Pfizer's Growth Hormone Candidate FDA Review Pushed By 3 Months

  • Pfizer Inc's PFE effort to defend its growth hormone franchise against a new, more convenient competitor has hit a snag. 
  • The FDA has pushed back approval of Pfizer's once-weekly prospect.
  • Ascendis Pharma A/D ASND, after suffering its regulatory delay, won FDA approval for its once-weekly treatment for pediatric growth hormone deficiency (GHD) last month. 
  • Related Content: See Why Ascendis Pharma Stock Is Shining On Thursday.
  • The approval positions Ascendis to start getting the market to switch from existing daily options, such as Pfizer's Genotropin. 
  • Pfizer revealed that the FDA had pushed the decision date three months to January 2022 to review additional data. Pfizer submitted the data, potentially in response to a request from the FDA.
  • In 2014, Pfizer and OPKO Health Inc OPK entered into a worldwide agreement to develop and commercial somatrogon for GHD.
  • Price Action: PFE stock is down 0.18% at $43.86, and OPK stock is down 1.60% at $3.69 during the premarket session on the last check Monday.
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