Pfizer (PFE) Streptococcus Jab Gets FDA's Breakthrough Tag
Pfizer PFE announced that the FDA has granted Breakthrough Therapy Designation to its Group B Streptococcus (GBS) vaccine candidate.
The prestigious designation to the vaccine candidate, GBS6 or PF-06760805 has been given for the prevention of invasive GBS infections due to vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. GBS6 is being evaluated in the phase II study in healthy pregnant women aged 18 to 40 years in South Africa, the United Kingdom, and the United States. Interim data from this study formed the basis for the BTD tag.
The FDA’s BTD designation facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical needs.
Pfizer’s stock is down 21.9% this year so far compared with a decrease of 4.3% for the industry.
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GBS is a common bacterium, which is usually harmless in healthy adults. However, in newborns it can cause serious illnesses like meningitis, pneumonia, and sepsis. At present, prenatal screening and antibiotics during childbirth are mediums used to protect against GBS. However, these are not fully effective in preventing GBS disease, especially beyond the first week of life. If approved for use in pregnant women, the GBS6 vaccine can help prevent GBS disease in newborns.
GBS6 was granted PRIME designation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in April.
Zacks Rank & Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the same sector are Morphic MORF, Sesen Bio SESN and Agenus AGEN, all carrying a Zacks Rank #1 at present.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.75. Loss estimates for 2023 have narrowed from $3.96 to $3.77 during the same period. Shares of Morphic have lost 38.5% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average.
Estimates for Sesen Bio for 2023 have narrowed from a loss of 27 cents per share to a loss of 1 cent per share over the past 60 days. Shares of Sesen Bio have declined 24.4% this year so far.
Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.
Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 21.1% in the year-to-date period.
Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.
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