall, the stock has a Hold consensus based on 1 Buy, 9 Holds and 1 Sell. The average Pfizer price target of $43.22 implies 7.1% upside potential. Shares of Pfizer have gained 16.7% over the past year.
Last week, H.C. Wainwright analyst Robert Burns maintained a Hold rating on BioNTech with a price target of $194 (16.2% downside potential). For the third quarter, the analyst expects the company to report earnings per share (EPS) of $4.64.
Overall, the stock has a Hold consensus based on 2 Buys, 5 Holds and 1 Sell. The average BioNTech price target of $189.6 implies 18.1% downside potential. Shares have gained 162.4% over the past year.
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