Pfizer Inc (NYSE:PFE) is trading higher Wednesday after the company received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for PF-06482077, or RSVpreF, the company's respiratory syncytial virus vaccine candidate.
The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs intended to treat or prevent serious conditions when preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy.
The FDA decision was made after reviewing the results of the Phase 2b proof-of-concept study of RSVpreF, which Pfizer intends to publish at a future date.
"If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus," said Kathrin Jansen, senior vice president and head of vaccine research & development at Pfizer.
President Joe Biden also announced a "test to treat" COVID-19 initiative with antiviral pills on Tuesday, which could be adding to the move Wednesday.
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PFE Price Action: Pfizer has traded as low as $33.44 and as high as $61.71 over a 52-week period.
The stock was up 4.19% at $47.67 Wednesday afternoon.
Photo: Arne Müseler from Flickr.
