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.