Pfizer, Inc. (NYSE: PFE) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the full approval of Paxlovid, its antiviral pill for Covid-19. The drug currently has emergency use authorization (EUA) for the treatment of mild-to-moderate Covid-19.
Albert Bourla, the Chairman and CEO of Pfizer, said, “Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce Paxlovid as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status.”
The NDA submission is based on the results of the Phase 2/3 EPIC-HR study, which demonstrated a reduced risk of hospitalization or death among Covid-19 patients, compared to placebo.
The FDA needs to accept or reject the NDA within two months of submission and has up to 10 months to give a final decision on the approval of the drug.
Federal government figures show that nearly 1.6 million courses of Paxlovid have been administered since it received EUA in December.
Wall Street’s Take
Last month, Bank of America Securities analyst Geoff Meacham reiterated a Buy rating on the stock with a $70 price target (33.5% upside potential).
The analyst said, “We’ve continued to argue that Pfizer should turn its Covid-19 windfall into long-term franchises through aggressive M&A, and we think Pfizer’s acquisition of Arena is likely a first of many shots on goal.”
Overall, the stock has a Moderate Buy consensus rating based on six Buys and nine Holds. PFE’s average price target of $58.64 implies 11.8% upside potential from current levels. Shares have lost 6% over the past six months.
TipRanks data shows that financial bloggers are 94% Bullish on PFE, compared to the sector average of 71%.
Following the announcement on Thursday, PFE stock jumped almost 3% to close at $52.43. J.P. Morgan (NYSE: JPM) analysts expect Pfizer to record Paxlovid sales of around $26 billion in 2022. This could give a further boost to the stock, which has already gained 37% over the past year.
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