Pfizer Receives FDA Breakthrough Therapy Designation for RSVpreF

Pfizer Inc. (PFE) received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF. RSVpreF is designed to prevent lower respiratory tract disease caused by RSV in adults aged 60 years or older.  

American multinational pharmaceutical and biotechnology corporation, Pfizer, is renowned for developing and manufacturing medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. 

Obtaining a BTD gives drugs and vaccines a faster track to regulatory review. 

Supporting Data 

The regulator’s approval followed positive results from a proof-of-concept, Phase 2a study evaluating the efficacy, immunogenicity, and safety of a “single dose of 120µg RSVpreF in a human viral challenge model in healthy adults” between ages 18 and 50 years. 

In September 2021, Pfizer commenced Phase 3 clinical trial (NCT05035212), RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), which is currently ongoing. It was designed to evaluate the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults aged 60 years or older. 

RSV, a contagious virus, is a common cause of respiratory illness. In the U.S., around 177,000 hospitalizations and 14,000 deaths occur annually among older adults due to RSV infections. 

Official Comments 

Reaching the milestone, SVP and Head of Vaccine Research & Development at Pfizer, Kathrin U. Jansen, said, “The clinical and economic burden of RSV represents a critical need, and we look forward to our ongoing dialogue with the FDA to accelerate the development of our RSV vaccine candidate.” 

Analysts Recommendation 

Recently, Cantor Fitzgerald analyst Louise Chen maintained a Buy rating and a price target of $75 (42.61% upside potential) on the stock. 

The rest of the Street is cautiously optimistic about the stock, which has a Moderate Buy consensus rating based on six Buys and eight Holds. The average Pfizer price target of $61.21 implies 16.39% upside potential from current levels. Shares have increased 52.7% over the past year. 

Insider Trading Details 

TipRanks’ Insider Trading tool draws on publicly available information to determine Insider activity on a stock. 

The tool shows that insider confidence in Pfizer is currently Positive, as corporate insiders bought shares worth $9.6 million in the last three months. Notably, Pfizer SVP, Damico Jennifer B. was the insider who made the most transactions on PFE.

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